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Global Biotech Company With 400 Employees

To prepare for mock inspection, the company needed to scan over one hundred thousand documents into the eTMF.

Trial Interactive TMF services mitigated the risks of paper process by stewarding the move to an eTMF.

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Challenges

  • Managing multiple simultaneous global studies with paper documents spread across many locations
  • Moving from paper TMF processes to an electronic TMF and establishing best practices eTMF management
  • Preparing for a mock inspection
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Outcome & ROI

  • TransPerfect’s experts were able to scan, code, QC, and merge all paper documents into the eTMF under extremely tight deadlines.
  • The global presence of those services mitigated risk, sped up timelines, and reduced costs by limiting the shipment of essential documents (many of which were able to be physically picked up and transported by TransPerfect employees).
  • The Biotech organization was able to pass their mock inspection to ensure inspection readiness.
  • TransPerfect helped to establish the protocols and SOPs for managing the eTMF moving forward. 
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