On the Frontlines of Clinical Operations

The Trial Master File (TMF) is the repository for all essential documents supporting a clinical trial. But its role is going beyond a simple storage container for files, as CROs and Sponsors work together to manage not only the collection of TMF documents but also the review and inspection processes, both internally and externally. In this episode, Agatha’s Head of North American Operations, Ken Lownie, and Kari Brown, Director of Clinical Operations, DZS Clinical Services, discuss: The role of the TMF and how it is evolvingWhy CROs and Sponsors need to work together to manage the TMF successfullyHow the right eTMF enforces process coordination and collaborationThe key features of a modern eTMF applicationHow to build a shared responsibility model for the TMF

Welcome to the final episode in our series: Bringing the TMF In-House, a guide to help sponsors understand what's involved with bringing the management of the trial master file in-house and how they can do it successfully. In our final episode, Janine and Ken talk about managing the TMF on-going and how to prepare for inspection readiness. Topics include: Do you need eTMF software to get inspection-ready?What is a reactive approach to inspection vs a readiness approachTips for ongoing management of the TMF, including what to watch for We hope you enjoyed this series and we would love to hear what you thought about the series. Drop us an email and share your thoughts!

We're continuing our series: Bringing the TMF In-House with episode 6 - Integrating Clinical Sites into the TMF Process. In this episode Ken and Janine discuss: The role sites play in the TMF management processMoving to remote monitoring and decentralized trialsThe different approaches for Sites to participate in the TMFThe challenges and how to overcome themHow to get started with a remote site model.

Episode 5 of our Bringing the TMF In-House series is all about technology. Ken and Janine talk about: eTMF software available today and how it has evolved. How an eTMF solution supports inspection readinessFeatures and functionality to look forImplementation and Cost considerations.

This is the fourth episode in our series: Bringing the TMF In-House. In this episode, Ken and Janine walk you through the key stakeholders you need to involve in a TMF project and how, as well as the things you need in place to ensure project success, such as sponsorship, communications, metrics, cadence, and technology.

In our third episode in our Bringing the TMF In-House series, Ken and Janine talk about the resources you will need and key budget considerations. They cover these topics for both the initial project and for long-term management of the TMF.

This is episode two of the series "Bringing the TMF In-house: A Sponsors Guide to Taking Back Your TMF." All good plans start with a foundation. In this episode: Laying the foundation, Ken and Janine Penman talk about all the things you need to think about and plan for when you decide it's time to bring the TMF in-house. Following episodes will dive deeper into these topics and more. The first steps you need to take to manage your TMF internallyBudget planningHow to get executive supportWhat happens when you don't have the right resources in-house.

Join Agatha Head of North American Operations, Ken Lownie, and Janine Penman, JPScientific, as they take you through the strategy of bringing your TMF in-house.   In part one of the series, Ken and Janine discuss the following: Who typically "owns" the TMF?Is there a pattern between larger and smaller sponsors as to when the TMF is usually outsourced?What is the "best practice" for smaller, clinical-stage sponsors regarding TMF managementWhat is driving the need to bring the TMF in-house and how do you know WHEN it makes sense for a specific organization to think about taking the TMF in-house?  The challenges involved when moving from your CRO managing the TMF to bringing it in-house. Sign up for Agatha's newsletter to get updated when each new episode in the series goes live and to get additional insights on each episode.