Joanne Levy

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials.  Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth.  Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients contributed to research learning. JoAnne has served in the healthcare industry for almost 30 years. She leads Mercy Research, a not-for-profit organization managing clinical and real-world-evidence research activities across Mercy. JoAnne serves as current Chair and inaugural founder of Mercy Women in Leadership Council and as a member of Mercy’s Diversity, Equity, Inclusion and Belonging Advisory Board. JoAnne received her undergraduate, law and master of business administration degrees — all with honors — from Washington University in St. Louis.  Please join me in welcoming JoAnne on the Clinical Trial Podcast.  This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/. This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials.  Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth.  Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients contributed to research learning. JoAnne has served in the healthcare industry for almost 30 years. She leads Mercy Research, a not-for-profit organization managing clinical and real-world-evidence research activities across Mercy. JoAnne serves as current Chair and inaugural founder of Mercy Women in Leadership Council and as a member of Mercy’s Diversity, Equity, Inclusion and Belonging Advisory Board. JoAnne received her undergraduate, law and master of business administration degrees — all with honors — from Washington University in St. Louis.  Please join me in welcoming JoAnne on the Clinical Trial Podcast.  This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit <a href="https://sites.veeva.com/" rel="nofollow" target="_blank">https://sites.veeva.com/</a>. This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at <a href="http://slopeclinical.com" rel="nofollow" target="_blank">slopeclinical.com</a>

Community health system-based research with JoAnne Levy

David Rutledge

In this episode, we’re going to talk about Postmarket Surveillance Studies.  In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.  The importance of such studies has grown in recent years as regulators want to know about the safety and effectiveness during the lifetime of a medical device.  To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast. David is the President &amp; CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations.  David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs.  David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, and author of Mythical Medical™: Revelations from a Global Product Approval Consultant.  * This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com  This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/ *

In this episode, we’re going to talk about Postmarket Surveillance Studies.  In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.  The importance of such studies has grown in recent years as regulators want to know about the safety and effectiveness during the lifetime of a medical device.  To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast. David is the President &amp; CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations.  David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs.  David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, and author of Mythical Medical™: Revelations from a Global Product Approval Consultant.  * This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit <a href="https://florencehc.com/" rel="nofollow" target="_blank">https://florencehc.com </a> This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit <a href="https://www.calyx.ai/" rel="nofollow" target="_blank">https://www.calyx.ai/</a> *

Postmarket Surveillance Studies with David Rutledge

Bruce Hellman

Ben James

In this episode, we explore the role of design in clinical trials. Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials. One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and completed by clinical trial participants as part of the study requirements.  To learn more about ePROs and the role of design in clinical trials, I invited Bruce Hellman and Ben James on the Clinical Trial Podcast.  Ben is the Chief Design Officer and Co-founder at uMotif. Bruce is the Chief Patient Officer &amp; Co-Founder at uMotif. Please join me in welcoming Bruce and Ben on the Clinical Trial Podcast. * This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com  *

In this episode, we explore the role of design in clinical trials. Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials. One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and completed by clinical trial participants as part of the study requirements.  To learn more about ePROs and the role of design in clinical trials, I invited Bruce Hellman and Ben James on the Clinical Trial Podcast.  Ben is the Chief Design Officer and Co-founder at uMotif. Bruce is the Chief Patient Officer &amp; Co-Founder at uMotif. Please join me in welcoming Bruce and Ben on the Clinical Trial Podcast. * This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at <a href="http://slopeclinical.com" rel="nofollow" target="_blank">slopeclinical.com</a> This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit <a href="https://florencehc.com/" rel="nofollow" target="_blank">https://florencehc.com </a> *

Human-centered design role in clinical trials with Bruce Hellman and Ben James

There are advantages and disadvantages when it comes to being a standalone clinical trial site.  Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.  This is where site networks come in.  For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network. To learn more about site networks, I invited Christian Burns, President of Elligo Health Research and Co-Founder of ClinX, on the show. Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research.  Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials.  With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian's companies have served patients and providers across thousands of research sites globally.  His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem.  A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa. Enjoy! Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/. This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io. 

There are advantages and disadvantages when it comes to being a standalone clinical trial site.  Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.  This is where site networks come in.  For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network. To learn more about site networks, I invited Christian Burns, President of Elligo Health Research and Co-Founder of ClinX, on the show. Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research.  Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials.  With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian's companies have served patients and providers across thousands of research sites globally.  His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem.  A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa. Enjoy! Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit <a href="https://sites.veeva.com/" rel="nofollow" target="_blank">https://sites.veeva.com/</a>. This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit <a href="https://www.slope.io/" rel="nofollow" target="_blank">slope.io</a>.

Clinical Trial Site Networks with Christian Burns

In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices. Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart. At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations. Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle. Sonna has extensive experience in the heart failure medical device space. Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more. In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more. Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being. I hope you enjoy my conversation with Sonna Patel-Raman.  Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/. This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io. 

In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices. Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart. At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations. Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle. Sonna has extensive experience in the heart failure medical device space. Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more. In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more. Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being. I hope you enjoy my conversation with Sonna Patel-Raman.  Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit <a href="https://sites.veeva.com/" rel="nofollow" target="_blank">https://sites.veeva.com/</a>. This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit <a href="https://www.slope.io/" rel="nofollow" target="_blank">slope.io</a>.

Heart Failure Clinical Trials with Sonna Patel-Raman

To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical.  Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical trials. Kelie believes it is possible to improve the efficiency of how clinical trials with imaging-based endpoints are conducted while also improving the reliability of data abstracted from participants during clinical trials.  She holds a B.S and M.S in Chemistry along with a Master’s in Technical, Scientific, and Medical Communication.  Sponsor: This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical.  Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical trials. Kelie believes it is possible to improve the efficiency of how clinical trials with imaging-based endpoints are conducted while also improving the reliability of data abstracted from participants during clinical trials.  She holds a B.S and M.S in Chemistry along with a Master’s in Technical, Scientific, and Medical Communication.  Sponsor: This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit <a href="https://www.calyx.ai/" rel="nofollow" target="_blank">https://www.calyx.ai/</a>

Medical Imaging for Clinical Trial Sites with Kelie Luby

Bijan Elahi

This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose. You’ll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. You’ll also understand key terminology around risks, how to define risk, what's special about clinical studies with respect to risk management, and much more. Our guest today is Bijan Elahi. Bijan has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a technical fellow and Medtronic corporate advisor on safety risk management of. medical devices.  In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide.  Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he also teaches a graduate course on medical device risk management at Drexel University in Philadelphia. Bijan is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 6,500 individuals worldwide. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices.  Last but not least, he is the author of Safety Risk Management for Medical Devices, published by Elsevier publishing. Enjoy! Sponsor: This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform.  To learn more, visit slope.io and ask to speak with a solutions coordinator today.

This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose. You’ll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. You’ll also understand key terminology around risks, how to define risk, what's special about clinical studies with respect to risk management, and much more. Our guest today is Bijan Elahi. Bijan has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a technical fellow and Medtronic corporate advisor on safety risk management of. medical devices.  In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide.  Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he also teaches a graduate course on medical device risk management at Drexel University in Philadelphia. Bijan is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 6,500 individuals worldwide. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices.  Last but not least, he is the author of Safety Risk Management for Medical Devices, published by Elsevier publishing. Enjoy! Sponsor: This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform.  To learn more, visit <a href="https://www.slope.io/" rel="nofollow" target="_blank">slope.io</a> and ask to speak with a solutions coordinator today.

Risk Management for Clinical Investigators with Bijan Elahi

Kunal Sampat

In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings.  Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs).  These meetings are exceptionally critical to the success of any medical product development. The purpose of these meetings is to discuss the clinical trial strategy, clinical investigational plan, patient enrollment initiatives, publication plan, and more. Although it entirely possible to conduct these meetings virtually (and sometimes you’re better off conducting them virtually), the focus of this episode is on in-person meetings. But most meetings tend to poorly organized with lack of purpose and defined objectives i.e. what is it that you hope to achieve by conducting this meeting. If you’re directly or in-directly involved in organizing a meeting with KOLs, this episode will serve you well. This episode is brought to you by Calyx. To learn more on how Calyx can help you with your medical imaging needs, please visit calyx.ai

In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings.  Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs).  These meetings are exceptionally critical to the success of any medical product development. The purpose of these meetings is to discuss the clinical trial strategy, clinical investigational plan, patient enrollment initiatives, publication plan, and more. Although it entirely possible to conduct these meetings virtually (and sometimes you’re better off conducting them virtually), the focus of this episode is on in-person meetings. But most meetings tend to poorly organized with lack of purpose and defined objectives i.e. what is it that you hope to achieve by conducting this meeting. If you’re directly or in-directly involved in organizing a meeting with KOLs, this episode will serve you well. This episode is brought to you by Calyx. To learn more on how Calyx can help you with your medical imaging needs, please visit <a href="http://calyx.ai" rel="nofollow" target="_blank">calyx.ai</a>

5 Strategies for Investigator and Steering Committee Meetings with Kunal Sampat

Anca Copaescu

Clinical Trial Outsourcing with Anca Copaescu

When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe? To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. To learn more about the complexities in early phase clinical trials, I invited Dr. Oren Cohen, President of Clinical Pharmacology Services and Chief Medical Officer at Labcorp Drug Development on the show. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development.  I hope you enjoy this conversation with Dr. Oren Cohen. Podcast Sponsor: This podcast episode is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit calyx.ai 

When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe? To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. To learn more about the complexities in early phase clinical trials, I invited Dr. Oren Cohen, President of Clinical Pharmacology Services and Chief Medical Officer at Labcorp Drug Development on the show. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development.  I hope you enjoy this conversation with Dr. Oren Cohen. Podcast Sponsor: This podcast episode is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit <a href="https://calyx.ai" rel="noopener nofollow" target="_blank">calyx.ai </a>

Complexity in Early Phase Clinical Trials with Dr. Oren Cohen

Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career.You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals. To learn more, visit https://clinicaltrialpodcast.com/

As a pharmacist looking to get into the clinical research industry, I have found The Clinical Trial Podcast indispensable. Kunal&#39;s articles about gaining experience are especially helpful. I have put his advice into action, and am making progress! If you are looking to get into or improve yourself in this industry, listen to this podcast!!

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I work in the clinical research industry and found this podcast to be helpful and engaging. Thanks Kunal.

