Why do you need to effectively manage your TMF?
Successfully managing your TMF is vital to ensure the success of your organization. Having a complete TMF supports business development activity (acquisitions and divestitures) in a more efficient manner. Additionally, newer technologies can actually improve operations by shifting the TMF from an archive to a supporting solution that is integrated into study start-up, drug shipment and other clinical processes. On the flip side, not having a complete and accurate TMF can result in observations (e.g., FDA 483), warning letters, delayed approvals and fines.
Choosing a partner to help improve your trial master file management is important in order to successfully improve your outcomes. CGI is the correct partner for four simple reasons:
- We have worked with more Sponsors than any other firm around trial master file management.
- Our team has extensive expertise around Trial Master Files
- Several are members of the TMF Reference Model (including Steering Committee)
- Diverse backgrounds including: Sponsor clinical, CRO clinical, and IT/system experience deploying/supporting TMFs
- We partner with all the top eTMF vendors, so we can help you determine which solution is best for your unique situation.