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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
26
46
min

The CRO TMF Handoff: The solution to hidden compliance gaps in CRO to sponsor TMF transfers

The end-of-study TMF transfer shouldn't be a black box. But for too many sponsors it is, until they're staring down a list of inspection findings.

In this episode, Paul Carter and Christina Mantzioros share tried and tested ways to identify TMF problems before your CRO sends the final package, and how AI-powered risk models can help you verify completeness and quality without manually checking thousands of documents.

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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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