How this biotech improved collaboration and accurate reporting with eTMF Connect

To meet patients’ critical unmet needs and provide innovative drug solutions, the EpicentRx team was looking for alternative ways to be more efficient with their trial master file (TMF) management. Since working with Montrium’s eTMF Connect for over one year, EpicentRx has seen heightened efficiency and productivity with the increased organization of data and records, the use of TMF data reporting features, and enhanced collaboration amongst sites and study teams.

The customer: EpicentRx is a patient-driven immuno-oncology company with headquarters in La Jolla, California. Their research and development activities surround drug candidates that work effectively and broadly across diverse patient populations and tumor types, and are minimally toxic to preserve the patient’s quality of life.

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Challenge: Working in a paper-based TMF made collaboration, review of documents, and measuring performance and compliance difficult, requiring a significant amount of time and resources to maintain.

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Solution: The transition to Montrium’s eTMF Connect improved collaboration and accurate reporting, allowing for increased productivity and efficiency within a central application.

Previously, the EpicentRx team utilized a paper-based TMF which challenged the existing team and prevented scalability. As stated by Gina Varner, Director of Regulatory Affairs at EpicentRx, “Managing and filing in the paper TMF was too slow-moving, and it was also difficult to have a real-time assessment of completeness of TMF.” The EpicentRx team was looking for a different way to increase efficiency while remaining compliant with the requirements of 21 CFR Part 11.

EpicentRx went through a full vendor selection process and evaluated several other software platforms. Montrium stood out compared to other products as eTMF Connect was cost-effective and provided a user-friendly interface with powerful TMF capabilities.

Gina Varner, Director of Regulatory Affairs at EpicentRx shares, “The product came with a good support team that could work with our particular needs to implement thesoftware in a way that would work best for us,” adding, “eTMF Connect has been worth the financial investment, we have become more efficient with our staff resources and maintaining the TMF, and can take on new projects without adding significant time and costs.”