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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.
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.
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.
Our career TMF experts can provide you with tools and guidance for ensuring completeness and compliance and help you successfully navigate regulatory scrutiny.
Mock Inspection Support
Regulatory Agency Inspection Support
Process Training Materials
Completeness and Review Checks
ICH/GCP Review Checks
Inspection Readiness and Preparation Workshops
Needs Assessment Workshop
Sponsor Oversight Requirements Workshop
eTMF Requirements and Specification Workshop
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.
Scalable resources and proven methodology to ensure completeness and compliance
Supplementary TMF process and/or expertise for inspection readiness preparation
Growth in internal expertise and knowledge
Over 5 Million Documents Processed and Counting
Successful FDA, EMA, MHRA, PMDA, GCP Inspections
Over 75% Risk Reduction
200+ Clinical Specialists Each Processing Over 100 Documents Daily
40+ TMFs Rescued Mid-Study
12 Years of TMF Stewardship
6,000+ Active TMFs
Managed a 1.2 Million-Document TMF
DIA TMF Reference Model Committee Members