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The State of TMF Podcast

We sit down with the most interesting and intelligent players in the life sciences industry.  

episode
24
45
min

ICH E6(R3): The Birth of the (Digital) Record

In this episode, our experts will be diving into ICH E6(R3) and the shift from documents to truly digital, regulatory-compliant records. Clinical trial management is evolving, and this discussion will explore what that means for the future.

Joining us for this conversation is our President & CEO, Paul Fenton-Carter, , alongside Karen Roy from Epista and Joanne Malia from Regeneron. Together, they’ll discuss what we know about ICH E6(R3) now, what's to come in the future, and how this shift will impact the industry.

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About the show

Welcome to the State of TMF podcast. On this podcast, you'll learn how to take your TMF process and strategy to the next level. From providing insights on how to improve inspection readiness to identifying and scaling optimization programs that work, to training your team to operate at scale - you will understand what is takes to create a world class TMF program. Through interviews, AMA's, and invite-only events, we give you a sneak peek into the data-backed insights we are executing for TMF teams across the globe.

Our hosts

Paul Carter

Paul Carter has over 25 years of experience developing and validating computerized systems for regulated clinical trials across the EU and North America. As CEO of Montrium, he leads the vision for the Connect platform. He chairs the CDISC eTMF Standards working group and is a longstanding member of the TMF Reference Model Steering Committee.

Christina Mantzioros

Christina Mantzioros brings over a decade of experience in clinical research and technology. As Head of Clinical Solutions Strategy at Montrium, she shapes the next generation of the eTMF platform, translating clinical and regulatory needs into practical product solutions. She is the co-host of The State of TMF podcast and a regular speaker at industry events including the CDISC TMF Interchange.

We are back with season 4!

The State of TMF Podcast

Season 4 covers the TMF issues surfacing in inspections and raising questions at the leadership level. The topics your team is dealing with right now.

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