Webinar
How to turn poor TMF quality into TMF operational excellence
In this webinar, Chris Englerth, our Director of Global Consulting Services, will moderate a session alongside Rob Jones, our Product Manager for the TMF Practice Area. Discover expert guidance and pragmatic tips on how leading organizations are achieving and maintaining a healthy Trial Master File – defying an industry trend of poor TMF quality that is causing avoidable risk and delays in trial conduct and marketing applications. We will examine best practices from TMF teams across small, mid-sized, and large biopharmaceutical companies. These teams have developed effective tools and processes to manage TMF completeness, quality, and timeliness, regardless of resource constraints.
Key learnings
- Root cause analysis of what leads to poor TMF quality
- Case studies of how biopharma companies have achieved sustained TMF excellence
- Pragmatic steps common to all successful TMF organizations, including:
- Implementing, monitoring, and taking action on robust TMF metrics
- Applying risk-based TMF quality review and quality checks
- Building quality, completeness, and timeliness metrics into CRO discussions and agreements from the start
- Creating a culture of collaboration and transparency around the TMF that encompasses other internal departments as well as services providers
- Aligning people, process, and technology to the same goals
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