Agenus Inc. (NASDAQ: AGEN), a leader in immuno-oncology with an extensive pipeline of immune-modulating antibodies, has successfully implemented Flex Databases' Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solutions, featuring a cutting-edge AI-driven functionality for automated document filing and metadata assignment. This strategic collaboration aims to streamline efficiency, control, and compliance across Agenus’ clinical trials.

Agenus selected Flex Databases following a rigorous evaluation of various eClinical providers, with Flex’s dedication to innovation, fast deployment, and superior customer service standing out as decisive factors.

Craig Winter, CIO of Agenus Inc., shared his experience in choosing Flex Databases over other providers:

“Flex worked much harder to win our business than the larger eClinical providers. In January, we explored an AI-driven document auto-filing capability. Flex quickly reached out to a third-party provider, and when it became clear the timeline wouldn’t work, Flex developed this capability internally at no cost to us, even before a contract was signed.

Additionally, we had a tight timeline to implement our CTMS system. While others quoted over 20 weeks for a basic setup, Flex promised and delivered in 10 weeks, starting work on an LOI while contracts were still being finalized. Despite a demanding schedule, Flex prioritized our go-live date, even working weekends to ensure readiness. They made us feel like we’re their most important client, which is rare and valuable for us as a sponsor.”

When asked about Flex Databases' features that stood out, Winter highlighted:

“Flex’s CTMS and TMF encompass all the key functionalities found in other systems, with a new AI eTMF feature that surpasses competitor capabilities. Our clinical team has found Flex's system more intuitive and faster to set up than industry-standard CTMS.”

Reflecting on the challenges Agenus faced prior to implementing a dedicated CTMS and TMF, Winter noted:

“Previously, we depended on CROs for CTMS and eTMF access, which resulted in delays and costly adjustments whenever additional access or data was required. Moving forward, we will run all trials using a CTMS and TMF that we control. Flex’s clear per-user pricing structure also ensures we avoid unplanned costs, even for extended trials.”

Discussing the implementation process, Winter praised Flex’s support:

“With over 26 years at Agenus, I can say Flex’s CTMS and TMF implementation was the smoothest and fastest we’ve seen for a validated IT system. Their support has been exceptional, resolving a long-standing configuration issue with our CRO-run TMF instance promptly and without extra costs.”

This successful collaboration highlights Flex Databases’ commitment to supporting sponsors like Agenus with cutting-edge, responsive, and client-focused eClinical solutions.