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TMF management doesn’t have to slow you down. Our full-time and on-demand TMF Study Owners have the expertise to reduce TMF risks and keep your clinical trial on track. Get TMF support with a flexible staffing model that extends your team’s capacity, scales with your clinical trial needs, and allows your study team to focus on patient recruitment and clinical trial operations.
TMF Completeness Checks
Audit and Inspection Readiness Preparation
eTMF Implementation and Process Consulting
eTMF Migration Support
eTMF Quality Control and Processing
TMF Storyboards
eTMF Audit Trail and User Access Management
eTMF Metrics, Reports, and Data Analysis
Our staffing solutions provide the freedom to adapt to the changes that every business experiences. Instead of lock-in contracts, you can adjust your TMF support needs to meet your dynamic study requirements.
Your study team will benefit from direct collaboration with expert TMF study owners. TMF management will be fully synchronized with your trial’s progress, ensuring tasks and deliverables stay aligned without the hassle of managing external resources.
Our TMF study owners handle the entire lifecycle of your Trial Master File, from study startup through to eTMF archive. Staffed TMF study owners can manage everything your TMF needs: TMF reviews, eTMF migration, global compliance, and more.
Minimize risks related to improper TMF maintenance or missing documentation. Your team will remain inspection-ready with tailored support.
Clinical trials are dynamic, and staffing needs can shift throughout the lifecycle of a study. Our team works on an on-demand basis, which means you get exactly the resources you need, when you need them—without having to commit to full-time hires.
Whether you’re experiencing resource constraints, have a hiring freeze in place, or just need help preparing for an upcoming inspection, our flexible staffing solutions maintain TMF health for 24/7 inspection readiness.
