On-Demand Expertise

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.

More than 40 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.

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 eClinical 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

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 TMF 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 

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

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.