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Biopharmaceutical Company with Virtual Operations

CRAs in different locations presented operational challenges.

Challenges

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Challenges

  • 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
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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
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