Reliable accuracy till the last page.
The Trial Master File contains essential documents for a clinical trial which may be subject to regulatory agency oversight. Bearing this in mind, our Record Management team ensure a comprehensive, proactive and efficient approach to the design and operational maintenance of this key document repository.
The Trial Master File (TMF) can potentially contain thousands of documents and records requiring organisation and maintenance. Further complicating matter is the input from countless vendors, particularly in large, global studies. With Accelsiors systems and processes driving the management of key clinical trial documents you will experience real-time inspection readiness, visibility and control. Our centralised Record Management team is dedicated to ensuring robust and proactive management of the study TMF. Their efforts are supported by our eTMF platform, Accelsiors Document Access Management system (ADAM), a web-based application to enable ready access to all study documentation. Electronic signature capability further increases productivity across the organisation. File structures are based on the TMF Reference Model, allowing direct access to support remote audit, inspection, and monitoring.
WE ARE CONSCIOUS OF THE IMPORTANCE OF:
- Clear document management planning, especially during the critical start-up phase of a project;
- Comprehensive team training;
- Proactive document management and feedback.
RECORD MANAGEMENT SERVICES:
- Record Management Plan development;
- TMF/eTMF set up and maintenance;
- Compliance reporting.