The State of TMF

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

Wed, 01 Apr 2026 09:17:00 -0400

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

Wed, 23 Apr 2025 13:00:00 -0400

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.

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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

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

Wed, 19 Feb 2025 13:15:00 -0400

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.

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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

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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/

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TMF Reference Model V4 Refresh: https://www.cdisc.org/standards/trial-master-file-reference-model

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Bridging Files - A look at the ISF Reference Model

Wed, 22 Jan 2025 16:53:00 -0400

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

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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/

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Ask Paul - Our CEO Answers Your Most Pressing TMF Questions

Wed, 11 Dec 2024 15:10:00 -0400

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-Carter

00:28 Speaker and topic intros

01:36 Exploring how the role of the TMF manager is evolving

06:05 Examining the industry's progress in adopting risk-based TMF management

12:40 Insights on the rapid incorporation of AI and its impact on TMF management

18:02 Discussing the challenges of accurately measuring completeness

24:25 Understanding the importance of ICH M11 and its impact on TMF

31:00 Key considerations around ICH E6(R3) and its implications for TMF

37:39 Addressing common misconceptions about TMF

38:40 Wrap up

39:20 Outro

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

Wed, 20 Nov 2024 13:15:00 -0400

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 Roy

00:25 Topic intro

00:43 Speaker intros w/ Paul Fenton-Carter & Karen Roy

02:27 History of the TMF Reference Model

07:25 Regulatory Evolution and other factors

10:00 What is a Digital TMF

12:23 Benefits of becoming a Digital Standard

17:01 The Data Driven Approach & Digital Protocols

23:28 Heads of TMF and what they need to know about USDM

26:54 The future of TMF Reference Model V4 & Goals

35:09 The importance of standardizing Sub-Artifacts

43:51 V4 (TMF RM) Org Chart

51:15 How to get involved?

56:15 Wrap up

57:11 Outro

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CDISC Sign-In: https://www.cdisc.org/sign-in

Paul Fenton-Carter email: pfenton@montrium.com

Karen Roy's email: kroy@cdisc.org

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

Wed, 23 Oct 2024 14:15:00 -0400

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.

CHAPTERS

00:00 Topic Teaser

00:50 Speaker intros

03:36 Topic intro

04:30 The Heart of Digital TMF and the new standard ICH M11

17:20 How will the new standards affect Sponsors and CROs?

19:41 Functions impacted outside of TMF with the new standard

25:00 Impact on the vendor ecosystem

29:24 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 processes

42:30 Hurdles Vendors and Sponsors might face with the implementation of M11

45:45 How to prepare for the changes

48:25 Wrap up

49:15 Outro

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

Tue, 25 Jun 2024 15:21:00 -0400

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.

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

Tue, 14 May 2024 17:00:00 -0400

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.

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Aryn Knight on LinkedIn:

Matt Lowery on LinkedIn:

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Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews

Tue, 16 Apr 2024 11:00:00 -0400

Audit trail reviews may be a hot topic in the world of TMF right now, but that doesn't mean people know how to do them the right way.

In this episode of The State of TMF, our experts will explain everything you need to know about audit trail reviews. We'll be going over the basics of audit trail reviews, the "why" and "how" of routine ATRs, which high-risk data points you should be reviewing, and more!

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Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study

Tue, 19 Mar 2024 14:00:00 -0400

It's important to have standards—especially when it comes to the TMF index. Aligning your TMF index to the CDISC TMF Reference Model makes it easy for organizations to speak the same language, helps you breeze through M&As, and streamlines system migrations.

In this episode of the State of TMF, our host Oliver Pearce will be joined by guest Anne Ackley-Fifer from Daelight Solutions. They'll discuss how you can build a flexible and adaptive TMF index for any study, without straying from the standard

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Daelight Solutions: https://daelightsolutions.com/

Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged

Tue, 20 Feb 2024 11:15:00 -0400

If the TMF is the cornerstone of a clinical trial, then why do so many TMFers find themselves having to convince others of its importance?

The answer: culture. In this episode, we crack the TMF culture code and explain how you can get stakeholder buy-in, keep non-TMFers engaged, and ensure that everyone is doing their part. Our experts will discuss tips for training, ways to gamify TMF management, the process of creating TMF champions, and more!

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Crafting a TMF Training Program for your Team

Tue, 16 Jan 2024 12:00:00 -0400

We kicked off 2024 with our most popular State of TMF episode yet! Loads of you turned up to last week to learn more about TMF training—and how to do it right.

Not only did our hosts share their foolproof 5-step formula for crafting an effective TMF training program for your team, but they also got real about some of the training struggles they've faced throughout their careers.

If you or your team ever struggle to understand roles, responsibilities, TMF maturity levels, and any of the other complexities that come with this line of work—then this episode is for you!

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Risk-Based TMF Management 101

Tue, 19 Dec 2023 15:00:00 -0400

Risk-based TMF management is set to be all the rage in 2024, and we want to help you hit the ground running. On the latest episode of The State of TMF, our experts shared their innovative and unique approach to risk-based TMF.

They were also be joined by InSeption Group's EVP of QA & Compliance, Dawn Niccum, to discuss the past, present and what all TMF'ers need to know about the imminent future of risk-based TMF.