Great information with interesting discussions

Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals. To learn more, visit <a href="https://clinicaltrialpodcast.com/" rel="nofollow" target="_blank">https://clinicaltrialpodcast.com/</a>

Clinical Trial Podcast | Conversations with Clinical Research Experts

Jessie Coe

In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training. Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott’s flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan. Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and management of clinical research organizations (CROs). In this episode, I had an opportunity to speak with Jessie about how to get into clinical research, outsourcing and supplier management, the evolution of the CRA role and much more. Please join me in welcome Jessie to the Clinical Trial Podcast. Show Notes:  Getting into clinical research via technical roles such as data management and biometrics What makes a great statistician? Experience gained working for a big and small company Writing a statistical analysis plan Making CRO-Sponsor relationship work and how to succeed with outsourcing Getting unstuck - understanding how CROs and sponsors work Identifying clinical safety gaps and plugging in a CRO Protecting yourself as a sponsor when you outsource safety Working with CRO through iterations and why RACI may not work for you Outsourcing clinical events committee (CEC) and data safety committee (DMC) MEDRA coding: how it works, automation, generic versus specific coding Reducing CRO/ outsourcing budget and how to do it? Evolution of CRA role - drafting a protocol to writing reports Key Performance Indicators (KPIs) for a clinical research organization Turnover at a CRO and why it matters Financial KPI - money spent relative to the actions that were supposed to happen with that money Developing a process mindset - 5 major things that need to happen from beginning to end Evaluating employee performance relative to others Standing out by managing a chaotic situation, managing senior management discussions, ability to move the conversation along to get to a conclusion, working on “hot” projects that delivered results   Volunteer yourself to get involved Moving beyond conference calls and emails - pick up the phone and talk to someone Clinical research is about working in a field where your work really matters 

In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training. Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott’s flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan. Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and management of clinical research organizations (CROs). In this episode, I had an opportunity to speak with Jessie about how to get into clinical research, outsourcing and supplier management, the evolution of the CRA role and much more. Please join me in welcome Jessie to the Clinical Trial Podcast. Show Notes: <ul> <li>Getting into clinical research via technical roles such as data management and biometrics</li> <li>What makes a great statistician?</li> <li>Experience gained working for a big and small company</li> <li>Writing a statistical analysis plan</li> <li>Making CRO-Sponsor relationship work and how to succeed with outsourcing</li> <li>Getting unstuck - understanding how CROs and sponsors work</li> <li>Identifying clinical safety gaps and plugging in a CRO</li> <li>Protecting yourself as a sponsor when you outsource safety</li> <li>Working with CRO through iterations and why RACI may not work for you</li> <li>Outsourcing clinical events committee (CEC) and data safety committee (DMC)</li> <li>MEDRA coding: how it works, automation, generic versus specific coding</li> <li>Reducing CRO/ outsourcing budget and how to do it?</li> <li>Evolution of CRA role - drafting a protocol to writing reports</li> <li>Key Performance Indicators (KPIs) for a clinical research organization</li> <li>Turnover at a CRO and why it matters</li> <li>Financial KPI - money spent relative to the actions that were supposed to happen with that money</li> <li>Developing a process mindset - 5 major things that need to happen from beginning to end</li> <li>Evaluating employee performance relative to others</li> <li>Standing out by managing a chaotic situation, managing senior management discussions, ability to move the conversation along to get to a conclusion, working on “hot” projects that delivered results  </li> <li>Volunteer yourself to get involved</li> <li>Moving beyond conference calls and emails - pick up the phone and talk to someone</li> <li>Clinical research is about working in a field where your work really matters</li> </ul>

Getting Intro Research and CRO Partnerships with Jessie Coe

Blake Peters

Clinical trial finance is a key area of clinical trials and clinical research.  Human beings are innately not good with numbers and clinical trial finance is no exception.  Creating study budgets, forecasting clinical trial costs, and managing trial finances are essential skills for any clinical research professional.  This is true for sites, vendors, CROs, and Sponsor personnel, irrespective of whether they have direct responsibility for clinical trial finances.  In this episode, I had the opportunity to speak with my friend Blake Peters who is exceptional at what he does with clinical trial finances.   Blake is currently an Associate Director, Clinical Research at Abbot Labs.   I’m excited to bring Blake on the show given his extensive experience managing multi-million dollar clinical trial budgets.  We had an excellent conversation on a variety of topics such as careers, being resourceful, clinical trial finance, storytelling and presentation skills, and much more.  I hope you enjoy this interview with Blake.  Blake Peters on LinkedIn.  How does one make a transition into clinical research? Core skills   Bringing value to your team Helping clinical project managers forecast and estimate clinical trial costs Excel skills Data analytics Financial mindset Continued curiosity to learn and grow   Transitioning from finance to clinical research    Learning about the conduct of clinical trials Therapeutic knowledge On the job training A clinical research training conference   Working with clinical project manager on finances    Challenging clinical trial assumptions to optimize financing Historic data on benchmarking   Hospitals are required to publish procedure costs Collaboration with finance on clinical trials and research   Alignment on vocabulary, a common understanding of what each if try to talk about   Maslow’s Law of Hierarchy for Clinical Trial Costs    Cost of the clinical trial - a list of expense type Cost driver - how to multiply the expense, scales with sites and/or patients or fixed expenses Timing of these expenses  Factors that change the cost Total trial cost    Clinical Research Organization (CRO) budget - ensuring you are not overspending when you decide to outsource   Review project management fees Review monitoring costs Categorize costs into buckets or functional costs (safety, data management, operations, etc.)   Becoming proficient in Microsoft Excel    What do you find yourself doing manually and/or repeatedly? Be resourceful Spending 5-10 minutes can save you tens or hundreds of hours Research solutions (Youtube, Google) and implement   Powerpoint skills in clinical research    Understanding the message Meeting with the stakeholders Think about table vs. graphs vs. graphics Don’t overdo animations First, get the content on the slide and then focus on the aesthetics of your slides Iterate, hit save and look at it again the next morning   Types of PowerPoint slides   Speak for itself with clean design Reference manual  Different audience/ use cases   Slides are an outward representation of the person who built them. They serve as an opportunity to show your creativity and can open doors for you Valuable skills for clinical research professionals   Listening Public speaking/ storytelling   Passion and inspiration Managing stress with diet, meditation, drinking a lot of water   Resources mentioned:  Abbott   What Got You Here Won't Get You There: How Successful People Become Even More Successful by Marshall Goldsmith

Clinical trial finance is a key area of clinical trials and clinical research.  Human beings are innately not good with numbers and clinical trial finance is no exception.  Creating study budgets, forecasting clinical trial costs, and managing trial finances are essential skills for any clinical research professional.  This is true for sites, vendors, CROs, and Sponsor personnel, irrespective of whether they have direct responsibility for clinical trial finances.  In this episode, I had the opportunity to speak with my friend Blake Peters who is exceptional at what he does with clinical trial finances.   Blake is currently an Associate Director, Clinical Research at Abbot Labs.   I’m excited to bring Blake on the show given his extensive experience managing multi-million dollar clinical trial budgets.  We had an excellent conversation on a variety of topics such as careers, being resourceful, clinical trial finance, storytelling and presentation skills, and much more.  I hope you enjoy this interview with Blake.  <a href="https://www.linkedin.com/in/blakepeters/" rel="nofollow" target="_blank">Blake Peters</a> on LinkedIn. <ul> <li>How does one make a transition into clinical research?</li> <li>Core skills</li> <li> <ul> <li>Bringing value to your team</li> <li>Helping clinical project managers forecast and estimate clinical trial costs</li> <li>Excel skills</li> <li>Data analytics</li> <li>Financial mindset</li> <li>Continued curiosity to learn and grow</li> </ul> </li> <li>Transitioning from finance to clinical research </li> <li> <ul> <li>Learning about the conduct of clinical trials</li> <li>Therapeutic knowledge</li> <li>On the job training</li> <li>A clinical research training conference</li> </ul> </li> <li>Working with clinical project manager on finances </li> <li> <ul> <li>Challenging clinical trial assumptions to optimize financing</li> <li>Historic data on benchmarking</li> </ul> </li> <li>Hospitals are required to publish procedure costs</li> <li>Collaboration with finance on clinical trials and research</li> <li> <ul> <li>Alignment on vocabulary, a common understanding of what each if try to talk about</li> </ul> </li> <li>Maslow’s Law of Hierarchy for Clinical Trial Costs </li> <li> <ul> <li>Cost of the clinical trial - a list of expense type</li> <li>Cost driver - how to multiply the expense, scales with sites and/or patients or fixed expenses</li> <li>Timing of these expenses </li> <li>Factors that change the cost</li> <li>Total trial cost </li> </ul> </li> <li>Clinical Research Organization (CRO) budget - ensuring you are not overspending when you decide to outsource</li> <li> <ul> <li>Review project management fees</li> <li>Review monitoring costs</li> <li>Categorize costs into buckets or functional costs (safety, data management, operations, etc.)</li> </ul> </li> <li>Becoming proficient in Microsoft Excel </li> <li> <ul> <li>What do you find yourself doing manually and/or repeatedly?</li> <li>Be resourceful</li> <li>Spending 5-10 minutes can save you tens or hundreds of hours</li> <li>Research solutions (Youtube, Google) and implement</li> </ul> </li> <li>Powerpoint skills in clinical research </li> <li> <ul> <li>Understanding the message</li> <li>Meeting with the stakeholders</li> <li>Think about table vs. graphs vs. graphics</li> <li>Don’t overdo animations</li> <li>First, get the content on the slide and then focus on the aesthetics of your slides</li> <li>Iterate, hit save and look at it again the next morning</li> </ul> </li> <li>Types of PowerPoint slides</li> <li> <ul> <li>Speak for itself with clean design</li> <li>Reference manual </li> <li>Different audience/ use cases</li> </ul> </li> <li>Slides are an outward representation of the person who built them. They serve as an opportunity to show your creativity and can open doors for you</li> <li>Valuable skills for clinical research professionals</li> <li> <ul> <li>Listening</li> <li>Public speaking/ storytelling</li> </ul> </li> <li>Passion and inspiration</li> <li>Managing stress with diet, meditation, drinking a lot of water </li> </ul> Resources mentioned: <ul> <li><a href="http://abbott.com" rel="nofollow" target="_blank">Abbott</a></li> </ul> <a href="https://www.amazon.com/What-Got-Here-Wont-There/dp/1401301304/ref=tmm_hrd_swatch_0?_encoding=UTF8&amp;qid=1590459036&amp;sr=1-2" rel="nofollow" target="_blank"> What Got You Here Won't Get You There: How Successful People Become Even More Successful</a> by Marshall Goldsmith

Managing and Communicating Clinical Trial Finances with Blake Peters

CTP 020: 17 Strategies to Increase Patient Recruitment in Clinical Trials

This is a solo episode where I share with you “13 Suggestions for Becoming a Great Clinical Project Manager.” If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested in learning about what are the roles and responsibilities of a clinical project manager. In this episode, I’ll share with you the fundamentals, tactics and soft skills that turn a good project manager into a great project manager. At the most basic level, a project manager must be familiar with the clinical study protocol, clinical study procedure(s), and Good Clinical Practice (GCP) requirements. Next, a clinical project manager needs to be savvy with creating and managing study budgets, timelines and resources. Finally, the soft skills make a world of a difference between a good project manager and a great project manager. I’ll share with you 6 specific soft skills that will help you exponentially if you are really serious about the clinical project manager role. Thanks to my blog reader Christopher B. for recommending this topic. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. About This Podcast Episode: Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode:  Connect with me (Kunal)  LinkedIn | Twitter   The Ultimate Guide to Clinical Trial Costs  FDA Good Clinical Practice Guidance Learn Microsoft Excel and other Microsoft Office Tools  SkillShare Udemy YouTube   Microsoft Office Products  Microsoft Project to create timelines Microsoft Excel to create and manage study budgets and timelines Office Timeline, a Microsoft Powerpoint plugin that helps you create beautiful clinical trial timelines   Create graphics and slides using Canva  Books Mentioned:  Sapiens: A Brief History of Humankind by Yuval Noah Harari The Inevitable: Understanding the 12 Technological Forces That Will Shape Our Future by Kevin Kelly  Show Notes:  Protocol, follow-up requirements and adverse event reporting [01:26] Understanding the clinical procedure [4:42] Good Clinical Practice [6:02] Managing a clinical study budget [7:20] Proficiency with Microsoft Excel [8:22] Developing and executing on study timelines [14:41] Managing study resources [22:05] Paying attention to compliance [24:02] Being self-aware [28:13] Being objective in your decision-making process [29:40] Being proactive and results driven [31:04] Ask questions and be curious [32:58] Explain your thought process [36:40] How to communicate effectively [38:05]  QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

