The State of TMF – Details, episodes & analysis

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The State of TMF

Montrium

Science

Education

Business

Frequency: 1 episode/32d. Total Eps: 27

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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Data updated on 05/08/2026

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https://www.youtube.com/watch?v=b_K49jS8bbs&amp
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https://www.instagram.com/montrium
14 shares

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Score global : 68%

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

Season 3 · Episode 6

Wednesday, April 23, 2025 • Duration 52:38

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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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/

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

Season 3 · Episode 5

Wednesday, February 19, 2025 • Duration 45:06

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/

Bridging Files - A look at the ISF Reference Model

Season 3 · Episode 4

Wednesday, January 22, 2025 • Duration 51:15

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/

Ask Paul - Our CEO Answers Your Most Pressing TMF Questions

Season 3 · Episode 3

Wednesday, December 11, 2024 • Duration 39:48

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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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/

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

Season 3 · Episode 2

Wednesday, November 20, 2024 • Duration 57:37

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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https://www.cdisc.org/sign-in

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

Season 3 · Episode 1

Wednesday, October 23, 2024 • Duration 49:45

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

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

Season 2 · Episode 9

Tuesday, June 25, 2024 • Duration 42:58

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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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/

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

Season 2 · Episode 8

Tuesday, May 14, 2024 • Duration 55:41

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:

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/

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

Season 2 · Episode 7

Tuesday, April 16, 2024 • Duration 52:56

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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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/

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

Season 2 · Episode 6

Tuesday, March 19, 2024 • Duration 33:20

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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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/

Daelight Solutions: https://daelightsolutions.com/

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The State of TMF – Details, episodes & analysis

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The State of TMF – Details, episodes & analysis

Podcast details

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