))
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 ...
…
continue reading
1
More than an Archive - Moving to an Active TMF Management Model
42:58
42:58
Play later
Play later
Lists
Like
Liked
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Managing your TMF program effectively with outdated or inefficient processes can feel overwhelming, especially with limited resources and an evolving regulatory environment.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 compili…
…
continue reading
1
Battle of the Binders: What's the Difference Between the TMF & the ISF?
55:41
55:41
Play later
Play later
Lists
Like
Liked
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 spec…
…
continue reading
1
Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews
52:56
52:56
Play later
Play later
Lists
Like
Liked
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 h…
…
continue reading
1
Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study
33:20
33:20
Play later
Play later
Lists
Like
Liked
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 Ac…
…
continue reading
1
Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged
56:30
56:30
Play later
Play later
Lists
Like
Liked
56:30
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…
…
continue reading
1
Crafting a TMF Training Program for your Team
53:12
53:12
Play later
Play later
Lists
Like
Liked
53:12
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 …
…
continue reading
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 al…
…
continue reading
1
Trackers & Logs in the TMF: Where to file them?
54:38
54:38
Play later
Play later
Lists
Like
Liked
54:38
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 y…
…
continue reading
1
TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023
51:59
51:59
Play later
Play later
Lists
Like
Liked
51:59
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. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> …
…
continue reading
1
Inspection readiness toolset - What tech do we need for the future?
35:56
35:56
Play later
Play later
Lists
Like
Liked
35:56
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. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Jo…
…
continue reading
1
Is eTMF tech working for small companies?
45:59
45:59
Play later
Play later
Lists
Like
Liked
45:59
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. Subscribe to The State of TMF Live Events ->…
…
continue reading
1
Once Upon a TMF: Boosting Inspection Readiness with Storyboarding
54:25
54:25
Play later
Play later
Lists
Like
Liked
54:25
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. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0…
…
continue reading
1
Lights, Camera, Inspection: Performing Oscar-Worthy Mock Inspections
52:11
52:11
Play later
Play later
Lists
Like
Liked
52:11
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. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to ke…
…
continue reading
1
The New Inspection Frontier - Navigating Remote & Hybrid GCP Inspections
50:32
50:32
Play later
Play later
Lists
Like
Liked
50:32
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 Subscribe to The State of TMF Live Events -> http…
…
continue reading
1
Set Yourself up for Inspection Success: Leveraging TMF Health Checks & Oversight
56:55
56:55
Play later
Play later
Lists
Like
Liked
56:55
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! Subscribe to The State of TMF Live Events -…
…
continue reading
1
Mergers, Acquisitions & Shelved Compounds: Dealing with TMFs with Steph Viscomi & Dawn Niccum
1:01:25
1:01:25
Play later
Play later
Lists
Like
Liked
1:01:25
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. Subscribe to The Sta…
…
continue reading
1
Numbers don't lie - Building a TMF Metrics Program from the Ground Up
48:45
48:45
Play later
Play later
Lists
Like
Liked
48:45
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 S…
…
continue reading
1
You've got mail - Building an intuitive process for TMF correspondence.
1:03:46
1:03:46
Play later
Play later
Lists
Like
Liked
1:03:46
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 …
…
continue reading
1
Confessions of an Ex-TMF Manager - Breaking Bad Habits with Note to Files.
1:02:03
1:02:03
Play later
Play later
Lists
Like
Liked
1:02:03
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…
…
continue reading
