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US-Based Biopharmaceutical Company With Over 350 Employees

This company was looking to reconcile a phase III study with over 450 global sites.

Trial Interactive TMF services can scan, code, QC, and merge thousands of paper documents into the eTMF and keep studies on track


  • Reconciling a phase III study with seven CROs and vendors with their own TMF standards
  • Increasing TMF quality and establish a culture of inspection readiness
  • Scanning, coding, QCing, and merging over one hundred and fifty thousand documents (three hundred thousand pages) into the eTMF
  • Establishing processes and procedures for future use of an eTMF
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Outcomes & ROI

  • TransPerfect’s experts were able to scan, code, QC, and merge all paper documents into the eTMF without delaying the study.
  • The company was able to establish a centralized eTMF process and increase oversight with the numerous vendors involved.
  • They were able to ensure inspection readiness and submit the study to regulatory agencies with confidence.
  • TransPerfect helped to establish processes for using an eTMF moving forward with continued partnership and support.
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