Case Study: EpicentRx achieves streamlined TMF management and increased efficiency with Montrium's eTMF Connect

EpicentRx - Customer Case Study

EpicentRx, a patient-driven immuno-oncology company based in La Jolla, faced scalability and compliance challenges from a paper-based trial master file (TMF) that made collaboration slow and prevented real-time assessment of TMF completeness under 21 CFR Part 11. To modernize their TMF management, EpicentRx selected Montrium’s eTMF Connect.

Montrium implemented eTMF Connect as a centralized, DIA Reference Model–aligned platform with real-time tracking, robust search/filtering, Excel export for reporting, and collaborative workflows. The solution markedly improved productivity and organization—dramatically reducing time previously spent filing and locating documents, enabling management of a larger volume of studies, improving TMF health visibility, and delivering ongoing support and training from Montrium.

EpicentRx

Gina Varner

Director of Regulatory Affairs