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- 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.
- 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.