October, 2024 – Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a strong pipeline of immune modulating antibodies, together with Flex Databases announce the successful implementation of Flex Databases’ Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solutions, including a new AI-driven feature for automated document filing and metadata assignment. This partnership goal for Agenus is improving efficiency, control, and compliance in its clinical trials.
Agenus selected Flex Databases after a thorough evaluation of several eClinical providers, and the decision was influenced by Flex’s commitment to innovation, speed, and customer service.
We asked CIO of Agenus Inc., Craig Winter, about his experience with Flex Databases:
What were the key factors that led Agenus to choose Flex Databases over other eClinical providers? Was it the technology, customer service, cost, or some other aspects?
“Flex worked much harder to win our business than the larger eClinical providers.
One example – In January we discussed the possibility of working with a 3rd party to use modern AI to auto-file documents submitted to our TMF. Flex reached out to the 3rd party. When Flex realized they couldn’t provide the integration in the timeline we would have required, Flex developed the capabilities natively at no cost to us, prior to us signing any contract.
A second example – We had a very tight timeline to implement our CTMS system. Other providers quoted over 20 weeks for a simple implementation, over 30 weeks with Study Startup and other modules we needed. Flex promised and delivered a 10 week implementation. To do this they started building our environment based on an LOI while contracts were still being negotiated. Despite having a full calendar, Flex worked around the clock including weekends to make sure our system was ready to go live when we needed it.
Despite having many clients (including several that are significantly larger than us), Flex has made us feel like we are their most important client. From a sponsors’ perspective this is rare and special”.
Is there any feature in Flex Databases’ CTMS and TMF that Agenus found particularly compelling?
“Flex’s CTMS and TMF offer all the features we found in other competing systems. We’re looking forward to utilizing Flex’s new AI eTMF feature which is more advanced than what we have seen with competing systems. Our clinical users with significant experience using the industry standard CTMS reported that Flex is more intuitive and faster to setup”.
What are challenges that Agenus was facing that led them to seek out a CTMS and TMF?
“Historically, Agenus has relied on our CROs to provide access to their CTMS and eTMF. Getting timely access to information has historically been a challenge and access to any information or reporting that wasn’t clearly defined in the original CRO contract involved long delays and costly change orders. In addition, we were at the mercy of our CROs since we didn’t control the systems that housed our data. Going forward all our trials will be run using a CTMS and TMF that we control. Flex’s straightforward per-user pricing model means we aren’t paying an additional fee for each trial, and we don’t have unbudgeted expenses if trials run longer than originally anticipated”.
How did implementation go, what is your opinion on Flex Databases support during and beyond implementation given your prior experience with us?
“I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done.
Flex support has been exceptional. One example:
Prior to implementing our sponsor owned system, our TMF was a Flex database run by a CRO. That instance didn’t include a feature we needed, and this went unnoticed by us for several years. When we did, we scheduled a joint call with Flex and our CRO. Flex immediately identified the issue. Within a week Flex completed the significant setup including validation without any change order or implementation cost”.
