--- title: The State of TMF Podcast description: The State of TMF Podcast Shares insights on TMF compliance, inspection readiness, and industry challenges, featuring experts Paul Carter and Christina Mantzioros. image: https://info.montrium.com/hubfs/The%20SOTMF_feature%20image.png --- [![montrium logo blue](https://info.montrium.com/hs-fs/hubfs/montrium%20logo%20blue.png?width=200&height=100&name=montrium%20logo%20blue.png "montrium logo blue")](https://www.montrium.com) WE'RE BACK! # The State of TMF Podcast Each month, State of TMF covers the TMF issues surfacing in inspections and reaching leadership, from ICH E6(R3) and AI in oversight to the TMF Standard Model V1. Your hosts bring 35+ years of combined TMF and clinical operations experience. Paul Carter, Founder and CEO of Montrium, chairs the CDISC TMF Standards working group and sits on the TMF Reference Model Steering Committee. Christina Mantzioros, Director of Product and Clinical Intelligence at Montrium, has led global studies and built the clinical technology behind them. [**REGISTER NOW →**](https://info.montrium.com/state-of-tmf#register) ![SOTMF LP Image hero 750px shadow](https://info.montrium.com/hs-fs/hubfs/SOTMF%20LP%20Image%20hero%20750px%20shadow.png?width=750&height=750&name=SOTMF%20LP%20Image%20hero%20750px%20shadow.png) ## Listen to Previous Episodes Watch every past episode of State of TMF on YouTube. New episodes stream live each month.   ![SOTMF - Episode 26 Card LP no date](https://info.montrium.com/hs-fs/hubfs/SOTMF%20-%20Episode%2026%20Card%20LP%20no%20date.png?width=1200&height=627&name=SOTMF%20-%20Episode%2026%20Card%20LP%20no%20date.png) ### Episode #26 - The CRO TMF Handoff: The solution to hidden compliance gaps in CRO to sponsor TMF transfers Episode aired on March 24th, 2026 @ 11AM ET 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. [LISTEN](https://www.montrium.com/podcasts) ![SOTMF - Epiosde 27 Registration LP no date](https://info.montrium.com/hs-fs/hubfs/SOTMF%20-%20Epiosde%2027%20Registration%20LP%20no%20date.png?width=1200&height=627&name=SOTMF%20-%20Epiosde%2027%20Registration%20LP%20no%20date.png) ### Episode #27 - Documents without a plot: why your inspector can't follow your TMF Episode aired on April 29th, 2026 @ 11AM ET A complete TMF doesn't always mean a clear one. In this episode, we dig into one of the most common and underappreciated inspection risks: the TMF that technically has everything, but still can't tell you what actually happened. We break down the two root causes that derail TMF narratives: missing context (the "why" behind decisions and deviations) and missing connections (how documents relate and sequence into a coherent study story). We'll also look at how inspectors actually read a TMF, and what they're really looking for when they try to follow the thread. [LISTEN](https://open.spotify.com/episode/3zsEUQW8xAnASpRDVPDZMf?si=d3cde366a71143a7) ![State of TMF - EP #28](https://info.montrium.com/hs-fs/hubfs/Ep%2028_episode%20card_less%20blur.png?width=1200&height=627&name=Ep%2028_episode%20card_less%20blur.png) ### Episode #28 - TMF Standard Model V1: From Reference Model to Digital Standard Episode will air on October 29th, 2026 @ 11AM ET Two years in development, the TMF Standard Model V1 draft opens for community review on October 19. What changes for your team? Paul Carter and Christina Mantzioros explain what V1 is and how it differs from the TMF Reference Model. You'll hear why V1 is a digital, evidence-based standard built around ICH E6(R3). You'll also hear about the features that set V1 apart: record groups and record types, stable unique