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! ----------------------------------------------- Subscribe to The State of TMF Live Events:...

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...

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...

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...

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...

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...

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 -> https://hubs.ly/Q027nggP0 Read the State of TMF Industry Report 2023 -> https://hubs.ly/Q027nlrf0

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 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

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 -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

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

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 keep learning -> https://hubs.ly/Q01DJHnL0

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 -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

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 -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

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 State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

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. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning ->...

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.   Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join...

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. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community ->...