This is a solo episode where I share with you “13 Suggestions for Becoming a Great Clinical Project Manager.” If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested in learning about what are the roles and responsibilities of a clinical project manager. In this episode, I’ll share with you the fundamentals, tactics and soft skills that turn a good project manager into a great project manager. At the most basic level, a project manager must be familiar with the clinical study protocol, clinical study procedure(s), and Good Clinical Practice (GCP) requirements. Next, a clinical project manager needs to be savvy with creating and managing study budgets, timelines and resources. Finally, the soft skills make a world of a difference between a good project manager and a great project manager. I’ll share with you 6 specific soft skills that will help you exponentially if you are really serious about the clinical project manager role. Thanks to my blog reader Christopher B. for recommending this topic. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. About This Podcast Episode: Listen to it on <a href="https://itunes.apple.com/us/podcast/clinical-trial-podcast-conversations-clinical-research/id1272290761" rel="nofollow noopener" target="_blank">iTunes</a>.Stream by <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP004.mp3" rel="noopener nofollow" target="_blank">clicking here</a>.Download as an MP3 by <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP004.mp3" rel="nofollow noopener" target="_blank">right-clicking here</a> and choosing “save as.” Selected Links from the Episode: <ul> <li>Connect with me (Kunal)</li> </ul> <a href="https://www.linkedin.com/in/kunalsampat/" rel="nofollow noopener" target="_blank">LinkedIn</a> | <a href="https://twitter.com/kunal_sampat" rel="nofollow noopener" target="_blank">Twitter</a> <ul> <li><a href="http://clinicaltrialpodcast.com/ultimate-guide-to-clinical-trial-costs/" rel="nofollow" target="_blank"> The Ultimate Guide to Clinical Trial Costs</a></li> <li><a href="https://www.fda.gov/downloads/drugs/guidances/ucm073122.pdf" rel="nofollow" target="_blank"> FDA Good Clinical Practice Guidance</a></li> <li>Learn Microsoft Excel and other Microsoft Office Tools <ul> <li><a href="http://skl.sh/1XtbQyy" rel="nofollow noopener" target="_blank">SkillShare</a></li> <li><a href="https://www.udemy.com/" rel="nofollow noopener" target="_blank">Udemy</a></li> <li><a href="https://www.youtube.com/" rel="nofollow" target="_blank">YouTube</a></li> </ul> </li> <li>Microsoft Office Products <ul> <li><a href="https://products.office.com/en-us/project/project-and-portfolio-management-software?tab=tabs-1" rel="nofollow noopener" target="_blank">Microsoft Project</a> to create timelines</li> <li><a href="https://products.office.com/en-us/excel" rel="nofollow noopener" target="_blank">Microsoft Excel</a> to create and manage study budgets and timelines</li> <li><a href="https://www.officetimeline.com/download" rel="nofollow noopener" target="_blank">Office Timeline</a>, a <a href="https://products.office.com/en-us/powerpoint" rel="nofollow noopener" target="_blank">Microsoft Powerpoint</a> plugin that helps you create beautiful clinical trial timelines</li> </ul> </li> <li>Create graphics and slides using <a href="https://www.canva.com/" rel="nofollow noopener" target="_blank">Canva</a></li> </ul> Books Mentioned: <ul> <li><a href="http://amzn.to/2gjirRZ" rel="nofollow" target="_blank">Sapiens: A Brief History of Humankind</a> by Yuval Noah Harari</li> <li><a href="http://amzn.to/2vBQYx3" rel="nofollow" target="_blank">The Inevitable: Understanding the 12 Technological Forces That Will Shape Our Future</a> by Kevin Kelly</li> </ul> Show Notes: <ul> <li>Protocol, follow-up requirements and adverse event reporting [01:26]</li> <li>Understanding the clinical procedure [4:42]</li> <li>Good Clinical Practice [6:02]</li> <li>Managing a clinical study budget [7:20]</li> <li>Proficiency with Microsoft Excel [8:22]</li> <li>Developing and executing on study timelines [14:41]</li> <li>Managing study resources [22:05]</li> <li>Paying attention to compliance [24:02]</li> <li>Being self-aware [28:13]</li> <li>Being objective in your decision-making process [29:40]</li> <li>Being proactive and results driven [31:04]</li> <li>Ask questions and be curious [32:58]</li> <li>Explain your thought process [36:40]</li> <li>How to communicate effectively [38:05]</li> </ul> QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

CTP 004: 13 Suggestions for Becoming a Great Clinical Project Manager

Norman Goldfarb

In this interview, Norm and I dig deep into the business of clinical research. You’ll hear us talking about what it takes to run a clinical trial site, the importance of clinical research training and certifications, negotiation strategies, remote monitoring, challenges of being a research coordinator, our love for Ben Franklin and much, much more. Hope you enjoy my interview with the all amazing Norman Goldfarb. About Norman Goldfarb Norman Goldfarb is a seasoned executive and leading authority on clinical research best practices. He has authored or presented hundreds of articles and talks on clinical research. He is Managing Director of First Clinical Research, Editor of the Journal of Clinical Research Best Practices, and Chairman of MAGI. Show Notes:  Norm’s transition from high tech to clinical research via his work on a patient recruitment software [01:53] Why clinical research site business is a hard business [04:28] The career path of site principal investigators [06:20] Advice for recent graduates in the field of medicine  [10:30] Challenges of being a study coordinator and how to overcome them [12:15] Pros and cons of remote monitoring [15:45] Importance of standardization in research [20:03] Model Clinical Trial Agreement Template [23:35] Resources of study coordinators negotiating clinical trial agreements [24:55] Ben Franklin [28:01] On writing controversial articles in clinical research  [29:45] Certification in clinical research and does it matter [31:01] On negotiation  [36:04] Two-year requirement for taking certification exams and what matters most in clinical research [40:25] High road marketing [49:31] Philosopher's Stone [53:29] Why should someone be in clinical research in the first place? [56:57] 

In this interview, Norm and I dig deep into the business of clinical research. You’ll hear us talking about what it takes to run a clinical trial site, the importance of clinical research training and certifications, negotiation strategies, remote monitoring, challenges of being a research coordinator, our love for Ben Franklin and much, much more. Hope you enjoy my interview with the all amazing Norman Goldfarb. About Norman Goldfarb Norman Goldfarb is a seasoned executive and leading authority on clinical research best practices. He has authored or presented hundreds of articles and talks on clinical research. He is Managing Director of First Clinical Research, Editor of the Journal of Clinical Research Best Practices, and Chairman of MAGI. Show Notes: <ul> <li>Norm’s transition from high tech to clinical research via his work on a patient recruitment software [01:53]</li> <li>Why clinical research site business is a hard business [04:28]</li> <li>The career path of site principal investigators [06:20]</li> <li>Advice for recent graduates in the field of medicine  [10:30]</li> <li>Challenges of being a study coordinator and how to overcome them [12:15]</li> <li>Pros and cons of remote monitoring [15:45]</li> <li>Importance of standardization in research [20:03]</li> <li>Model Clinical Trial Agreement Template [23:35]</li> <li>Resources of study coordinators negotiating clinical trial agreements [24:55]</li> <li>Ben Franklin [28:01]</li> <li>On writing controversial articles in clinical research  [29:45]</li> <li>Certification in clinical research and does it matter [31:01]</li> <li>On negotiation  [36:04]</li> <li>Two-year requirement for taking certification exams and what matters most in clinical research [40:25]</li> <li>High road marketing [49:31]</li> <li>Philosopher's Stone [53:29]</li> <li>Why should someone be in clinical research in the first place? [56:57]</li> </ul>

CTP 008: Exceptional Clinical Research Insights with Norman Goldfarb

“I enjoy conversations. It takes you somewhere different” - Gabriel D'Amico-Mazza Gabriel is one of the most positive and enthusiastic individuals I know in clinical research. This was one of the main reasons I wanted him to be on this show. He is an expert in business development at a clinical trial site, GCP Research, in Quebec, Canada. Since joining GCP Research in 2010, Gabriel has led recruitment and advertising for Phase 2 and Phase 3 clinical studies. He has been involved in over 40 clinical studies and has been an integral part of the growth of GCP Research. Gabriel graduated from Concordia University with a BSc and a Specialization in Biology. He has also finished a follow-up Graduate Diploma program in Health Care Management from McGill University.Please join me in this fun and insightful conversation with Gabriel D’Amico-MazzaAbout This Podcast Episode Listen to it on  iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode  Connect with Gabriel D'Amico-Mazza on LinkedIn GCP Research Facebook Blueprint Health Canada Vantage Biotrials Clinical Research Association of Canada Association of Clinical Research Professionals Society of Clinical Research Associates  Show Notes:  Business development for clinical trials [01:06] Recruiting participants, why people want to be in clinical trials [02:36] The composition of a small site in clinical research [11:05] Process for building relationships with a network of doctors and specialists [13:20] Three things that motivate physicians  [16:50] How doctors get paid in a hospital setting [20:04] Average bill rate for a general practitioner in Canada [21:16] Gabriel's journey from college to clinical research [24:02] Working with Quebec sites if you are a sponsor or CRO personnel from another country [28:00] Social media marketing to recruit trial patients [32:00] Key Performance Indicators (KPIs) at GCP Research [45:20] How to get feedback to improve clinical trial conduct [52:05] Attending clinical research conference [56:28] Email vs. calling people and why picking up the phone makes a difference [59:55]  What was your favorite part of this interview? Let me know in the comments section below.

“I enjoy conversations. It takes you somewhere different” - Gabriel D'Amico-Mazza Gabriel is one of the most positive and enthusiastic individuals I know in clinical research. This was one of the main reasons I wanted him to be on this show. He is an expert in business development at a clinical trial site, GCP Research, in Quebec, Canada. Since joining GCP Research in 2010, Gabriel has led recruitment and advertising for Phase 2 and Phase 3 clinical studies. He has been involved in over 40 clinical studies and has been an integral part of the growth of GCP Research. Gabriel graduated from Concordia University with a BSc and a Specialization in Biology. He has also finished a follow-up Graduate Diploma program in Health Care Management from McGill University.Please join me in this fun and insightful conversation with Gabriel D’Amico-MazzaAbout This Podcast Episode Listen to it on <a href="https://itunes.apple.com/us/podcast/clinical-trial-podcast-conversations-clinical-research/id1272290761?mt=2" rel="nofollow" target="_blank"> iTunes</a>.Stream by clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_010.mp3" rel="nofollow noopener" target="_blank">here</a>.Download as an MP3 by right-clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_010.mp3" rel="nofollow noopener" target="_blank">here</a> and choosing “save as.” Selected Links from the Episode <ul> <li>Connect with <a href="https://www.linkedin.com/in/gabriel-d-amico-mazza-27838565/" rel="nofollow noopener" target="_blank">Gabriel D'Amico-Mazza on LinkedIn</a></li> <li><a href="http://www.montrealclinicaltrials.com/team_page.php" rel="noopener nofollow" target="_blank">GCP Research</a></li> <li><a href="https://www.facebook.com/blueprint" rel="nofollow noopener" target="_blank">Facebook Blueprint</a></li> <li><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials.html" rel="nofollow noopener" target="_blank">Health Canada</a></li> <li><a href="http://www.vantagebiotrials.com/" rel="nofollow noopener" target="_blank">Vantage Biotrials</a></li> <li><a href="http://www.craconline.ca/" rel="nofollow noopener" target="_blank">Clinical Research Association of Canada</a></li> <li><a href="https://www.acrpnet.org/" rel="nofollow noopener" target="_blank">Association of Clinical Research Professionals</a></li> <li><a href="https://www.socra.org/" rel="nofollow noopener" target="_blank">Society of Clinical Research Associates</a></li> </ul> Show Notes: <ul> <li>Business development for clinical trials [01:06]</li> <li>Recruiting participants, why people want to be in clinical trials [02:36]</li> <li>The composition of a small site in clinical research [11:05]</li> <li>Process for building relationships with a network of doctors and specialists [13:20]</li> <li>Three things that motivate physicians  [16:50]</li> <li>How doctors get paid in a hospital setting [20:04]</li> <li>Average bill rate for a general practitioner in Canada [21:16]</li> <li>Gabriel's journey from college to clinical research [24:02]</li> <li>Working with Quebec sites if you are a sponsor or CRO personnel from another country [28:00]</li> <li>Social media marketing to recruit trial patients [32:00]</li> <li>Key Performance Indicators (KPIs) at GCP Research [45:20]</li> <li>How to get feedback to improve clinical trial conduct [52:05]</li> <li>Attending clinical research conference [56:28]</li> <li>Email vs. calling people and why picking up the phone makes a difference [59:55]</li> </ul> What was your favorite part of this interview? Let me know in the comments section below.

