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- 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
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.