TMF Migration and Consulting Case Study

Background and Challenge

A biotech company engaged LMK Clinical Research Consulting for support with a Trial Master File (TMF) migration from another eTMF vendor to TI. The scope included consulting hours as a contingency. The client’s primary point of contact, lacked TMF and clinical operations experience. Combined with poor CRO performance, this created delays and heightened anxiety around project execution.

Solution

An LMK consultant provided hands-on project support, including drafting essential communications to drive CRO engagement and facilitate smooth collaboration across all parties. This guidance helped stabilize the project and kept progress on track despite early challenges.

Results
The engagement began with 60 consulting hours. Following the TMF assessment, LMK recommended an additional 100 consulting hours, initially considered optional but ultimately essential for success. LMK’s consultant ensured consistent progress, reduced client stress, and helped deliver a complete and compliant TMF migration.