EpicentRx advances immuno-oncology research with greater operational scale

EpicentRx is a patient-driven immuno-oncology company based in La Jolla, California, focused on developing drug candidates designed to be effective across diverse patient populations while preserving quality of life.

As the company expanded its clinical research portfolio, the volume and complexity of trial documentation increased significantly. Supporting multiple studies at different stages required a more scalable and structured approach to Trial Master File (TMF) management.

When paper-based TMF systems slowed down progress

Prior to adopting a digital solution, EpicentRx relied on a paper-based TMF system.

While functional at a smaller scale, the approach made it difficult to maintain real-time visibility into document completeness, measure compliance efficiently, or support collaboration across distributed teams. Reviewing and filing documents required significant manual effort, slowing down overall study workflows.

As study volume increased, these limitations became more pronounced, creating a clear need for improved efficiency and centralized control.

“We were looking for a different way to increase efficiency while remaining compliant with the requirements of 21 CFR Part 11,” said Gina Varner, Director of Regulatory Affairs at EpicentRx.

Searching for a more connected TMF environment

EpicentRx evaluated multiple vendors before selecting Montrium’s eTMF Connect platform.

The decision was driven by the need for a cost-effective system that combined usability with strong TMF functionality, while also supporting compliance requirements and long-term scalability.

The team also valued the ability to implement a solution that could adapt to their workflows rather than forcing operational changes that would slow down study execution.

Moving from static files to real-time TMF intelligence

With eTMF Connect in place, EpicentRx transitioned from a paper-based structure to a centralized digital TMF environment.

Teams gained the ability to store, organize, and retrieve documents from a single system while maintaining clear structure aligned with TMF reference models. Real-time updates allowed stakeholders to track progress across studies without waiting for manual reconciliation.

Features such as TMF completeness tracking and structured placeholders immediately improved visibility into missing or misnamed documents, reducing uncertainty and manual oversight.

Strengthening collaboration and reporting across clinical teams

As adoption matured, EpicentRx saw clear improvements in both collaboration and operational efficiency.

Teams could now work concurrently across studies with real-time visibility into document status and progress. Search and filtering tools reduced the time required to locate specific TMF content, even across large volumes of documentation. Reporting capabilities also became more powerful through Excel export functionality, enabling deeper analysis of TMF health and study progress. This shifted reporting from a manual task to an on-demand capability.

At the same time, onboarding and training became more streamlined. New employees could quickly learn the system through help center resources, significantly reducing the learning curve compared to paper-based processes.

Impact summary

By implementing eTMF Connect, EpicentRx modernized its TMF management approach and improved real-time visibility across clinical trials. The organization increased operational efficiency, strengthened compliance oversight, and enabled faster, more scalable study management across a growing research portfolio.