Plus, get a FREE copy of our brand-new white paper detailing our approach to risk-based TMF management.

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Trackers & Logs in the TMF: Where to file them?

Tue, 28 Nov 2023 15:15:00 -0400

Trackers and logs are a notorious source of confusion in the TMF. But fear not, because our experts joined forces to discuss exactly where you should be filing trackers and logs in your TMF.

They also shared a real (scary) story about what happens when an inspector asks to see a log that wasn't maintained 😱 and how you can avoid this happening to you.

How are you enjoying The State of TMF series? We want to know what you love, what you don't love, and your suggestions for making it the most valuable podcast possible. You'll also get the chance to leave your own burning question(s) on the hot topic of risk-based TMF so we'll be sure to cover them in the next episode.

You can fill out the super quick, 2-minute touchpoint by clicking this link

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TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023

Wed, 01 Nov 2023 10:00:00 -0400

Our experts sat down to discuss the unexpected findings from our first-ever industry report and graced us with some non-stop fire insights about the TMF world of today, and tomorrow. It was the perfect way to kick off the second season of The State of TMF.

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Inspection readiness toolset - What tech do we need for the future?

Tue, 05 Sep 2023 11:30:00 -0400

On the final episode of Season 1 of The State of TMF, our panel of experts did a deep dive into the tools you need to be inspection-ready—today AND tomorrow. Our host, Oliver Pearce, was joined by Paul Fenton and Donatella Ballerini from Montrium, and Jamie Toth from BeiGene.

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Is eTMF tech working for small companies?

Wed, 16 Aug 2023 11:00:00 -0400

In this "food for thought" episode, our panel of experts explored the challenges presented by the eTMF technology currently available in the life sciences industry. Paul, Christina, and Oliver offered practical and actionable recommendations that small companies can take when implementing an eTMF system.

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Once Upon a TMF: Boosting Inspection Readiness with Storyboarding

Wed, 02 Aug 2023 11:00:00 -0400

In this insightful session, Oliver Pearce and Donatella Ballerini reveal how storyboarding can become your secret weapon in boosting confidence when it comes to the inspection readiness of your TMF.

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Lights, Camera, Inspection: Performing Oscar-Worthy Mock Inspections

Wed, 19 Jul 2023 11:00:00 -0400

In this episode, experts Oliver Pearce and Christina Mantzioros turn the spotlight on the undeniable benefits of mock inspections, with actionable insights to put them into play and bolster your inspection readiness success from here on out.

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The New Inspection Frontier - Navigating Remote & Hybrid GCP Inspections

Wed, 05 Jul 2023 11:00:00 -0400

In this riveting episode, our panel of experts took a deep dive into the evolving world of remote and hybrid inspections, and offered their best tips for how to be better prepared for this new reality. Featuring Paul Fenton of Montrium, Joanne Malia of Regeneron, and David Ives of Daelight Solutions

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Set Yourself up for Inspection Success: Leveraging TMF Health Checks & Oversight

Thu, 22 Jun 2023 11:00:00 -0400

The State of TMF is BACK, and in this episode, our experts will be discussing how to set yourself up for inspection success with TMF health checks and oversight.

You'll come away with practical tips and actionable insights to help you maximize your inspection readiness.

Sound interesting? Then listen now!

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Mergers, Acquisitions & Shelved Compounds: Dealing with TMFs with Steph Viscomi & Dawn Niccum

Wed, 03 May 2023 11:00:00 -0400

In this episode, we'll be tackling the complex situations that can quickly turn into a TMF manager's nightmare: mergers, acquisitions, and shelved compounds.

Your favourite host, Oliver Pearce, will be joined by expert guests Steph Viscomi and Dawn Niccum to discuss how to navigate these processes without losing too much sleep.

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Numbers don't lie - Building a TMF Metrics Program from the Ground Up

Wed, 19 Apr 2023 11:00:00 -0400

Metrics, metrics, metrics. Despite metrics being one of the most popular topics in the world of TMF, there's still a fair bit of confusion about what they entail and how to leverage them correctly.

We'll be tackling this confusion head-on and addressing some of the most prominent knowledge gaps when it comes to metrics in the third episode of The State of TMF.

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You've got mail - Building an intuitive process for TMF correspondence.

Wed, 05 Apr 2023 11:00:00 -0400

TMF correspondence can be tricky. Have you ever found yourself asking what to keep, what not to keep, and where to keep it? Well, you're not alone. These are all perfectly normal questions that come up often when managing a TMF.

In this episode, you'll learn how to properly manage TMF correspondence and how to put in place a process that your team can rely on. Join us for episode #2 of the State of TMF podcast.

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Confessions of an Ex-TMF Manager - Breaking Bad Habits with Note to Files.

Mon, 20 Mar 2023 14:00:00 -0400

To file or note to file? That is the question. And it's one that continues to plague TMF professionals of all levels of experience. In this episode, we'll be discussing the dos and don'ts of writing note to files (NTFs) and how to develop a process that builds confidence in an inspection instead of undermining it. Join us for our very first episode of the State of TMF podcast.

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