Medable Inc., a leading provider of clinical development technology, announced that its eConsent and eCOA solutions have been approved for use in two clinical studies in eight countries outside of the European Union by France’s Commission Nationale de l’Informatique et des Libertés (CNIL). This milestone makes Medable uniquely capable of operating as a data processor outside of the CNIL MR-001 Reference Methodology requirements for a France-based clinical trial sponsor. The achievement underscores Medable’s commitment to expanding access and providing secure, compliant, and scalable digital solutions for global clinical research.
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Medable partnered closely with Servier – one of the largest pharmaceutical sponsors in France – over six months to obtain CNIL approval. The team compiled an extensive dossier with platform validation documents, provided demonstrations and videos addressing security questions, and remained flexible in updating workflows and training materials through multiple CNIL revisions. Cross-functional collaboration and persistence across both companies earned the hard-won approval, expanding the use of Medable’s eConsent, eCOA, and other solutions.
“This approval is a testament to the strength of our platform and industry collaborations,” said Dr. Michelle Longmire, CEO and Co-Founder of Medable. “By combining regulatory expertise, compliance, innovation, and patient-centricity, we’re reshaping the future of clinical trials.”
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Medable has deployed its software-as-a-service platform in more than 300 decentralized and digital clinical trials in 70 countries, serving more than one million patients and research participants globally. Customers have achieved impressive results – including 90% eCOA adherence and 50% cost reductions. A Tufts CSDD study also shows that, on average, decentralized trials can achieve net financial benefits from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million ROI and $39 million ROI for an investment on average of $500K in Phase II and $1.5M in Phase III trials, respectively. Recently, the company launched Medable AI and Medable Studio to automatically convert outcomes assessments into fully digital eCOAs in seconds – now accessible on Google Cloud Marketplace.
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Source – businesswire
