WE'RE 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.

Each episode is led by Paul Carter, Founder and CEO of Montrium and Chair of the CDISC TMF Reference Model Steering Committee, and Christina Mantzirios, Head of Clinical Solutions Strategy, they bring nearly 40 years of combined experience to topics like ICH E6 R3, AI in oversight, and inspection readiness.



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SEASON 4

Season 4

Check out what's in store this season!

The State of TMF episodes will be revealed every month.

SOTMF - Season 4 - Episode 1

Episode 1 - The CRO TMF Handoff: The solution to hidden compliance gaps in CRO to sponsor TMF transfers

Episode will be aired on March 24th, 2026 @ 11AM EDT

The end-of-study TMF transfer catches too many sponsors off guard, and inspection findings are often the first sign something went wrong.

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

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State of TMF - Season 4 Episode 2

Episode 2 - Coming soon

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State of TMF - Season 4 Episode 3

Episode 3 - Coming soon

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Your hosts

The State of TMF is hosted by experienced TMF'ers from Montrium.

  • Paul Carter

    Paul Carter

    President & CEO

    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

    Head of Clinical Solutions Strategy

    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.

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JOIN THE COMMUNITY

Built for TMF professionals, by TMF professionals.

One hour a month with the State of TMF Podcast gives you practical insights that make your day-to-day work easier, faster, and more compliant.

Strengthen your inspection readiness knowledge

Learn how to spot compliance gaps early, reduce findings, and ensure your TMF is inspection-ready.

Stay current on what's changing in TMF

Get actionable guidance on AI in oversight, Quality by Design, record retention, and end-of-study handoffs.

Connect with 1,000+ TMF professionals

Join peers and experts facing the same challenges, sharing insights, and learning together.

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Win a custom State of TMF hoodie or crewneck sweater 🔥

Every episode, one attendee wins a custom "TMF'er for Life" sweatshirt. Show up live and you're automatically in the draw. The winner chooses between a gray hoodie or a black crewneck.

Good luck! 🍀

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Register for the upcoming episodes

Join us once a month!

The State of TMF is a monthly podcast event where you get practical, actionable knowledge and direct access to our hosts. Register and ask your questions live and join the conversation.

 

Join a community of 1,000+ TMF professionals

Share ideas, ask questions, and join the conversation.

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State of TMF Community

Frequently asked questions

Is each session recorded?

Yes. All sessions are recorded and made available on YouTube and all major podcast platforms.

Can I get access to the slide deck?

Of course. Slides from each of our presentations are available exclusively within the State of TMF LinkedIn Community Group. You can find it here.

How can I attend the podcast?

Save your seat to the podcast by completing the short form above. You'll receive details on how to join each episode via email a few weeks before the event.

Do I need to register for every event individually?

No. Once you've registered for State of TMF, you're signed up for every session we hold. If you've saved your seat already, look out for email comms prior to the podcast episode with details on how to join.

Can I be a guest speaker on The State of TMF?

Yes, we welcome speaker suggestions. If you're interested in speaking or want to recommend a guest please email marketing@montrium.com.

What is the State of TMF Community group?

The State of TMF Community group is a private LinkedIn group for TMF professionals. Members get access to exclusive content, slide decks, and resources from each episode. Join to share experiences, ask questions, stay updated on industry events, and connect with peers. You can find it here.

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