Clinical Trial Podcast | Conversations with Clinical Research Experts – Détails, épisodes et analyse

To get more insights about clinical research technology from a vendor's perspective, I invited Mike Wenger on the Clinical Trial Podcast.

Mike Wenger is a software developer with over 15 years of experience creating innovative solutions in clinical research. 

At the Michael J. Fox Foundation for Parkinson's Research, he worked to connect Parkinson's patients with clinical studies. 

He later developed Citeline Connect, bridging patient recruitment companies with pharmaceutical organizations, and founded VersaTrial to streamline clinical trial site workflows. 

Mike is currently the Chief Innovation Officer at CRIO, an intuitive eSource solution that collects data directly at the point of patient interaction to lighten site burden while driving protocol compliance.

Please join me in welcoming Mike on the Clinical Trial Podcast.

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 37,000 study sites, sponsors, and CROs in 90 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/

Her vast experiences dealing with small to large pharmaceutical companies, academic centers, regulatory agencies, clinical research organizations, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance.  

Donna has presented training programs in topics of GCP compliance, Quality Management Systems, Inspection Readiness, and Trial Master File (TMF) Management.

She is the Lead Editor in the newest edition of Good Clinical Practice: A Question and Answer Guide 2024/2025, is a member of the TMF Reference Model Steering Committee, and was recently named an Ernst & Young Entrepreneur of the Year.  

Donna earned a Bachelor of Science in Nursing from Gwynedd Mercy University where she is currently serving as a member of the Board of Trustees and a Master of Science in Nursing from Widener University. 

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 37,000 study sites, sponsors, and CROs in 90 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 & 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. 

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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/

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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 & Co-Founder at uMotif.

Please join me in welcoming Bruce and Ben on the Clinical Trial Podcast.

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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 

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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. 

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. 

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/

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.

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