CTP 010: Effective Clinical Research Sites with Gabriel D'Amico-Mazza

James Hasegawa

“Don’t be afraid to try new things” - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you’re interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking  here and choosing “save as.” Selected Links from the Episode  Connect with James  LinkedIn  Medicare International Society for Pharmacoeconomics and Outcomes Research (IPSOR) BIO conference Stanford Biodesign Program Centre for Health Economics at University of York The National Institute for Health and Care Excellence (NICE) What is a MAC? Hospital Readmissions Reduction Program  Books Mentioned:  Leading at Mach 2 by Steve Sullivan Good to Great by Jim Collins The Tipping Point: How Little Things Can Make a Big Difference by Malcolm Gladwell Biodesign: The Process of Innovating Medical Technologies by Paul G. Yock and Stefanos Zenios Methods for the Economic Evaluation of Health Care Programmes (Oxford Medical Publications) by Michael F. Drummond,‎ Mark J. Sculpher,‎ Karl Claxton,‎ Greg L. Stoddart,‎ George W. Torrance  Show Notes:  What is Health Economics [01:52] James’s personal story: career path to HEOR [06:09] Daily routine of HEOR professionals [13:26] NICE and other HTA [14:30] HTA in the United States [15:15] HTA vs. MAC [16:30] The future of HEOR [18:59] Hospital Readmissions Reduction Program (HRRP) [19:58] Economic value and what should a medical product start-up do? [24:17] How to find HEOR consultants [25:00] Qualities of HEOR people [28:06] Health economic model: how to make one? [28:57] Working with Medicare Administrative Contractor (MAC) [31:38] The future of HEOR (continued) [33:20] On Big Data [34:57] Leveraging HEOR data in countries such as US and Japan [36:52] How does HTA function in the US [38:26] Resources and guidance documents on HTAs [40:23] HTA review process in Japan [43:30] Trick to learning other therapeutic areas [47:55]  What was most useful for you in this episode? Leave me a comment below and thanks for listening.

“Don’t be afraid to try new things” - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you’re interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. Listen to it on <a href="https://itunes.apple.com/us/podcast/clinical-trial-podcast-conversations-clinical-research/id1272290761?mt=2" rel="nofollow noopener" target="_blank">iTunes</a>.Stream by clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_005.mp3" rel="nofollow noopener" target="_blank">here</a>.Download as an MP3 by right-clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_005.mp3" rel="nofollow" target="_blank"> here</a> and choosing “save as.” Selected Links from the Episode <ul> <li>Connect with James</li> </ul> <a href="https://www.linkedin.com/in/james-hasegawa-b448b84/" rel="nofollow noopener" target="_blank">LinkedIn</a> <ul> <li><a href="https://www.medicare.gov/" rel="nofollow noopener" target="_blank">Medicare</a></li> <li><a href="https://www.ispor.org/" rel="nofollow noopener" target="_blank">International Society for Pharmacoeconomics and Outcomes Research (IPSOR)</a></li> <li><a href="http://convention.bio.org/" rel="nofollow noopener" target="_blank">BIO conference</a></li> <li><a href="http://biodesign.stanford.edu/" rel="nofollow noopener" target="_blank">Stanford Biodesign Program</a></li> <li><a href="https://www.york.ac.uk/che/" rel="nofollow noopener" target="_blank">Centre for Health Economics at University of York</a></li> <li><a href="https://www.nice.org.uk/" rel="nofollow noopener" target="_blank">The National Institute for Health and Care Excellence (NICE)</a></li> <li><a href="https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC.html" rel="nofollow noopener" target="_blank">What is a MAC?</a></li> <li><a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html" rel="nofollow noopener" target="_blank">Hospital Readmissions Reduction Program</a></li> </ul> Books Mentioned: <ul> <li><a href="https://www.amazon.com/Leading-at-Mach-Steve-Sullivan/dp/0964105314/ref=sr_1_1?ie=UTF8&amp;qid=1510438201&amp;sr=8-1&amp;keywords=leading+at+mach+2" rel="nofollow noopener" target="_blank">Leading at Mach 2</a> by Steve Sullivan</li> <li><a href="https://www.amazon.com/Good-Great-Some-Companies-Others/dp/0066620996/ref=sr_1_1?s=books&amp;ie=UTF8&amp;qid=1510439340&amp;sr=1-1&amp;keywords=good+to+great+jim+collins" rel="nofollow noopener" target="_blank">Good to Great</a> by Jim Collins</li> <li><a href="https://www.amazon.com/Tipping-Point-Little-Things-Difference/dp/0316346624/ref=sr_1_1?ie=UTF8&amp;qid=1510439496&amp;sr=8-1&amp;keywords=Tipping+Points" rel="nofollow noopener" target="_blank">The Tipping Point: How Little Things Can Make a Big Difference</a> by Malcolm Gladwell</li> <li><a href="https://www.amazon.com/Biodesign-Process-Innovating-Medical-Technologies/dp/110708735X/ref=sr_1_1?s=books&amp;ie=UTF8&amp;qid=1510439544&amp;sr=1-1&amp;keywords=biodesign" rel="nofollow noopener" target="_blank">Biodesign: The Process of Innovating Medical Technologies</a> by Paul G. Yock and Stefanos Zenios</li> <li><a href="https://www.amazon.com/Methods-Economic-Evaluation-Programmes-Publications/dp/0199665885/ref=sr_1_1?s=books&amp;ie=UTF8&amp;qid=1510441868&amp;sr=1-1&amp;keywords=methods+for+the+economic+evaluation+of+health+care+programmes" rel="nofollow noopener" target="_blank">Methods for the Economic Evaluation of Health Care Programmes (Oxford Medical Publications)</a> by Michael F. Drummond,‎ Mark J. Sculpher,‎ Karl Claxton,‎ Greg L. Stoddart,‎ George W. Torrance</li> </ul> Show Notes: <ul> <li>What is Health Economics [01:52]</li> <li>James’s personal story: career path to HEOR [06:09]</li> <li>Daily routine of HEOR professionals [13:26]</li> <li>NICE and other HTA [14:30]</li> <li>HTA in the United States [15:15]</li> <li>HTA vs. MAC [16:30]</li> <li>The future of HEOR [18:59]</li> <li>Hospital Readmissions Reduction Program (HRRP) [19:58]</li> <li>Economic value and what should a medical product start-up do? [24:17]</li> <li>How to find HEOR consultants [25:00]</li> <li>Qualities of HEOR people [28:06]</li> <li>Health economic model: how to make one? [28:57]</li> <li>Working with Medicare Administrative Contractor (MAC) [31:38]</li> <li>The future of HEOR (continued) [33:20]</li> <li>On Big Data [34:57]</li> <li>Leveraging HEOR data in countries such as US and Japan [36:52]</li> <li>How does HTA function in the US [38:26]</li> <li>Resources and guidance documents on HTAs [40:23]</li> <li>HTA review process in Japan [43:30]</li> <li>Trick to learning other therapeutic areas [47:55]</li> </ul> What was most useful for you in this episode? Leave me a comment below and thanks for listening.

CTP 005: Health Economics and Outcomes Research with James Hasegawa

In this episode, I had the opportunity to speak with Antoinette Frankum, who currently serves as the Vice President/Executive Director of Clinical Research at CROMSOURCE, a global Clinical Research Organization (CRO). Antoinette has over 20 years’ experience leading teams and managing complex clinical trials in the biopharma and medical device industry.  At CROMSOURCE, she is part of the executive team responsible for the US and international clinical operations.  Antoinette graduated from University of California, Los Angeles (UCLA), where she received her Bachelor's degree and executive management certificate. In this interview, Antoinette and I talk about what it takes to be a successful clinical project management professional. You will learn about effective ways to communicate with senior leadership, how to conduct a brainstorming session, the importance of a “Lessons Learned” document and much more. We wrap up on a very topic of growth versus fixed mindset.  My advance apologies for the poor sound quality in the first half the interview but the content is still audible (and valuable). Hope you enjoy this interview with the all amazing Antoinette (Torres) Frankum. Show Notes: Antoinette (Torres) Frankum on LinkedIn  Project Manager versus Program Manager: what is the difference?  Technical skill sets needed to become an effective clinical project management professional Creating and managing study timelines including tools such as Microsoft Gantt Understanding your stakeholders in clinical research  Investigators Patients Regulatory authority   Understanding your stakeholders in clinical research Managing patient expectations Managing resources and budget How to assess clinical trial risks as a CRO?  Feasibility  Identify what is going to impact timeline, budget, resources Quality issues   The right way to conduct a brainstorming session with your team Why you should conduct lessons learned during the close-out phase? Abundance thinking (growth mindset) versus scarcity thinking (fixed mindset) Helping your executive team by problem-solving Effective communication strategies with senior leadership Sites and CROs are on the same team It is okay to make mistakes Communication and people skills will help you grow faster Asking for feedback and ways to improve as a clinical research professional  Books Mentioned: Mindset: The New Psychology of Success by Carol S. Dweck The Gifts of Imperfection: Let Go of Who You Think You're Supposed to Be and Embrace Who You Are by Brené Brown Rising Strong: How the Ability to Reset Transforms the Way We Live, Love, Parent, and Lead by Brené Brown

In this episode, I had the opportunity to speak with Antoinette Frankum, who currently serves as the Vice President/Executive Director of Clinical Research at CROMSOURCE, a global Clinical Research Organization (CRO). Antoinette has over 20 years’ experience leading teams and managing complex clinical trials in the biopharma and medical device industry.  At CROMSOURCE, she is part of the executive team responsible for the US and international clinical operations.  Antoinette graduated from University of California, Los Angeles (UCLA), where she received her Bachelor's degree and executive management certificate. In this interview, Antoinette and I talk about what it takes to be a successful clinical project management professional. You will learn about effective ways to communicate with senior leadership, how to conduct a brainstorming session, the importance of a “Lessons Learned” document and much more. We wrap up on a very topic of growth versus fixed mindset.  My advance apologies for the poor sound quality in the first half the interview but the content is still audible (and valuable). Hope you enjoy this interview with the all amazing Antoinette (Torres) Frankum. Show Notes: Antoinette (Torres) Frankum on <a href="https://www.linkedin.com/in/antoinettetorresfrankum/" rel="nofollow noopener noreferrer" target="_blank">LinkedIn</a> <ul> <li>Project Manager versus Program Manager: what is the difference? </li> <li>Technical skill sets needed to become an effective clinical project management professional</li> <li>Creating and managing study timelines including tools such as Microsoft Gantt</li> <li>Understanding your stakeholders in clinical research <ul> <li>Investigators</li> <li>Patients</li> <li>Regulatory authority</li> </ul> </li> <li>Understanding your stakeholders in clinical research</li> <li>Managing patient expectations</li> <li>Managing resources and budget</li> <li>How to assess clinical trial risks as a CRO? <ul> <li>Feasibility </li> <li>Identify what is going to impact timeline, budget, resources</li> <li>Quality issues</li> </ul> </li> <li>The right way to conduct a brainstorming session with your team</li> <li>Why you should conduct lessons learned during the close-out phase?</li> <li>Abundance thinking (growth mindset) versus scarcity thinking (fixed mindset)</li> <li>Helping your executive team by problem-solving</li> <li>Effective communication strategies with senior leadership</li> <li>Sites and CROs are on the same team</li> <li>It is okay to make mistakes</li> <li>Communication and people skills will help you grow faster</li> <li>Asking for feedback and ways to improve as a clinical research professional</li> </ul> Books Mentioned: <a href="https://www.amazon.com/Mindset-Psychology-Carol-S-Dweck-ebook/dp/B000FCKPHG/ref=sr_1_2?crid=23TQNLSAS36QY&amp;keywords=carol+dweck&amp;qid=1562557197&amp;s=digital-text&amp;sprefix=carol+dw%2Cdigital-text%2C222&amp;sr=1-2" rel="nofollow noopener noreferrer" target="_blank">Mindset: The New Psychology of Success</a> by Carol S. Dweck <a href="https://www.amazon.com/Bren%C3%A9-Brown/e/B001JP45BA/ref=dp_byline_cont_book_1" rel="nofollow noopener noreferrer" target="_blank">The Gifts of Imperfection: Let Go of Who You Think You're Supposed to Be and Embrace Who You Are</a> by Brené Brown <a href="https://www.amazon.com/Rising-Strong-Ability-Transforms-Parent/dp/081298580X/ref=sr_1_7?crid=TZJQVHXXD5ZG&amp;keywords=brene+brown&amp;qid=1562557111&amp;s=books&amp;sprefix=bren%2Caps%2C214&amp;sr=1-7" rel="nofollow noopener noreferrer" target="_blank">Rising Strong: How the Ability to Reset Transforms the Way We Live, Love, Parent, and Lead</a> by Brené Brown

