How to turn poor TMF quality into TMF operational excellence
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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