I'm the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. My goal is to interview leading experts in clinical trial management to help you accelerate your career and be a more effective leader. I enjoy connecting like-minded people, introducing new ideas, and immersing myself in an environment of continuous learning. I invite you to sign up for my weekly newsletter where I share useful and important clinical trail related insights.
Risk Management for Clinical Investigators with Bijan Elahi
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Hi Reader A lot of of what happens in medical product development is managing risks. There is risk in every step of the medical product development lifecycle. Our guest today is Bijan Elahi, where we talk about risk management for clinical investigators conducting medical device clinical trials. In this episode, 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. 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 also the author of Safety Risk Management for Medical Devices, a book on essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. I hope you enjoy my conversation with Bijan on the Clinical Trial Podcast. Love, Kunal
Quote I'm pondering"In the end, it all comes down to how often you were kind and compassionate, genuinely so, even in the most difficult and trying of circumstances." — Neil Strauss (@NeilStrauss) A tweet that I found insightfulAmerican Billionaire Bill Ackman (@BillAckman) provides an important perspective on vaccine development and the incentives for drug manufacturers.
Career OpportunitiesThe following organizations are hiring for clinical and non-clinical roles. If you’re interested in advancing your career & meet most of the job requirements, consider applying for the role.
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Hi! I'm a Kunal,
I'm the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. My goal is to interview leading experts in clinical trial management to help you accelerate your career and be a more effective leader. I enjoy connecting like-minded people, introducing new ideas, and immersing myself in an environment of continuous learning. I invite you to sign up for my weekly newsletter where I share useful and important clinical trail related insights.
Hi Reader In this episode, I’m excited to share with you my interview with Dr. Alison Bateman-House discussing Access to Novel Medical Products Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike. To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor in the Division of Medical Ethics at NYU Grossman School of Medicine. Dr....
Hi Reader In this episode, I’m excited to share with you my interview with Erike Stevens discussing Clinical Research as a Profession. Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either. To explore the topic of clinical research as a profession, I invited Erika Stevens on the podcast. Erika...
Hi Reader If you’re a new subscriber, welcome! My name is Kunal Sampat, and I host the Clinical Trial Podcast. I also write blog posts on clinical research and am committed to sharing everything I know about clinical trials with you. If you’ve been on my email list for a while, thank you for your patience. My email updates have been less frequent than I’d like, but I’m excited to be back with regular content. In this episode, I’m excited to share an interview with Chris Komelasky on Community...