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- The transition from Sharepoint to an e-clinical platform with best-of-breed eTMF technology
- Scanning and uploading all documents into the eTMF
- Managing an eTMF within a fully virtual company with mobile CRAs
- Establishing eTMF SOPs and best practices for future studies
- Preparing for and pass mock inspection
Outcome & ROI
- Audit features, dashboards, and KPIs allowed the Biopharma to maintain oversight of TMF health, maintaining inspection-readiness.
- The company was also able to pass their mock inspection
- Trial Interactive's mobile app (myTI) allowed the CRAs and trial managers to maintain real-time inspection readiness from various locations, turning a challenger into a strength
- Transperfect's expert TMF Services were able to upload and merge all documents required into the eTMF, as well as adapt and configure custom rooms when necessary
- The Biopharmaceutical company leveraged myTI with CRA reconciliation support to manage the eTMF oversight