The State of TMF

Hosted by Montrium

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May 2026

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Welcome to the State of TMF podcast. 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'll understand everything it takes to create a world-class TMF program. As subscribers, you'll learn how to take your TMF process and strategy to the next level. Through interviews, AMAs, and invite-only events, we give you a sneak peek into the data-backed insights we're executing for TMF teams across the globe.

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27 recent

May 6, 202646 min

Documents without a plot: why your inspector can't follow your TMF

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.0:00 - The inspector confidence problem 0:53 - Welcome and introductions 2:35 - From paper TMF to digital overload 5:00 - What ICH E6(R3) really means 10:30 - Why more documents is riskier 13:30 - Relevant communications: what to file and what to cut 19:30 - How inspectors actually read a TMF 23:30 - Records living outside the TMF 34:30 - How AI helps with curation and essentiality 44:00 - The mindset shift: from filing to narrating 46:00 - What's coming next

April 1, 202646 min

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

This is no April Fools joke...The State of TMF podcast is back for a new season and we're jumping into a hot topic.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.CHAPTERS:0:00 Introduction1:00 Season 4 Premiere & Episode Overview2:00 Sponsor Oversight Challenges When CROs Manage the TMF7:00 When the CRO Hands the TMF Back: What to Expect10:00 Archiving the TMF: Where to Store It and What's in Scope13:00 TMF Plans, Data Transfer Agreements, and Authoritative Source17:00 Evaluating TMF Quality at Handover: Evidence of Oversight20:00 Risk-Based Oversight and ICH E6(R3) Requirements23:00 Q&A: Contract Timing, Cost Pressure, and CRO Access27:00 What Regulators Expect: Proactive vs. Reactive Oversight30:00 Q&A: Transferring Documents and Audit Trails35:00 How AI Can Improve TMF Oversight41:00 Q&A: Using AI Securely and Deterministically46:00 Closing & Season 4 Episode 2 Preview

April 23, 202552 min

Quality by Design: Bridging the TMF - Quality Gap in Your Study

In this episode, our experts will be diving into QbD and how this proactive approach is shaping clinical trial management. From ensuring compliance to improving overall trial efficiency, we’ll explore why embedding quality from the start is critical for clinical success.Joining us for this discussion is our President & CEO, Paul Fenton-Carter, and our Head of eTMF Services, Donatella Ballerini. Together, they’ll break down how QbD principles can enhance TMF quality, reduce risks, and future-proof trial documentation.-------------------------------------CHAPTERS:00:00 Hot Take w/ Paul Fenton-Carter00:40 Speaker Intros 01:39 It's a Jurassic World when it comes to quality (topic intro)05:32 The importance of quality in clinical trials08:58 Processes (SOPs) for quality14:45 How to define the list of essential records?19:22 Where QMS meets TMF & SOP33:20 Agile TMF vs the current TMF situation 33:04 Benefits of the integration, Manual integration and the future41:03 QbD is a mindset not just a methodology & questions49:24 Sign up for TMF Week 2025 & wrap up52:11 Outro----------------------------------------Sign up to TMF Week 2025: https://www.tmfweek.com/Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

February 19, 202545 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._____________________________________________CHAPTERS: 00:00 Hot Take w/ Joanne Malia00:30 Welcome and topic intro01:03 Guest intros (Joanne Malia and Karen Roy)03:53 Important changes to the final version of ICH E6 R306:39 Areas where risk-based approach is useful08:05 ICH M11 & digital protocol10:21 Names changes, terminology & guidance documents13:26 Question from the audience (Nomenclature)15:20 ICH and the TMF Reference Model17:25 Criteria /decisionguide20:14 Timeline for TMF Ref Model V422:45 Essential records table & Records that go across studies27:05 Questions from the audience 41:33 Wrap up44:41 Outro_____________________________________________Connect with Host and Guests: Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/ Joanne Malia: https://www.linkedin.com/in/jsmalia2008/Karen Roy: https://www.linkedin.com/in/karenjroy/ _____________________________________________TMF Reference Model V4 Refresh: https://www.cdisc.org/standards/trial-master-file-reference-modelSubscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

January 22, 202551 min

Bridging Files - A look at the ISF Reference Model

Host Paul Fenton-Carter of Montrium is joined by Jamie Toth of BeiGene and Matt Lowery of The Pathways Group, two key contributors deeply involved in shaping this groundbreaking project. Together, they explore the progress made so far, the challenges faced, and what the future holds for the ISF Reference Model. From aligning global teams to addressing practical implementation hurdles, this episode offers valuable insights for anyone invested in improving clinical trial documentation practices.CHAPTERS:00:00 Hot Take w/ Matt Lowery00:35 Guest intros (Jamie Toth and Matt Lowery)01:55 Topic Intro & History of ISF04:20 ISF Initiative Overview and Timeline10:32 ISF Facts12:28 ISF Structure21:09 A snapshot of final draft of the ISF Reference Model 22:39 Quiz Time23:38 Final draft snapshot continued25:25 Matt's take on packages and sub-packages26:24 How does the TMF Reference Model align with the ISF29:30 The three additional ISF artifacts34:09 ISF Initiative ongoing and future activities & questions48:51Wrap up and final thoughts 50:49 Outro------------------------------------------------------------Connect with Host and Guests: Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/ Jamie Toth: https://www.linkedin.com/in/jamie-marie-t-759772/ Matt Lowery: https://www.linkedin.com/in/mattlowery/ ------------------------------------------------------------Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

