The State of TMF

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 ev

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 bo

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 t

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 evol

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 groundb

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)

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

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

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Managing your TMF program effectively with outdated or inefficient processes can feel overwhelming, especially with limited resources and an evolving regulatory environme

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

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

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

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

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 sp

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

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 e

Crafting a TMF Training Program for your Team

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

Risk-Based TMF Management 101

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

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

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 a

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

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, a

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

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, Ol

Is eTMF tech working for small companies?

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,

Once Upon a TMF: Boosting Inspection Readiness with Storyboarding

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 inspe