identifiers, and one model covering drugs, biologics, medical devices, IVDR, RWE, and the investigator site file. You'll learn how V1 gives you consistent, machine-readable TMF content you exchange across systems and organizations. You'll also learn the steps your team should take now to prepare. [REGISTER](https://info.montrium.com/state-of-tmf#register) ## Your Hosts The State of TMF podcast is hosted by experienced TMF'ers from Montrium. - ![Paul Carter](https://info.montrium.com/hubfs/Paul%20Carter-4.jpg) ### 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. - [LinkedIn](https://www.linkedin.com/in/paul-carter-360b531/) - ![Christina Mantzioros](https://info.montrium.com/hubfs/Christina%20Mantzioros.png) ### 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. - [LinkedIn](https://www.linkedin.com/in/christinamantzioros/) ## Register Now for State of TMF Podcast [REGISTER NOW](https://info.montrium.com/state-of-tmf#register) [JOIN THE COMMUNITY](https://hubs.ly/Q01DJHnL0) ## Built for TMF Professionals, by TMF Professionals One hour a month on the State of TMF podcast gives you guidance you apply to your TMF the next day. ### Spot compliance gaps before inspectors do Learn where TMF gaps surface during inspections and how to close them early. ### Stay current on what's changing in TMF Get guidance on the TMF Standard Model V1, AI in oversight, Quality by Design, record retention, and end-of-study handoffs. ### Join 1,000+ TMF professionals Ask your questions live and hear how peers handle the same challenges. ![2026\_SOTMF giveaway apparel gray](https://info.montrium.com/hubfs/2026_SOTMF%20giveaway%20apparel%20gray.png) ## Win a Custom State of TMF Hoodie 🔥 At every episode, one live attendee wins a two-sided "TMF'er for Life" hoodie. Join live and you're automatically entered!   ## Find us on your favourite podcast platform ![SPOTIFY-1](https://info.montrium.com/hubfs/SPOTIFY-1.svg) ![GOOGLE PLAY-1](https://info.montrium.com/hubfs/GOOGLE%20PLAY-1.svg) ![APPLE-1](https://info.montrium.com/hubfs/APPLE-1.svg) ![Youtube-1](https://info.montrium.com/hubfs/Youtube-1.svg) ## Register for the Upcoming Episodes The State of TMF podcast is a monthly event where you get practical, actionable knowledge and direct access to our hosts. Register and ask your questions live.   ## How to choose and eTMF system A practical guide for clinical teams [Download the guide](https://hubs.ly/Q04BgGVy0) ![eTMF Buyers Guide\_download 1200x800](https://info.montrium.com/hs-fs/hubfs/eTMF%20Buyers%20Guide_download%201200x800.png?width=1200&height=800&name=eTMF%20Buyers%20Guide_download%201200x800.png) ## Frequently Asked Questions Is each session recorded? Yes. All sessions are recorded and made available on YouTube and all major podcast platforms. 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](mailto: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.](https://www.linkedin.com/groups/8652372/) ## Listen to Montrium Podcasts on Your Favourite Platforms [![SPOTIFY](https://info.montrium.com/hubfs/6442a18ee63e6908a38b6477_spot.svg)](https://open.spotify.com/show/7ga1BYNp5JII1PocX4Dx6G?si=3f3ddd248e1c44f1&nd=1&dlsi=ecad010342ad456f) [![APPLE PODCASTS](https://info.montrium.com/hubfs/6442a18e9074c3c423526bf5_apple.svg)](https://podcasts.apple.com/us/podcast/the-state-of-tmf/id1678170625) [![YOUTUBE](https://info.montrium.com/hubfs/6442a18eabfe95d314166f48_you.svg)](https://www.youtube.com/playlist?list=PLWZ4jmEM4n2NsqC_aVfBPK_Z0v7nK1JW9) ## Footer [LinkedIn](https://www.linkedin.com/company/montrium/) [YouTube](https://www.youtube.com/user/Montrium) © 2026 Montrium Inc. All rights reserved.