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Case Study
Standardizing Clinical Trial Document Management with eTMF and eISF Lite
The Challenge
Founded in 1999, IFCT (Intergroupe Francophone de Cancérologie Thoracique, French Cooperative Thoracic Intergroup) is an independent, non-profit academic research intergroup specializing in thoracic oncology, with a mission to improve the survival and quality of life of patients with lung cancer. A global leader in lung cancer clinical research, IFCT operates across more than 300 investigator sites and works with over 600 physicians.
As a small clinical research organization, IFCT faced two interconnected problems that were putting both compliance and operational efficiency at risk. First, the heterogeneity of internal processes made it difficult to maintain consistency across trial master files (TMF) and investigator site files (ISF), creating gaps that threatened regulatory compliance. Second, the team was carrying a significant manual workload, particularly when handling substantial protocol amendments. With a large number of active sites, printing and distributing vast volumes of paperwork was not only time-consuming but also a persistent source of errors. Together, these challenges made it clear that a standardized, digital approach was no longer optional.
The Solution
IFCT conducted a thorough evaluation of four different solutions over nearly four years before selecting Trial Interactive.
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The decision to move forward with the eTMF and eISF Lite offering was driven by the need to improve quality and consistency across document processes, while remaining mindful of budget. The Lite version delivered the essential features required without unnecessary complexity.
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Onboarding was completed quickly, supported throughout by Trial Interactive's service desk, which played an important role in ensuring a smooth rollout. The platform's intuitive, user-friendly design helped ease the transition for the team and shortened the learning curve that inevitably accompanies any move to a new system.
The Impact
Once the team became comfortable with the platform, day-to-day work was meaningfully transformed. Document tracking improved, cross-site collaboration became more reliable, and audit trails became more robust, all of which directly strengthened inspection readiness.
The solution's built-in quality control processes enabled IFCT to identify and address inconsistencies more effectively, resulting in fewer errors and better compliance outcomes.The reduction in manual tasks, particularly around document distribution for site amendments, has already made a noticeable difference in accuracy and workload, and IFCT expects further efficiencies to emerge as processes continue to be optimized.