In February 2024 Medidata and Sanofi Vaccines announced a collaboration to “harness” Medidata’s eCOA (Clinical Outcome Assessment) for vaccine studies. This is the latest effort in a “longstanding, successful” relationship built using Medidata’s Rave EDC (electronic data capture). The eCOA “is revolutionising the way sponsors, CROs, and sites collect electronic data”. In this collaboration, the companies will use an eDiary function to create a library specific to Sanofi’s vaccines, accelerating future study set-up times, improving efficiency, and increasing the quality of data.
Medidata’s eCOA
Medidata states that eCOA is built with Designer, enabling users to build “rich patient experiences” through “intuitive” drag and drop screen templates and visual workflow tools. As part of the “unified” Medidata Platform, eCOA improves users’ study experience with “flexible deployment options, a groundbreaking global instrument library, and dedicated services and support”.
The era of digitalisation
By using eCOA Sanofi will improve the patient clinical journey through a reduction in on-site monitoring and by allowing patients to input data in real time from any location. In previous studies eCOA demonstrated “high levels of patient compliance” and provided “highly reliable data”. Therefore, the collaboration has moved out of pilot phase.
Sanofi’s global head of clinical data management is quoted suggesting that the expanded collaboration will enable the team to “improve” clinical development processes as they “seek to deliver breakthrough vaccines to patients”.
“Through a bespoke eDiary library we can optimise eDiary set-up and improve data quality in current trials, while moving deeper into the digitalisation era within the pharma industry.”
Chief Executive Officer at Medidata Patient Cloud is Anthony Costello, who emphasised “putting the patient at the core” of “all of our work”.
“Collaborating with Sanofi, who share this ethos, helps improve patient experience, the monitoring of patients in current studies, and accelerate study timelines and efficiencies in future studies.”
For more on revolutionising vaccine development processes at the Congress in Washington get your tickets now or subscribe here!
