On the Frontlines of Clinical Operations: Recent Episodes
Agatha Life Inc.
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 evolving
- Why CROs and Sponsors need to work together to manage the TMF successfully
- How the right eTMF enforces process coordination and collaboration
- The key features of a modern eTMF application
- How 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 approach
- Tips 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 process
- Moving to remote monitoring and decentralized trials
- The different approaches for Sites to participate in the TMF
- The challenges and how to overcome them
- How 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 readiness
- Features and functionality to look for
- Implementation 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 internally
- Budget planning
- How to get executive support
- What 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 management
- What 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.
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