CTP 022: Clinical Project Management with Antoinette (Torres) Frankum

Ryan Jones

“Just create output. You don't start riding a bike until you take both feet off the ground and push off” - Ryan Jones, CEO, Florence Healthcare Technology is disrupting the clinical research industry. Globally sites, sponsors and CROs are adopting technology to manage risks, to stay competitive, to build a culture that embraces change, to fail fast and to move forward with speed.   In this interview with Ryan Jones, the CEO and Co-founder of Florence Healthcare, we discuss a wide range of topics including how technology is solving some of the biggest problems in clinical trial management, cold calling potential employers, and what it takes to build a healthcare startup. Ryan and his team at Florence have created a beautiful and practical e-source and e-regulatory product that eliminates inefficient clinical workflows. If you’re a clinical trial site, you should definitely check out Florence Healthcare technology solutions for clinical research. Ryan started his career at BCG Global Management Consulting and then became Product Manager for Microsoft Sharepoint. Before founding Florence, Ryan was President of Pubget, which had 600 medical centers and 6 of the 10 largest pharmas as customers. Ryan is a graduate from University of California-Berkeley and Dartmouth College. I hope you enjoy this fun and value-packed conversation with the all-amazing Ryan Jones.About This Podcast EpisodeListen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.”This episode is brought to you by CBI Events CBI has put together an Global Risk Based Monitoring event for clinical research professionals such as yourself. CBIs Global Risk Based Monitoring event is back for its third year to bring together thought leaders from around the world to benchmark, share best practices, evaluate technologies, overcome operational hurdles and make the most out of RBM. Attend this year’s event to gain best practices in protocol design, receive hands-on demonstrations of new technologies that you cannot learn in an RBM webinar, benchmark face-to-face with peers, develop new strategies in algorithm design and prepare for the future of RBM.Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners. Selected Links from the Episode Connect with Ryan on LinkedIn Ryan’s company Florence Healthcare Emory Healthcare National Cancer Institute Dana Farber Winship ACRPs’ Fundamentals of Clinical Research course Books Zero to One by Peter Thiel Joy, Inc.: How We Built a Workplace People Love by Richard Sheridan Show Notes Building something from nothing when you start a technology company [04:42] Left Microsoft after meeting a physician who was at Harvard [05:17] Hanging around Emory, met a physician who had a problem with task management and workflows and document management [07:32] What is e-regulatory? [08:04] Majority of that software investment is being made by pharma, CRO and device manufacturers for the people that work within their four walls [08:29] Research is done with spreadsheets and three-ring binders today [09:05] Write down the data once and have that data flow efficiently to the Sponsor and FDA [11:28] Two schools of thought in the world of technology for clinical trials [12:11] The history of clinical research since the 1970’s and evolution of change - FDA regulations, Institutional Review Boards (IRB), CRO (Clinical Research Organization), EDC (Electronic Data Capture), and now e-source and e-regulatory [14:52] Five territories - risk management, competition, culture, speed and scale  [18:12] Does the cost of technology offset any savings? [21:33] Best practices for evaluating and adopting new technology in clinical research (a) good checklist (b) internal champion (c) hypothesis of a better world after implementing the technology (d) tiger team to evaluate the software (e) return on investment [23:48] Protocols are getting more complex, work load has doubled, sites are consolidating and sponsors are getting sophisticated with digital tools [26:38] Paying for clinical technology and what’s in for the sponsor or CRO [29:35] Dream team [35:26] You can get a job in clinical research If you don't have the clinical research DNA, but have building DNA or doing DNA [41:26] Cold calling [43:09] Spending time with customers [50:29] Discovering clinical jobs in technology sector [53:12]QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

“Just create output. You don't start riding a bike until you take both feet off the ground and push off” - Ryan Jones, CEO, Florence Healthcare Technology is disrupting the clinical research industry. Globally sites, sponsors and CROs are adopting technology to manage risks, to stay competitive, to build a culture that embraces change, to fail fast and to move forward with speed.   In this interview with Ryan Jones, the CEO and Co-founder of Florence Healthcare, we discuss a wide range of topics including how technology is solving some of the biggest problems in clinical trial management, cold calling potential employers, and what it takes to build a healthcare startup. Ryan and his team at Florence have created a beautiful and practical e-source and e-regulatory product that eliminates inefficient clinical workflows. If you’re a clinical trial site, you should definitely check out Florence Healthcare technology solutions for clinical research. Ryan started his career at BCG Global Management Consulting and then became Product Manager for Microsoft Sharepoint. Before founding Florence, Ryan was President of Pubget, which had 600 medical centers and 6 of the 10 largest pharmas as customers. Ryan is a graduate from University of California-Berkeley and Dartmouth College. I hope you enjoy this fun and value-packed conversation with the all-amazing Ryan Jones.About This Podcast EpisodeListen to it on <a href="http://clinicaltrialpodcast.com/itunes" rel="noopener nofollow" target="_blank">iTunes</a>.Stream by clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_012.mp3" rel="nofollow noopener" target="_blank">here</a>.Download as an MP3 by right-clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_012.mp3" rel="nofollow noopener" target="_blank">here</a> and choosing “save as.”This episode is brought to you by CBI Events CBI has put together an <a href="http://www.cbinet.com/conference/pc18266" rel="nofollow noopener" target="_blank">Global Risk Based Monitoring</a> event for clinical research professionals such as yourself. CBIs Global Risk Based Monitoring event is back for its third year to bring together thought leaders from around the world to benchmark, share best practices, evaluate technologies, overcome operational hurdles and make the most out of RBM. Attend this year’s event to gain best practices in protocol design, receive hands-on demonstrations of new technologies that you cannot learn in an RBM webinar, benchmark face-to-face with peers, develop new strategies in algorithm design and prepare for the future of RBM.<a href="http://cbinet.com/rbmglobal" rel="nofollow noopener" target="_blank">Register today</a> to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners. Selected Links from the Episode Connect with Ryan on <a href="https://www.linkedin.com/in/adventurejones/" rel="nofollow noopener" target="_blank">LinkedIn</a> Ryan’s company <a href="https://www.florencehc.com/" rel="noopener nofollow" target="_blank">Florence Healthcare</a> <a href="https://www.emoryhealthcare.org/" rel="nofollow noopener" target="_blank">Emory Healthcare</a> <a href="https://www.cancer.gov/" rel="nofollow noopener" target="_blank">National Cancer Institute</a> <a href="http://www.dana-farber.org/" rel="nofollow noopener" target="_blank">Dana Farber</a> <a href="https://winshipcancer.emory.edu/" rel="nofollow noopener" target="_blank">Winship</a> ACRPs’ <a href="https://www.acrpnet.org/courses/fundamentals-clinical-research/" rel="nofollow noopener" target="_blank">Fundamentals of Clinical Research</a> course Books <a href="https://amzn.to/2KvmJAd" rel="nofollow noopener" target="_blank">Zero to One</a> by Peter Thiel <a href="https://amzn.to/2N7aICN" rel="nofollow noopener" target="_blank">Joy, Inc.: How We Built a Workplace People Love</a> by Richard Sheridan Show Notes Building something from nothing when you start a technology company [04:42] Left Microsoft after meeting a physician who was at Harvard [05:17] Hanging around Emory, met a physician who had a problem with task management and workflows and document management [07:32] What is e-regulatory? [08:04] Majority of that software investment is being made by pharma, CRO and device manufacturers for the people that work within their four walls [08:29] Research is done with spreadsheets and three-ring binders today [09:05] Write down the data once and have that data flow efficiently to the Sponsor and FDA [11:28] Two schools of thought in the world of technology for clinical trials [12:11] The history of clinical research since the 1970’s and evolution of change - FDA regulations, Institutional Review Boards (IRB), CRO (Clinical Research Organization), EDC (Electronic Data Capture), and now e-source and e-regulatory [14:52] Five territories - risk management, competition, culture, speed and scale  [18:12] Does the cost of technology offset any savings? [21:33] Best practices for evaluating and adopting new technology in clinical research (a) good checklist (b) internal champion (c) hypothesis of a better world after implementing the technology (d) tiger team to evaluate the software (e) return on investment [23:48] Protocols are getting more complex, work load has doubled, sites are consolidating and sponsors are getting sophisticated with digital tools [26:38] Paying for clinical technology and what’s in for the sponsor or CRO [29:35] Dream team [35:26] You can get a job in clinical research If you don't have the clinical research DNA, but have building DNA or doing DNA [41:26] Cold calling [43:09] Spending time with customers [50:29] Discovering clinical jobs in technology sector [53:12]QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

CTP 012: Solving Clinical Research Problems Using Technology with Ryan Jones

Mike Novotny

Today we’re in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world.  In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials.  Mike is the founder and CEO of Medrio. Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision.  Prior to founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the U.N. and a manager of the fraud database at VISA.  He holds a BA from Stanford University and an MBA from Columbia University. Mike founded Medrio in 2005 in San Francisco. I hope you enjoy my conversation with Mike.  What is a decentralized or virtual clinical trial?  Benefits of a virtual clinical trial in patient recruitment The current model of clinical trials where recruitment is done through the doctor What does it mean to conduct a decentralized or virtual clinical trial? Case Study - CNS trials and how they can benefit from going virtual  A limited number of patients (smaller patient pool)  Use of social media to find eligible patients The patient does not need to travel to the doctor’s office, the caregiver goes to the patients home   Medrio as a technology provider for virtual studies   eConsent Electronic data capture (EDC) Direct Data Capture (DDC) Randomization with EDC    Case Study - Cholera vaccine study in Yemen  Collecting clinical data without an internet connection The downside of paper data collection   DDC is a subset of eSource eSource can be EHR, DDC, ePRO, eCOA Future of EDC as we get more integrated with EHR Patient recruitment  New efforts through AI Efforts through social media Genetic profiling   Enabling participants to be anywhere in the world to participate in the trial Barriers to adoption Importance of monitoring in a virtual clinical trial to prevent fraud  The downside of a virtual clinical trial is the implementation  Patients want their doctor to be involved New tools lead to new complications The trial does not match the decentralized model   Common concerns from Sponsors  Storing data on the cloud is risky Offline data management - what if the wifi goes down or there is no cellular signal Data loss - what if the tablet break   Thinking in terms of relative risk Clinical trials fail 90% of the time Trial data is never looked at again Need to standardize audits to bring the cost down and improving the quality of the audit Medrio is focused on:   Speed Great tool for early phase diagnostic and device studies Customer service measured using net promoter scores eSource - Direct Data Capture (DDC)   Optimism, focusing on the positive, not watching/ reading the news 

