Medidata and Sanofi Vaccines Extend Collaboration to Improve Patient Centricity

Collaboration will harness Medidata Electronic Clinical Outcome Assessment (eCOA) for remote patient engagement and real-time data capture

Medidata, a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, and Sanofi Vaccines, announced a collaboration to harness Medidata eCOA to deploy in vaccine studies. This builds on Medidata and Sanofi’s longstanding, successful experience using Medidata Rave EDC (electronic data capture).

“Expanding our collaboration with Medidata will enable us to improve our clinical development processes as we seek to deliver breakthrough vaccines to patients”

The collaboration will use an eDiary function within eCOA to create an eDiary library specific to Sanofi’s vaccines. This library will accelerate future study set-up times, improve efficiency, and increase data quality, while ensuring patients have access to eDiaries that are easy to use.

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Sanofi has chosen to adopt eCOA’s capabilities in its vaccine studies, optimizing the patient clinical journey by reducing on-site monitoring and allowing patients to input data in real time from any location. Pilots of eCOA were performed in six vaccine studies and demonstrated high levels of patient compliance, providing highly reliable data. As a result, the collaboration has since moved out of the pilot phase, with eCOA being deployed across a pipeline of Sanofi’s vaccine clinical trials.

“Expanding our collaboration with Medidata will enable us to improve our clinical development processes as we seek to deliver breakthrough vaccines to patients,” said the global head of clinical data management at Sanofi Vaccines. “Through a bespoke eDiary library, we can optimize eDiary set-up and improve data quality in current trials, while moving deeper into the digitalization era within the pharma industry.”

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Anthony Costello, chief executive officer, Medidata Patient Cloud, said, “At Medidata, we put the patient at the core of all of our work, and 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.”

Medidata eCOA is a full-service offering revolutionizing the way sponsors, contract research organizations, and sites collect data from patients, physicians, and caregivers. Built as part of the unified Medidata Platform, eCOA reduces study build times by up to 50% and provides a comprehensive view of patient data, while providing patients with flexibility and choice in how they engage in trial activities.

Sanofi has worked with Medidata for over a decade, leveraging Medidata’s solutions across the organization, including vaccine studies, to securely and efficiently capture and manage data.

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