December 11, 202439 min

Ask Paul - Our CEO Answers Your Most Pressing TMF Questions

Get ready for an engaging and interactive episode of The State of TMF! Montrium’s CEO, Paul Fenton-Carter, takes center stage for a no-holds-barred AMA (Ask Me Anything) session.Paul will be answering questions submitted by the audience, diving into key topics shaping the TMF industry today, from current challenges in clinical documentation to the future of TMF management in a rapidly evolving landscape. Whether you’re curious about his vision for the industry, best practices for TMF management, or insights into upcoming trends, this is your chance to hear directly from one of the leading voices in the field.CHAPTERS:00:00 Topic Teaser w/ Paul Fenton-Carter00:28 Speaker and topic intros01:36 Exploring how the role of the TMF manager is evolving06:05 Examining the industry's progress in adopting risk-based TMF management12:40 Insights on the rapid incorporation of AI and its impact on TMF management18:02 Discussing the challenges of accurately measuring completeness24:25 Understanding the importance of ICH M11 and its impact on TMF31:00 Key considerations around ICH E6(R3) and its implications for TMF37:39 Addressing common misconceptions about TMF38:40 Wrap up39:20 Outro_______________________________________________Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

November 20, 202457 min

Setting New Standards: What's in V4 of the TMF Reference Model?

A lot has changed since Version 3 of the TMF Reference Model was released in 2015. The growing adoption of digital technologies, combined with increasing amounts of data collection, have made for a vastly different landscape—one that requires different approaches to TMF management. Thus, enter: Version 4 of the TMF Reference Model.In this expert-led breakdown of V4, Montrium's President & CEO (and new co-chair of the TMF Reference Model) Paul Fenton-Carter is joined by the model's founder and former chair, Karen Roy. Together, they'll explore the new features and changes you'll be seeing in V4, as well as the impact these updates will have on clinical documentation management practices in the digital age.CHAPTERS:00:00 Topic Teaser w/ Karen Roy00:25 Topic intro00:43 Speaker intros w/ Paul Fenton-Carter & Karen Roy02:27 History of the TMF Reference Model07:25 Regulatory Evolution and other factors10:00 What is a Digital TMF12:23 Benefits of becoming a Digital Standard17:01 The Data Driven Approach & Digital Protocols23:28 Heads of TMF and what they need to know about USDM26:54 The future of TMF Reference Model V4 & Goals35:09 The importance of standardizing Sub-Artifacts 43:51 V4 (TMF RM) Org Chart51:15 How to get involved?56:15 Wrap up57:11 Outro________________________________________________________________CDISC Sign-In: https://www.cdisc.org/sign-in Paul Fenton-Carter email: pfenton@montrium.com Karen Roy's email: kroy@cdisc.org Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

October 23, 202449 min

Unlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMF

From paper to pixels, the TMF has come a long way in its digital transformation—and so have the ways in which we manage it.In this episode, Paul Fenton of Montrium and Nick Hargaden of Moderna will explore the future of the TMF as it transitions into a fully digital landscape. We'll discuss the current gaps that prevent TMF from being truly digital and examine key industry initiatives, including ICH M11 and Digital Data Flow from Transcelerate, to understand their impact on eTMF systems. We'll also highlight the benefits of a data-driven approach in enhancing quality, timeliness, and compliance, while revealing how it can unlock the vast goldmine of information stored within the eTMF to improve oversight and streamline clinical process management.CHAPTERS00:00 Topic Teaser00:50 Speaker intros03:36 Topic intro04:30 The Heart of Digital TMF and the new standard ICH M1117:20 How will the new standards affect Sponsors and CROs?19:41 Functions impacted outside of TMF with the new standard25:00 Impact on the vendor ecosystem29:24 The regulatory impact 34:50 How can Sponsor adapt to the new standard?37:24 Will Regulatory bodies be lenient with the changes?40:05 Regulatory processes42:30 Hurdles Vendors and Sponsors might face with the implementation of M1145:45 How to prepare for the changes48:25 Wrap up49:15 Outro_____________________________________________Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

June 25, 202442 min

More than an Archive - Moving to an Active TMF Management Model

Managing your TMF program effectively with outdated or inefficient processes can feel overwhelming, especially with limited resources and an evolving regulatory environment. Today, teams are transitioning away from passive TMF models that prioritize an archivist mindset towards a more modern and agile approach to TMF focused on managing and compiling the TMF in an active manner.In this session, Donatella Ballerini and Oliver Pearce of Montrium will guide you through the essential components of active TMF management. They will introduce Montrium's TMF Maturity Model, providing a structured approach to evaluate and advance your TMF processes. You'll learn how to leverage technology for real-time oversight and ensure your TMF team maintains an agile TMF mindset.---------------------------------------------------------Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

May 14, 202455 min

Battle of the Binders: What's the Difference Between the TMF & the ISF?

Distinguishing between the ISF and the TMF is an all-too-frequent source of confusion in clinical documentation. Are they the same? Are they different? The answer to both of those questions is yes.Join special guests Aryn Knight and Matt Lowery as they get into the nitty gritty of the great ISF-TMF debate. We'll be covering which contents are specific to the ISF vs which are specific to the TMF, who is responsible for each, their different regulatory requirements, and inspection readiness for both.---------------------------------------------------------Aryn Knight on LinkedIn: Matt Lowery on LinkedIn: Register for for episode #9 @TMF Week 2024Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/

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