Today we’re in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world.  In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials.  Mike is the founder and CEO of <a href="https://medrio.com/" rel="nofollow" target="_blank">Medrio</a>. Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision.  Prior to founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the U.N. and a manager of the fraud database at VISA.  He holds a BA from Stanford University and an MBA from Columbia University. Mike founded Medrio in 2005 in San Francisco. I hope you enjoy my conversation with Mike. <ul> <li>What is a decentralized or virtual clinical trial? </li> <li>Benefits of a virtual clinical trial in patient recruitment</li> <li>The current model of clinical trials where recruitment is done through the doctor</li> <li>What does it mean to conduct a decentralized or virtual clinical trial?</li> <li>Case Study - CNS trials and how they can benefit from going virtual <ul> <li>A limited number of patients (smaller patient pool) </li> <li>Use of social media to find eligible patients</li> <li>The patient does not need to travel to the doctor’s office, the caregiver goes to the patients home</li> </ul> </li> <li>Medrio as a technology provider for virtual studies  <ul> <li>eConsent</li> <li>Electronic data capture (EDC)</li> <li>Direct Data Capture (DDC)</li> <li>Randomization with EDC </li> </ul> </li> <li>Case Study - Cholera vaccine study in Yemen <ul> <li>Collecting clinical data without an internet connection</li> <li>The downside of paper data collection</li> </ul> </li> <li>DDC is a subset of eSource</li> <li>eSource can be EHR, DDC, ePRO, eCOA</li> <li>Future of EDC as we get more integrated with EHR</li> <li>Patient recruitment <ul> <li>New efforts through AI</li> <li>Efforts through social media</li> <li>Genetic profiling</li> </ul> </li> <li>Enabling participants to be anywhere in the world to participate in the trial</li> <li>Barriers to adoption</li> <li>Importance of monitoring in a virtual clinical trial to prevent fraud </li> <li>The downside of a virtual clinical trial is the implementation <ul> <li>Patients want their doctor to be involved</li> <li>New tools lead to new complications</li> <li>The trial does not match the decentralized model</li> </ul> </li> <li>Common concerns from Sponsors <ul> <li>Storing data on the cloud is risky</li> <li>Offline data management - what if the wifi goes down or there is no cellular signal</li> <li>Data loss - what if the tablet break</li> </ul> </li> <li>Thinking in terms of relative risk</li> <li>Clinical trials fail 90% of the time</li> <li>Trial data is never looked at again</li> <li>Need to standardize audits to bring the cost down and improving the quality of the audit</li> <li>Medrio is focused on:  <ul> <li>Speed</li> <li>Great tool for early phase diagnostic and device studies</li> <li>Customer service measured using net promoter scores</li> <li>eSource - Direct Data Capture (DDC)</li> </ul> </li> <li>Optimism, focusing on the positive, not watching/ reading the news</li> </ul>

Virtual Clinical Trials with Mike Novotny

Manuel Prado

“We’re at the threshold of an astounding period in medical discovery” - Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data.  Manuel and I had an amazing conversation about how we’re missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address issues with clinical data sources. We also talked about life philosophy, clinical resources that can take your career to a different level and the pace of change in the life sciences industry. Hope you enjoy my interview with the all amazing Manuel Prado. About Manuel Prado Spending much of his youth in Lima, Peru, Manuel Prado attended Southern Methodist University before beginning his career in investment banking. When presented with an opportunity to take a year’s sabbatical to travel the globe, he took it, meeting his now-wife in Thailand before returning to his California home. Inspired by his cultural journey, Prado soon founded the first of his three companies, VIVA Transcription Corporation, which developed patent-pending technology that brought the company national brand presence in the field of medical transcription, serving over 7,000 physicians across all 50 states and employing more than 400 people globally.In 2010, Manuel Prado began to transition away from the daily management of VIVA and founded RealHealthData, which provides real-world healthcare insights derived from medical transcription documents. With virtually real-time data coming from over 100,000 physicians across the country from every possible specialty, RealHealthData boasts a client list which includes many of the largest pharmaceutical companies in the world. Prado is also the founder of Adhearx, a company that collects data from automated phone calls to patients, which reveal the true causes of medication non-adherence. About This Podcast Episode Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode  Connect with Manuel Prado on LinkedIn The Center for Information and Study on Clinical Research Participation  (CISCRP) The New England Journal of Medicine Kevin Kelly &amp; The Inevitable Brene Brown 750 Words 5 Minute Journal Fierce Pharma Fierce CRO Fierce Biotech Fierce Medtech Center Watch Modern Medicine PM360 Pharmaceutical Executive Real Health Data Adhearx  Show Notes:  Manuel’s journey into clinical research [01:48] Medical transcription and the problem RealHealthData is trying to solve [05:34] Analyzing claims and EMR data and how it’s impacting recruitment in clinical trials [08:57] What physicians are looking at when making referrals to specialists  [10:54]How clinical data companies can engage with sponsors [19:00] FDA and real-world data [27:52] Impact of real-world data on clinical roles [30:09] The pace of change in life science industry [35:52] Why you should consider journaling [43:17] Sabbatical and surfing [48:17] Passion and life philosophy  [53:17] Where is reliable data coming from and what clinical researchers should focus on [55:29] Morning routine, staying focused and not getting distracted  [59:17] Making mistakes and not failure [1:00:52] Two issues with data sources: Timeliness of data and data on female and minority participants [1:07:00]  QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

“We’re at the threshold of an astounding period in medical discovery” - Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data.  Manuel and I had an amazing conversation about how we’re missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address issues with clinical data sources. We also talked about life philosophy, clinical resources that can take your career to a different level and the pace of change in the life sciences industry. Hope you enjoy my interview with the all amazing Manuel Prado. About Manuel Prado Spending much of his youth in Lima, Peru, Manuel Prado attended Southern Methodist University before beginning his career in investment banking. When presented with an opportunity to take a year’s sabbatical to travel the globe, he took it, meeting his now-wife in Thailand before returning to his California home. Inspired by his cultural journey, Prado soon founded the first of his three companies, VIVA Transcription Corporation, which developed patent-pending technology that brought the company national brand presence in the field of medical transcription, serving over 7,000 physicians across all 50 states and employing more than 400 people <a href="http://globally.In" rel="nofollow" target="_blank">globally.In</a> 2010, Manuel Prado began to transition away from the daily management of VIVA and founded <a href="http://www.realhealthdata.com/" rel="nofollow noopener" target="_blank">RealHealthData</a>, which provides real-world healthcare insights derived from medical transcription documents. With virtually real-time data coming from over 100,000 physicians across the country from every possible specialty, RealHealthData boasts a client list which includes many of the largest pharmaceutical companies in the world. Prado is also the founder of <a href="http://adhearx.com/" rel="nofollow noopener" target="_blank">Adhearx</a>, a company that collects data from automated phone calls to patients, which reveal the true causes of medication non-adherence. About This Podcast Episode Listen to it on <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_009.mp3" rel="nofollow noopener" target="_blank">iTunes.</a>Stream by clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_009.mp3" rel="nofollow noopener" target="_blank">here</a>.Download as an MP3 by right-clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_009.mp3" rel="nofollow noopener" target="_blank">here</a> and choosing “save as.” Selected Links from the Episode <ul> <li>Connect with <a href="https://www.linkedin.com/in/manuel-prado-373a5b76/" rel="nofollow noopener" target="_blank">Manuel Prado on LinkedIn</a></li> <li><a href="https://www.ciscrp.org/" rel="nofollow noopener" target="_blank">The Center for Information and Study on Clinical Research Participation  (CISCRP)</a></li> <li><a href="http://www.nejm.org/" rel="nofollow noopener" target="_blank">The New England Journal of Medicine</a></li> <li><a href="http://kk.org/" rel="nofollow noopener" target="_blank">Kevin Kelly</a> &amp; <a href="https://www.amazon.com/Inevitable-Understanding-Technological-Forces-Future/dp/0143110373" rel="nofollow noopener" target="_blank">The Inevitable</a></li> <li><a href="https://brenebrown.com/" rel="nofollow noopener" target="_blank">Brene Brown</a></li> <li><a href="http://750words.com/" rel="nofollow noopener" target="_blank">750 Words</a></li> <li><a href="https://www.amazon.com/Five-Minute-Journal-Happier-Minutes/dp/0991846206" rel="nofollow noopener" target="_blank">5 Minute Journal</a></li> <li><a href="https://www.fiercepharma.com/" rel="nofollow noopener" target="_blank">Fierce Pharma</a></li> <li><a href="https://www.fiercebiotech.com/cro" rel="nofollow noopener" target="_blank">Fierce CRO</a></li> <li><a href="https://www.fiercebiotech.com/" rel="nofollow noopener" target="_blank">Fierce Biotech</a></li> <li><a href="https://www.fiercebiotech.com/medtech" rel="nofollow noopener" target="_blank">Fierce Medtech</a></li> <li><a href="https://www.centerwatch.com/" rel="nofollow noopener" target="_blank">Center Watch</a></li> <li><a href="http://www.modernmedicine.com/" rel="nofollow noopener" target="_blank">Modern Medicine</a></li> <li><a href="https://www.pm360online.com/" rel="nofollow noopener" target="_blank">PM360</a></li> <li><a href="http://www.pharmexec.com/" rel="nofollow noopener" target="_blank">Pharmaceutical Executive</a></li> <li><a href="http://www.realhealthdata.com/" rel="nofollow noopener" target="_blank">Real Health Data</a></li> <li><a href="http://adhearx.com/" rel="nofollow noopener" target="_blank">Adhearx</a></li> </ul> Show Notes: <ul> <li>Manuel’s journey into clinical research [01:48]</li> <li>Medical transcription and the problem RealHealthData is trying to solve [05:34]</li> <li>Analyzing claims and EMR data and how it’s impacting recruitment in clinical trials [08:57]</li> <li>What physicians are looking at when making referrals to specialists  [10:54]How clinical data companies can engage with sponsors [19:00]</li> <li>FDA and real-world data [27:52]</li> <li>Impact of real-world data on clinical roles [30:09]</li> <li>The pace of change in life science industry [35:52]</li> <li>Why you should consider journaling [43:17]</li> <li>Sabbatical and surfing [48:17]</li> <li>Passion and life philosophy  [53:17]</li> <li>Where is reliable data coming from and what clinical researchers should focus on [55:29]</li> <li>Morning routine, staying focused and not getting distracted  [59:17]</li> <li>Making mistakes and not failure [1:00:52]</li> <li>Two issues with data sources: Timeliness of data and data on female and minority participants [1:07:00]</li> </ul> QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

CTP 009: Real World Data in Clinical Trials with Manuel Prado

Conversation with Clinical Development Veteran Marshall Cool “There are a lot of things we can do, but we want to make sure we’re doing what we want to do” - Marshall Cool In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be a clinical research veteran. Marshall brings to us his over two decades of clinical development experience, including his time at Abbott Vascular, leading one of the most exciting post-approval medical device studies, XIENCE V USA. Marshall also has significant experience managing Investigator Sponsored Studies (ISS) and clinical research organizations, details of which he shares with us during this interview. In addition, Marshall is an avid reader and loves books. Please enjoy my conversation with Marshall Cool. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode:  Connect with Marshall Cool  LinkedIn  CSU Annual Biotechnology Symposium Bristol-Myers Squibb Abbott Seth Godin Blog Center for Disease Control National Institute of Health Office of Inspector General Medical Affairs Strategic Summit (West) Medical Affairs Strategic Summit (East) ACRP Investigator Initiated and Sponsored Research Interest Group  Books Mentioned:  The Road to Character by David Brooks Chronicles of Narnia by C.S. Lewis and Pauline Baynes Linchpin: Are You Indispensable by Seth Godin The Checklist Manifesto: How to Get Things Right by Atul Gawande  Show Notes:  Description of what a clinical researcher does [02:10] Early days in clinical research [04:23] Roles and responsibilities of a clinical research associate (CRA) [08:55] You don’t need an M.D. or Ph.D. to be in clinical research [10:55] Relocating for jobs [13:20] Transition from pharma to medical device clinical trials [15:55] What to do when you lose your job [19:46] Getting into the habit of reading and how it can help your clinical research job [26:31] Getting to First Patient In (FPI) for a post-approval medical device study [31:50] Onboarding a clinical research organization (CRO) [39:15] Investigator sponsored studies (non-company sponsored research) [41:30] Starting your career in Phase I-III research [45:45] Marshall’s #1 advice to listeners [56:30] My motivations for starting the Clinical Trial Podcast [1:01:33]  QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.  

Conversation with Clinical Development Veteran Marshall Cool “There are a lot of things we can do, but we want to make sure we’re doing what we want to do” - Marshall Cool In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be a <a href="http://clinicaltrialpodcast.com/clinical-research/" rel="nofollow" target="_blank">clinical research</a> veteran. Marshall brings to us his over two decades of clinical development experience, including his time at Abbott Vascular, leading one of the most exciting post-approval medical device studies, XIENCE V USA. Marshall also has significant experience managing Investigator Sponsored Studies (ISS) and clinical research organizations, details of which he shares with us during this interview. In addition, Marshall is an avid reader and loves books. Please enjoy my conversation with Marshall Cool. Listen to it on <a href="https://itunes.apple.com/us/podcast/clinical-trial-podcast-conversations-clinical-research/id1272290761" rel="noopener nofollow" target="_blank">iTunes</a>.Stream by <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP003.mp3" rel="noopener nofollow" target="_blank">clicking here</a>.Download as an MP3 by <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP003.mp3" rel="nofollow" target="_blank">right-clicking here</a> and choosing “save as.” Selected Links from the Episode: <ul> <li>Connect with Marshall Cool</li> </ul> <a href="https://www.linkedin.com/in/marshall-cool-18aab024/" rel="noopener nofollow" target="_blank">LinkedIn</a> <ul> <li><a href="http://www.csuperb.org/symposium/" rel="nofollow noopener" target="_blank">CSU Annual Biotechnology Symposium</a></li> <li><a href="https://www.bms.com/" rel="nofollow noopener" target="_blank">Bristol-Myers Squibb</a></li> <li><a href="http://www.abbott.com/" rel="nofollow noopener" target="_blank">Abbott</a></li> <li><a href="http://sethgodin.typepad.com/" rel="nofollow noopener" target="_blank">Seth Godin Blog</a></li> <li><a href="https://www.cdc.gov/" rel="nofollow noopener" target="_blank">Center for Disease Control</a></li> <li><a href="https://www.nih.gov/" rel="nofollow noopener" target="_blank">National Institute of Health</a></li> <li><a href="https://oig.hhs.gov/" rel="nofollow noopener" target="_blank">Office of Inspector General</a></li> <li><a href="http://exl-mass.com/west" rel="nofollow noopener" target="_blank">Medical Affairs Strategic Summit (West)</a></li> <li><a href="http://exl-mass.com/east" rel="nofollow noopener" target="_blank">Medical Affairs Strategic Summit (East)</a></li> <li><a href="https://www.acrpnet.org/networking/interest-groups/" rel="nofollow noopener" target="_blank">ACRP Investigator Initiated and Sponsored Research Interest Group</a></li> </ul> Books Mentioned: <ul> <li><a href="http://amzn.to/2uTpojb" rel="nofollow" target="_blank">The Road to Character</a> by David Brooks</li> <li><a href="http://amzn.to/2vNSeAh" rel="nofollow" target="_blank">Chronicles of Narnia</a> by C.S. Lewis and Pauline Baynes</li> <li><a href="http://amzn.to/2vO0bWh" rel="nofollow" target="_blank">Linchpin: Are You Indispensable</a> by Seth Godin</li> <li><a href="http://amzn.to/2vSD3Ep" rel="nofollow" target="_blank">The Checklist Manifesto: How to Get Things Right</a> by Atul Gawande</li> </ul> Show Notes: <ul> <li>Description of what a clinical researcher does [02:10]</li> <li>Early days in clinical research [04:23]</li> <li>Roles and responsibilities of a clinical research associate (CRA) [08:55]</li> <li>You don’t need an M.D. or Ph.D. to be in clinical research [10:55]</li> <li>Relocating for jobs [13:20]</li> <li>Transition from pharma to medical device clinical trials [15:55]</li> <li>What to do when you lose your job [19:46]</li> <li>Getting into the habit of reading and how it can help your clinical research job [26:31]</li> <li>Getting to First Patient In (FPI) for a post-approval medical device study [31:50]</li> <li>Onboarding a clinical research organization (CRO) [39:15]</li> <li>Investigator sponsored studies (non-company sponsored research) [41:30]</li> <li>Starting your career in Phase I-III research [45:45]</li> <li>Marshall’s #1 advice to listeners [56:30]</li> <li>My motivations for starting the Clinical Trial Podcast [1:01:33]</li> </ul> QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

CTP 003: Conversation with Clinical Development Veteran Marshall Cool

Christina Mack

Christina Mack, Ph.D., MSPH is Sr. Director of Epidemiology and Clinical Evidence in the IQVIA Real-World Insights division. She is a recognized expert in effectiveness studies for medical devices and pharmaceutical products, sports injury research, and pharmacoepidemiology methods including the use of external comparators, propensity scores, instrumental variables, and missing data.   Her work focuses on the use of electronic health record systems and claims data for research, with a focus in study design methodology, maternal health, orthopedics, oncology, and infectious disease.   Dr. Mack oversees development of large evidence hubs and novel studies that augment primary data collection with existing data and leads the IQVIA Injury Surveillance and Analytics team which serves as the epidemiologic research arm of the NFL and NBA. She is an epidemiologist and computer engineer by training, with Ph.D. and master’s degrees from the University of North Carolina at Chapel Hill and an engineering degree from the University of Notre Dame.   Currently, Dr. Mack holds an academic appointment as Adjunct Assistant Professor of Epidemiology at the University of North Carolina at Chapel Hill and serves on the Advisory Board of the Carolina Health Informatics Program. Dr. Mack has published manuscripts in leading journals and authored several chapters in the Agency for Healthcare Research and Quality (AHRQ) landmark publication "Registries for Evaluating Patient Outcomes: A User's Guide" on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks.   She is a speaker at regulatory, governmental, and academic forums on epidemiologic methods and novel study designs as well as careers in research. Last but not the least, she has over fifteen years of scientific and technical experience working for Johnson &amp; Johnson, GlaxoSmithKline, IBM, and the World Health Organization in addition to her work at IQVIA. Her regulatory experience includes advising the FDA, most recently as faculty at the 2017 MDEpiNet Annual Meeting and at the FDA Cardiac Research Safety Consortium discussing novel research methods and use of electronic medical records for outcomes trials.   Please join me in welcoming Dr. Mack on the Clinical Trial Podcast. Resources and organizations mentioned in this episode: IQVIA Food and Drug Administration (FDA) Pubmed ClinicalTrials.Gov Norwegian Mother and Child Cohort Study (MoBa) Global Fund Clinton Foundation World Health Organization and HIV IBM Johnson and Johnson Organization of Eastern Caribbean Islands Outcomes Sciences MIT Harvard School of Public Health University of Lusaka Quintiles Healthcare Business Women's Association Agency for Healthcare Research and Quality (AHRQ) landmark publication “Registries for Evaluating Patient Outcomes: A User’s Guide” on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks American College of Cardiology National Cancer Institute  FDA's Sentinel Initiative NBA NFL MDEpinet University of North Carolina Chapel Hill New York Times People mentioned in this episode:  Manuel Prado Dr. Nancy Dreyer Dr. Mark Travis Rob Cahill

Christina Mack, Ph.D., MSPH is Sr. Director of Epidemiology and Clinical Evidence in the IQVIA Real-World Insights division. She is a recognized expert in effectiveness studies for medical devices and pharmaceutical products, sports injury research, and pharmacoepidemiology methods including the use of external comparators, propensity scores, instrumental variables, and missing data.   Her work focuses on the use of electronic health record systems and claims data for research, with a focus in study design methodology, maternal health, orthopedics, oncology, and infectious disease.   Dr. Mack oversees development of large evidence hubs and novel studies that augment primary data collection with existing data and leads the IQVIA Injury Surveillance and Analytics team which serves as the epidemiologic research arm of the NFL and NBA. She is an epidemiologist and computer engineer by training, with Ph.D. and master’s degrees from the University of North Carolina at Chapel Hill and an engineering degree from the University of Notre Dame.   Currently, Dr. Mack holds an academic appointment as Adjunct Assistant Professor of Epidemiology at the University of North Carolina at Chapel Hill and serves on the Advisory Board of the Carolina Health Informatics Program. Dr. Mack has published manuscripts in leading journals and authored several chapters in the Agency for Healthcare Research and Quality (AHRQ) landmark publication "Registries for Evaluating Patient Outcomes: A User's Guide" on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks.   She is a speaker at regulatory, governmental, and academic forums on epidemiologic methods and novel study designs as well as careers in research. Last but not the least, she has over fifteen years of scientific and technical experience working for Johnson &amp; Johnson, GlaxoSmithKline, IBM, and the World Health Organization in addition to her work at IQVIA. Her regulatory experience includes advising the FDA, most recently as faculty at the 2017 MDEpiNet Annual Meeting and at the FDA Cardiac Research Safety Consortium discussing novel research methods and use of electronic medical records for outcomes trials.   Please join me in welcoming Dr. Mack on the Clinical Trial Podcast. Resources and organizations mentioned in this episode: <a href="https://www.iqvia.com/" rel="nofollow" target="_blank">IQVIA</a> <a href="https://www.fda.gov/" rel="nofollow" target="_blank">Food and Drug Administration (FDA)</a> <a href="https://www.ncbi.nlm.nih.gov/pubmed/" rel="nofollow" target="_blank">Pubmed</a> <a href="https://clinicaltrials.gov/" rel="nofollow" target="_blank">ClinicalTrials.Gov</a> <a href="https://www.fhi.no/en/studies/moba/" rel="nofollow" target="_blank">Norwegian Mother and Child Cohort Study (MoBa)</a> <a href="https://www.theglobalfund.org/" rel="nofollow" target="_blank">Global Fund</a> <a href="https://www.clintonfoundation.org/" rel="nofollow" target="_blank">Clinton Foundation</a> <a href="http://www.who.int/" rel="nofollow" target="_blank">World Health Organization</a> and <a href="http://www.who.int/hiv/en/" rel="nofollow" target="_blank">HIV</a> <a href="https://www.ibm.com/" rel="nofollow" target="_blank">IBM</a> <a href="https://www.jnj.com/" rel="nofollow" target="_blank">Johnson and Johnson</a> <a href="https://www.oecs.org/" rel="nofollow" target="_blank">Organization of Eastern Caribbean Islands</a> <a href="http://www.h-outcomes.com/" rel="nofollow" target="_blank">Outcomes Sciences</a> <a href="https://www.mit.edu/" rel="nofollow" target="_blank">MIT</a> <a href="https://www.hsph.harvard.edu/" rel="nofollow" target="_blank">Harvard School of Public Health</a> <a href="http://www.unilus.ac.zm/" rel="nofollow" target="_blank">University of Lusaka</a> <a href="https://www.iqvia.com/" rel="nofollow" target="_blank">Quintiles</a> <a href="https://www.hbanet.org/" rel="nofollow" target="_blank">Healthcare Business Women's Association</a> <a href="https://www.ahrq.gov/" rel="nofollow" target="_blank">Agency for Healthcare Research and Quality (AHRQ)</a> landmark publication “<a href="https://www.ncbi.nlm.nih.gov/pubmed/24945055" rel="nofollow" target="_blank">Registries for Evaluating Patient Outcomes: A User’s Guide</a>” on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks <a href="https://www.acc.org/" rel="nofollow" target="_blank">American College of Cardiology</a> <a href="https://www.cancer.gov/" rel="nofollow" target="_blank">National Cancer Institute</a> <a href="https://www.fda.gov/safety/fdassentinelinitiative/ucm2007250.htm" rel="nofollow" target="_blank"> FDA's Sentinel Initiative</a> <a href="https://www.nba.com/" rel="nofollow" target="_blank">NBA</a> <a href="https://www.nfl.com/" rel="nofollow" target="_blank">NFL</a> <a href="http://mdepinet.org/" rel="nofollow" target="_blank">MDEpinet</a> <a href="https://www.unc.edu/" rel="nofollow" target="_blank">University of North Carolina Chapel Hill</a> <a href="https://www.nytimes.com/" rel="nofollow" target="_blank">New York Times</a> People mentioned in this episode: <a href="https://clinicaltrialpodcast.com/interview-manuel-prado/" rel="nofollow" target="_blank"> Manuel Prado</a> <a href="https://www.linkedin.com/in/nancy-a-dreyer-135b852/" rel="nofollow" target="_blank">Dr. Nancy Dreyer</a> Dr. Mark Travis Rob Cahill

