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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

challenge 3

Challenges

  • 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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Success 2

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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