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

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

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 Introduction 1:00 Season 4 Premiere & Episode Overview 2:00 Sponsor Oversight Challenges When CROs Manage the TMF 7:00 When the CRO Hands the TMF Back: What to Expect 10:00 Archiving the TMF: Where to Store It and What's in Scope 13:00 TMF Plans, Data Transfer Agreements, and Authoritative Source 17:00 Evaluating TMF Quality at Handover: Evidence of Oversight 20:00 Risk-Based Oversight and ICH E6(R3) Requirements 23:00 Q&A: Contract Timing, Cost Pressure, and CRO Access 27:00 What Regulators Expect: Proactive vs. Reactive Oversight 30:00 Q&A: Transferring Documents and Audit Trails 35:00 How AI Can Improve TMF Oversight 41:00 Q&A: Using AI Securely and Deterministically 46:00 Closing & Season 4 Episode 2 Preview

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-Carter 00:40 Speaker Intros 01:39 It's a Jurassic World when it comes to quality (topic intro) 05:32 The importance of quality in clinical trials 08:58 Processes (SOPs) for quality 14:45 How to define the list of essential records? 19:22 Where QMS meets TMF & SOP 33:20 Agile TMF vs the current TMF situation 33:04 Benefits of the integration, Manual integration and the future 41:03 QbD is a mindset not just a methodology & questions 49:24 Sign up for TMF Week 2025 & wrap up 52:11 Outro ---------------------------------------- Sign up to TMF Week 2025: https://www.tmfweek.com/ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

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 Malia 00:30 Welcome and topic intro 01:03 Guest intros (Joanne Malia and Karen Roy) 03:53 Important changes to the final version of ICH E6 R3 06:39 Areas where risk-based approach is useful 08:05 ICH M11 & digital protocol 10:21 Names changes, terminology & guidance documents 13:26 Question from the audience (Nomenclature) 15:20 ICH and the TMF Reference Model 17:25 Criteria /decisionguide 20:14 Timeline for TMF Ref Model V4 22:45 Essential records table & Records that go across studies 27:05 Questions from the audience 41:33 Wrap up 44:41 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-model Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

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 Lowery 00:35 Guest intros (Jamie Toth and Matt Lowery) 01:55 Topic Intro & History of ISF 04:20 ISF Initiative Overview and Timeline 10:32 ISF Facts 12:28 ISF Structure 21:09 A snapshot of final draft of the ISF Reference Model 22:39 Quiz Time 23:38 Final draft snapshot continued 25:25 Matt's take on packages and sub-packages 26:24 How does the TMF Reference Model align with the ISF 29:30 The three additional ISF artifacts 34:09 ISF Initiative ongoing and future activities & questions 48:51Wrap 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/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/