On-Demand Expertise

TMF Management

Supplement your internal team with career TMF professionals who can help guide the end-to-end management of your TMF. Many teams new to eTMF leverage our experts to ensure success.

TMF Rescue

Nearly two dozen TMFs have been rescued by our TMF Inspection Readiness Solutions team, saving these studies from unnecessary inspection findings and timeline delays. If your TMF is at risk, our team is at the ready to restore completeness and health to your TMF so you are inspection ready.

Best Practices and Procedural Documents

Get an expert TMF specialist review of current processes and procedural documentation to establish current best practices and author or amend SOPs and other key documentation to ensure an optimal approach to compliance.

TransPerfect and our industry-leading Trial Interactive e-clinical platform are pioneers of eTMF. With over 10+ years of successful eTMF implementation experience, you can be sure your implementation is guided by a knowledgeable and vetted partner. 

• Implementation  
• Document Processing 
• Oversight

Inspection Readiness

Completeness analysis often is left until late in the study. Our experts will review your TMF to see what still may remain to be completed. Remove any doubts about your approach to inspection-readiness with the input of career professionals and trial master file reference model committee members.  

We enable successful regulatory agency inspections. Many study teams are unsure of next steps or how to properly prepare for overall TMF compliance and completeness. Additionally, they may not have resources available internally to perform the steps necessary to plan for success and compliance. We have the expertise, resources, and trusted approach necessary to stay inspection ready.

• Gap Analysis 
• Audit and Inspection Prep 
• Periodic Audits 
• Completeness Checks 
• GCP Inspection 

Governance

Establishing ongoing governance practices is essential to an inspection-ready TMF. Sponsors and CROs alike refer to our experts to roll out TMF governance.

Multilingual Translation Support

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.

Leverage senior experts to consult on your approach to TMF management or provide workshops to train personnel. TransPerfect Life Sciences offers a full suite of services designed to help study teams leverage career TMF professionals and establish best practices to eliminate compliance risks.   

• Over 3.4 Million Documents Processed and Counting
• 8 Successful FDA, MHRA, and EMA Inspections
• 75% Risk Reduction
• 25+ Clinical Specialists Each Processing Over 100 Documents Daily
• 22 TMFs Rescued Mid-Study
• 10+ Years of TMF Stewardship
• 4,000+ Active TMFs
• Managed a 1.2 Million Document TMF
• DIA TMF Reference Model Committee Members