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TMF Document Services

Scale your trial master file document processing. Stay Inspection Ready.

With millions of documents processed to date, 22 TMFs rescued mid-study, and an ongoing tally of FDA, MHRA, and EMA inspections successfully completed, your TMF is in the most vetted and experienced hands, led by long-time industry professionals and TMF Reference Model committee members.

 

document mapping

Document Mapping and Remapping

Compliance and searchability are the primary goals of TMF indexing. As industry leaders in TMF solutions and innovation, we have the experience required to handle complexity, be it disparate document sources or formats. Following the TMF Reference Model and your SOPs, documents are converted with the necessary metadata and filing structures.

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TMF Scanning Coding

Scanning and Transfer

Speed and accuracy with a complete audit trail. A global team of document specialists follows our vetted process for quality and compliance. Each TMF document specialist is capable of processing up to 100 documents daily, with millions of documents processed to date. Make sure trusted professionals are managing your TMF scanning.

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tmf coding tmf scanning tmf qc tmf reference model

Coding and QC

Guided by DIA TMF Reference Model committee members and career TMF document specialists, your clinical study TMF documents are indexed according to reference model and/or SOP requirements for quality and completeness. All documentation processed receives a standard 7-point check. Documents can be further QCed via our Quality Team’s QC workflow or according to your specific SOPs. Get your TMF coding done by the experts.

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tmf staffing

Archiving

Your TMF archiving needs can be met in any format required. Our experts ensure your records are highly secure, compliant with regulations, and always accessible. The administrative burden of archiving is trusted in the hands of TransPerfect so that study teams can focus on patients and timely completion of the clinical trial.

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TMF Document Services Features

  • Paper Scanning and Document Transfer

  • Document Processing in Any System

  • Quality Review and Completeness Analysis

  • TMF Audits

  • TMF Migrations

  • Secure Archiving

Document Processing in Any System

No matter your eTMF system of record, our document specialists will process your TMF documentation to ensure quality, completeness, and health.

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