Jason Weinstein, Business Lead and Manager for eTMF, REGENERON
Wendy Kelly, Manager, Global Development, SUNOVION
The Trial Master file has evolved over time in its function and capabilities. Beginning as a repository of clinical study artifacts, documents and data, it soon became a record of company processes, management and operations. Technology played a large part in the next leap in its evolution, allowing the TMF to facilitate the conduct of the study. eTMFs have evolved beyond study facilitation by becoming instruments for improvement in a myriad of arenas — internal collaboration, Quality, processes, and management.
Efficiency should not be underrated as an objective because having smooth operations is a prerequisite to achieving Inspection Readiness and Quality. You need to be sure that your processes and SOPs will ensure your success. Achieving a symbiosis between technology and processes means that you can make better decisions faster. This course will look at the tools and methods used to gather and analyze data, monitor trials, conducting oversight, and predicting and evaluating impact.
Upon completion of this course, participants will know or be able to:
- Optimize eTMF workflow through interoperable technologies with the way documents are created, collected, managed, and reported on
- Prepare TMF management processes and system changes resulting from the implementation of an eTMF
- Compare process challenges and solutions sponsor-owned vs. third-party-owned systems
- Establish necessary processes to support the use of a system at the point of launch
- Improve interoperability and speed with AI for extracting artifacts, emails, and data
- Critique dashboards, measurements, and metrics for their impact and their value toward analysis that leads to improvements
- Establish SOPs and KPIs that account for a CRO’s assessment systems
- Streamline processes to support work across functional units to work with vendors
- Plan and execute governance that facilitates change management and informed improvement
- Explain the essential requirements for a machine-to-machine exchange of TMF content
- Understand the implications of and available resources for the proposed TMF Exchange Mechanism for TMF automation
- Implement cross-functional Quality review and inspection preparation
*Courses include a continental breakfast at 8AM, two networking breaks, and lunch.