Sanofi Vaccines has entered into a collaboration with clinical trial solutions provider Medidata to use Medidata’s electronic clinical outcome assessment (eCOA) in its vaccine studies.
This new partnership is an extension of the longstanding relationship between the two companies for the use of Medidata Raven electronic data capture (EDC).
The latest alliance aims to create an eDiary library in eCOA that is tailored to Sanofi’s vaccines, which will expedite the setup of future trials, enhance efficiency, and ensure high data quality.
In addition, the eDiaries are designed to be user-friendly for patients.
Sanofi’s adoption of eCOA in its vaccine trials is a strategic move to optimise patients’ clinical journeys by minimising on-site monitoring and enabling real-time data input from any location.
Pilot studies of eCOA in six vaccine trials have shown high levels of patient compliance and the delivery of highly reliable data.
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Following the success of these pilots, eCOA is now being implemented across a range of Sanofi’s vaccine clinical trials.
Medidata eCOA aids sponsors, contract research organisations (CROs), and sites in collecting data, reducing study build times by up to 50%, and providing a comprehensive view of patient data.
Medidata’s eCOA is part of the unified Medidata Platform, which offers flexibility and choice for patients participating in trial activities.
This latest development follows Medidata’s launch of its new data integration solutions, Clinical Data Studio and Health Record Connect, aimed at accelerating clinical trials.
These solutions are designed with an open, interconnected, and scalable data architecture to enhance and optimise clinical data workflows.
Sanofi Vaccines clinical data management global head said: “Expanding our collaboration with Medidata will enable us to improve our clinical development processes, as we 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.”