With the right blend of people, processes, and technology, we keep your TMF inspection-ready!
We expertly manage your TMF, minimizing your operational burden and ensuring compliance throughout your trial!
We offer a fast and customized TMF setup and ongoing management to guarantee quality, completeness, and timeliness.
With the right blend of people, processes, and technology, we keep your TMF inspection-ready!
We expertly manage your TMF, minimizing your operational burden and ensuring compliance throughout your trial!
We offer a fast and customized TMF setup and ongoing management to guarantee quality, completeness, and timeliness.
concurrent studies managed by our experienced TMF team
paper TMFs (pTMFs) successfully managed
electronic TMFs (eTMFs) completed
filed documents in our in-house eTMF system, operational since 2011
with zero audit or inspection findings, clear proof of our commitment to quality and compliance.
100% satisfaction rate (rated at least 9.5/10) over the last 3 years.
At GCP-Service, our TMF specialists ensure meticulous oversight, fast setup, and ongoing quality control using paper and our cost-effective eTMF/QCTMS™ platform. We deliver full traceability, real-time metrics, and ALCOA-compliant document management, keeping your Trial Master File inspection-ready throughout the study lifecycle.
We use the TMF Reference Model as a foundation and align it with regulatory requirements to design a trial-specific TMF that meets each client’s unique needs.
An intuitive and cost-effective eTMF solution, QCTMS TMF is built to fully comply with regulatory standards—including audit trails, role-based access, and inspection readiness. It offers robust study oversight and efficient record management tools.
A standout feature is its integrated electronic Investigator Site File (eISF), designed to streamline collaboration and elevate your clinical trial operations.
As active members of CDISC and the TMF Reference Model Group, we stay at the forefront of industry innovation, contributing to and applying the latest standards in clinical trial records management.
With deep regulatory expertise and a commitment to long-term collaboration, our TMF specialists provide consistent, compliant, and proactive support, ensuring your study stays inspection-ready from start to finish.
Our team works with a variety of eTMF solutions, including major industry platforms as well as our own in-house TMF system for a more cost-efficient approach.
Partner with us for compliant Trial Master File management and accurate clinical data handling, ensuring audit readiness and smooth clinical trial execution.
Partner with us for compliant Trial Master File management and accurate clinical data handling, ensuring audit readiness and smooth clinical trial execution.