CTP 015: Real-World Insights and Epidemiology with Dr. Christina Mack

Manfred Stapff

“It is important that you start with the big picture” - Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air Force. Manfred earned his MD and Ph.D. from the Ludwig Maximilian University of Munich. In this interview, Manfred shares his personal story as a general physician for pilots to an industry professional in clinical trials. Manfred also has exceptional advice for physicians looking to get into clinical research. To wrap up, we talk about his role as a liaison between medical science and clinical operations.   I hope you enjoy this interview with Dr. Manfred Stapff. Listen to it on  iTunes.Stream by clicking  here.Download as an MP3 by right-clicking  here and choosing “save as.” Selected Links from the Episode:  Connect with Manfred  LinkedIn  Lancet Drug Information Association (DIA) Association of Clinical Research Professionals (ACRP) Food and Drug Administration (FDA) Journal of Clinical Hypertension American Heart Association (AHA) New England Journal of Medicine (NJEM) TriNetX Merck Good Clinical Practice ICH  Show Notes:  About TriNetX [02:15] The changing landscape in protocol design [04:16] How TriNetX is helping scientist and health care organizations [06:57] What types of people are companies like TriNetX hiring [10:54] Transitioning from general physician for pilots to Merck [13:32] Advice for medical school students and graduates interested in clinical research [18:12] Working at CROs - what to expect [23:27] Why patient enrollment is challenging [25:29] Why should sites consider being part of networks such as TriNetX [28:11] How clinical (medical) and industry can be advantageous to you [31:08] Importance of doing the “dirty work” in clinical research [32:46] Importance of doing the “dirty work” in clinical research [32:46] Being open to other people’s opinions [36:30] Dealing with tension between science and clinical operations [28:43] Keeping yourself informed about new clinical treatments and scientific findings [46:41]  QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.

“It is important that you start with the big picture” - Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air Force. Manfred earned his MD and Ph.D. from the Ludwig Maximilian University of Munich. In this interview, Manfred shares his personal story as a general physician for pilots to an industry professional in clinical trials. Manfred also has exceptional advice for physicians looking to get into clinical research. To wrap up, we talk about his role as a liaison between medical science and clinical operations.   I hope you enjoy this interview with Dr. Manfred Stapff. Listen to it on <a href="https://itunes.apple.com/us/podcast/clinical-trial-podcast-conversations-clinical-research/id1272290761?mt=2" rel="nofollow" target="_blank"> iTunes</a>.Stream by clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_007.mp3" rel="nofollow" target="_blank"> here</a>.Download as an MP3 by right-clicking <a href="http://traffic.libsyn.com/clinicaltrialpodcast/CTP_007.mp3" rel="nofollow" target="_blank"> here</a> and choosing “save as.” Selected Links from the Episode: <ul> <li>Connect with Manfred</li> </ul> <a href="https://www.linkedin.com/in/manfredstapff/" rel="nofollow noopener" target="_blank">LinkedIn</a> <ul> <li><a href="http://www.thelancet.com/" rel="nofollow noopener" target="_blank">Lancet</a></li> <li><a href="http://www.diaglobal.org/" rel="nofollow noopener" target="_blank">Drug Information Association (DIA)</a></li> <li><a href="https://www.acrpnet.org/" rel="nofollow noopener" target="_blank">Association of Clinical Research Professionals (ACRP)</a></li> <li><a href="https://www.fda.gov/" rel="nofollow noopener" target="_blank">Food and Drug Administration (FDA)</a></li> <li><a href="http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1751-7176" rel="nofollow noopener" target="_blank">Journal of Clinical Hypertension</a></li> <li><a href="http://www.heart.org/" rel="nofollow noopener" target="_blank">American Heart Association (AHA)</a></li> <li><a href="http://www.nejm.org/" rel="nofollow noopener" target="_blank">New England Journal of Medicine (NJEM)</a></li> <li><a href="https://www.trinetx.com/" rel="nofollow noopener" target="_blank">TriNetX</a></li> <li><a href="https://www.merck.com/" rel="nofollow noopener" target="_blank">Merck</a></li> <li><a href="https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf" rel="nofollow noopener" target="_blank">Good Clinical Practice</a></li> <li><a href="http://www.ich.org/" rel="nofollow noopener" target="_blank">ICH</a></li> </ul> Show Notes: <ul> <li>About TriNetX [02:15]</li> <li>The changing landscape in protocol design [04:16]</li> <li>How TriNetX is helping scientist and health care organizations [06:57]</li> <li>What types of people are companies like TriNetX hiring [10:54]</li> <li>Transitioning from general physician for pilots to Merck [13:32]</li> <li>Advice for medical school students and graduates interested in clinical research [18:12]</li> <li>Working at CROs - what to expect [23:27]</li> <li>Why patient enrollment is challenging [25:29]</li> <li>Why should sites consider being part of networks such as TriNetX [28:11]</li> <li>How clinical (medical) and industry can be advantageous to you [31:08]</li> <li>Importance of doing the “dirty work” in clinical research [32:46]</li> <li>Importance of doing the “dirty work” in clinical research [32:46]</li> <li>Being open to other people’s opinions [36:30]</li> <li>Dealing with tension between science and clinical operations [28:43]</li> <li>Keeping yourself informed about new clinical treatments and scientific findings [46:41]</li> </ul> QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.

CTP 007: The Future with EMR with Dr. Manfred Stapff

In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research.  Throughout my career, I’ve always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand.  Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial sites in the region. We tackle a variety of topics including the regulatory framework, start-up process, and even the possibility of moving to beautiful New Zealand to learn and practice clinical trial management. I hope you enjoy this energetic interview with Richard Stubbs.  [Show Notes]  A surgeon by training, president of P3 Research, president of New Zealand Association of Clinical Research (NZ-ACR), a national organization New Zealand has the first world health system Investigator and industry-sponsored research in New Zealand  Ethics committee approval process  Organization’s mission is the education of clinical research site personnel (research coordinators, nurses, administrators) Conference every other year and then more frequent regional meetings Access to templates for contracts and indemnity documents, standardized for all sites across New Zealand, similar to MAGI template Schedule 6 in the contract allows sponsors to add additional verbiage in the contract Political activity encouraging the government to streamline the process for research (ex: New Zealand pavilion at BIO 2019) Provisional approved and what it means Medical device approval in New Zealand and how it’s different from drug approval Regulations in New Zealand for Clinical Research Reasons why New Zealand is a great location to conduct clinical research, especially for early phase studies    Intellectual property protection No IND needed Fair budget Quick data Quality data Other regulatory bodies trust the data   New Zealand is part of the Asia Pacific and Japan (APJ) region Site Selection in New Zealand    How to find sites What to consider   Regulatory approval and site start-up processes in New Zealand   Site start-up (gathering essential documents as governed by GCP) A centralized and electronic ethics approval process  Approval of the Ministry of health to allow the importation of the unregistered drug (SCOTT committee that replaces the IND)    Role of the ethics committee in participant reimbursement    Payment to patients generally diminishes with the increase in the phase of the study   Importance of embedding clinical research in clinical care Overhead costs at public and private hospitals in New Zealand Only make surplus money out of clinical research is the volume Thinking of clinical research in terms of value to patients and their staff Moving to New Zealand to start a career in clinical research. There is a need for professionals such as doctors and nurses. Value systems in New Zeland such as men and women equality  

In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research.  Throughout my career, I’ve always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand.  Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial sites in the region. We tackle a variety of topics including the regulatory framework, start-up process, and even the possibility of moving to beautiful New Zealand to learn and practice clinical trial management. I hope you enjoy this energetic interview with Richard Stubbs.  [Show Notes] <ul> <li>A surgeon by training, president of P3 Research, president of New Zealand Association of Clinical Research (NZ-ACR), a national organization</li> <li>New Zealand has the first world health system</li> <li>Investigator and industry-sponsored research in New Zealand </li> <li>Ethics committee approval process </li> <li>Organization’s mission is the education of clinical research site personnel (research coordinators, nurses, administrators)</li> <li>Conference every other year and then more frequent regional meetings</li> <li>Access to templates for contracts and indemnity documents, standardized for all sites across New Zealand, similar to MAGI template</li> <li>Schedule 6 in the contract allows sponsors to add additional verbiage in the contract</li> <li>Political activity encouraging the government to streamline the process for research (ex: New Zealand pavilion at BIO 2019)</li> <li>Provisional approved and what it means</li> <li>Medical device approval in New Zealand and how it’s different from drug approval</li> <li>Regulations in New Zealand for Clinical Research</li> <li>Reasons why New Zealand is a great location to conduct clinical research, especially for early phase studies </li> <li> <ul> <li>Intellectual property protection</li> <li>No IND needed</li> <li>Fair budget</li> <li>Quick data</li> <li>Quality data</li> <li>Other regulatory bodies trust the data</li> </ul> </li> <li>New Zealand is part of the Asia Pacific and Japan (APJ) region</li> <li>Site Selection in New Zealand </li> <li> <ul> <li>How to find sites</li> <li>What to consider</li> </ul> </li> <li>Regulatory approval and site start-up processes in New Zealand</li> <li> <ul> <li>Site start-up (gathering essential documents as governed by GCP)</li> <li>A centralized and electronic ethics approval process </li> <li>Approval of the Ministry of health to allow the importation of the unregistered drug (SCOTT committee that replaces the IND) </li> </ul> </li> <li>Role of the ethics committee in participant reimbursement </li> <li> <ul> <li>Payment to patients generally diminishes with the increase in the phase of the study</li> </ul> </li> <li>Importance of embedding clinical research in clinical care</li> <li>Overhead costs at public and private hospitals in New Zealand</li> <li>Only make surplus money out of clinical research is the volume</li> <li>Thinking of clinical research in terms of value to patients and their staff</li> <li>Moving to New Zealand to start a career in clinical research. There is a need for professionals such as doctors and nurses.</li> <li>Value systems in New Zeland such as men and women equality </li> </ul>

CTP 023: Clinical Research In New Zealand

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