Electronic Trial Master File Management

Companies in the pharmaceutical industry are required to maintain a trial master file (TMF) for each clinical trial they sponsor. An eTMF system based on standards allows computer system interoperability, seamless web-based document and record search, and electronic content archiving. However, companies are expected to interpret the guidance provided and develop a TMF management strategy based on their experience and technical expertise for effectively integrating document management processes with the way people work on a day-to-day basis.

How Can TAKE Solutions Help?

TAKE’s Regulatory Services team can provide strategic planning and support in implementing an electronic centralized method of compiling, storing and archiving the TMF documents. Our PharmaReady Document Management System is equipped with customizable Trial Master File Templates that capture searchable document metadata enabling instant access to all the stakeholders and document owners of the Trial Management.

The team is highly qualified to assist sponsors to organize and implement Trial Master Files to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and with applicable regulatory requirements. We provide guidance to file documents in an organized way that will facilitate management of the clinical trial, audit and inspection.

Products/Services

• eTMF Implementation Design
• eTMF Implementation & Roll-Out