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EU-Based Pharmaceutical Manufacturer Running a Phase III Study with 150+ Sites

This company needed an organized and centralized eTMF in preparation for regulatory agency submission.

TransPerfect's Trial Interactive eTMF platform and expert TMF services enable global sponsors to go paperless and create transparency for proactive and effective oversight.

Challenges

Challenges

  • There were hundreds of boxes of paper files that all needed to go into the eTMF.
  • There were missing essential documents that were poorly filed.
  • The pharmaceutical manufacturer needed to organize their TMF and ensure they were inspection ready without delaying the study any further.
  • The company was looking to implement a platform for a larger move to fully electronic TMF processes.
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Outcomes

Outcome/ROI

  • The TransPerfect TMF services team was able to scan, code, QC, and upload all documents into the eTMF while reconciling missing essential documents.
  • The informative dashboards, KPIs, and reports. provided by our eTMF interface allowed for a clearer picture of the overall health of the TMF moving forward.
  • Transperfect’s Trial Interactive eTMF could be configured to the specific workflows required of the company to increase oversight and control.
  • Overall costs of managing the TMF were reduced by ~25%.
  • The company passed regulatory inspection and the drug was approved.
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