During clinical trial, we are required to create and maintain a Trial Master File (TMF) containing up to 100s of thousands (and some times millions) of clinical documents. These documents are designed to demonstrate compliance to an investigator or sponsor, and to prove that GCP standards were upheld.
With the emergence and early adoption of electronic TMF tools (eTMF,) the industry is now able to maintain ownership and monitor the TMF in real-time, even if they utilize multiple CRPs. Through proper monitoring of the TMF, you will be able to view the quality of the data produced with the ultimate goal of monitoring CROs and demonstrating compliance for the sponsors, CROs, investigators, and other stakeholders.
At ExL Pharma’s 3rd Trial Master File Summit, TMF experts will discuss best practices for developing, managing, and monitoring a TMF process that is regulatory compliant for audits and inspections. TMF Process Owners, Quality Assurance, Clinical, Regulatory, and Information Technology professionals who are responsible for TMGF will share insights and best practices to facilitate successful TMF management.
This conference is designed for professionals from pharmaceutical, biotech, medical device, and clinical research organizations with responsibilities in the following areas: