Medable Secures CNIL Approval, Paving the Way for Digital Clinical Trials in the EU
Medable Inc., a global leader in clinical development technology, has reached a significant regulatory milestone with the approval of its eConsent and electronic Clinical Outcome Assessment (eCOA) solutions for use in two clinical studies across eight countries outside the European Union. This approval was granted by France’s Commission Nationale de l’Informatique et des Libertés (CNIL), marking a crucial step in Medable’s mission to expand access to secure, compliant, and scalable digital solutions for global clinical research.
This achievement positions Medable as a uniquely capable digital technology provider, operating as a data processor outside of the CNIL MR-001 Reference Methodology requirements for clinical trial sponsors based in France. By obtaining this approval, Medable is reinforcing its commitment to regulatory excellence, patient-centric innovation, and the transformation of clinical trial accessibility worldwide.
A Collaborative Effort in Regulatory Approval
Medable’s success in obtaining CNIL approval was the result of a rigorous six-month collaboration with Servier, one of France’s largest pharmaceutical sponsors. The process involved compiling an extensive dossier containing platform validation documents, security demonstrations, and workflow training materials. Medable’s team provided detailed videos to address security-related questions and adapted their workflows in response to multiple CNIL revisions. This iterative and cross-functional collaboration between Medable and Servier played a pivotal role in securing the regulatory green light.
Dr. Michelle Longmire, CEO and Co-Founder of Medable, emphasized the significance of this approval, stating, “This approval is a testament to the strength of our platform and industry collaborations. By combining regulatory expertise, compliance, innovation, and patient-centricity, we’re reshaping the future of clinical trials.”
The ability to navigate stringent regulatory processes and obtain CNIL approval demonstrates Medable’s dedication to ensuring compliance while accelerating the adoption of digital clinical trial technologies. The company’s regulatory success is expected to encourage broader adoption of decentralized trial methodologies, benefiting sponsors, researchers, and patients alike.
Medable’s Impact on Digital and Decentralized Clinical Trials
Medable has established itself as a key enabler of digital and decentralized clinical trials (DCTs), deploying its software-as-a-service (SaaS) platform in more than 300 trials across 70 countries. With over one million patients and research participants engaged globally, Medable’s platform is proving its value in improving trial efficiency, reducing costs, and enhancing patient outcomes.
The company’s digital solutions have driven significant results, including a remarkable 90% adherence rate to eCOA protocols and cost reductions of up to 50% for clinical trials. Such improvements are critical for pharmaceutical and biotech companies striving to optimize clinical trial operations, accelerate drug development timelines, and enhance patient engagement.
A recent study conducted by the Tufts Center for the Study of Drug Development (CSDD) further supports the financial advantages of decentralized trials. The study found that decentralized trial methodologies can deliver net financial benefits ranging from five to 13 times the initial investment for Phase II and Phase III trials. Specifically, for an average investment of $500,000 in Phase II trials, sponsors could realize a return on investment (ROI) of approximately $10 million. In Phase III trials, an investment of $1.5 million could yield an estimated $39 million ROI. These findings underscore the transformative potential of decentralized clinical trial technologies in reducing costs and improving efficiency across the drug development lifecycle.
Advancing Digital Innovation with Medable AI and Medable Studio
In line with its commitment to continuous innovation, Medable recently launched Medable AI and Medable Studio, cutting-edge platforms designed to revolutionize clinical trial execution. Medable AI leverages artificial intelligence to streamline data collection, enhance predictive analytics, and automate key trial processes, making clinical research more efficient and scalable. Meanwhile, Medable Studio enables the rapid conversion of outcome assessments into fully digital eCOAs within seconds, reducing administrative burdens and ensuring seamless integration into clinical trial workflows.
These advancements have positioned Medable as a leading force in the evolution of clinical research, further enabling pharmaceutical sponsors, contract research organizations (CROs), and regulatory bodies to embrace digital transformation. By making eCOA solutions readily available on Google Cloud Marketplace, Medable is expanding accessibility to its technology, ensuring that clinical trial sponsors can deploy and scale digital solutions with greater ease.
The Significance of CNIL Approval for Global Clinical Trials
The approval from CNIL carries substantial implications for Medable and the broader clinical research community. CNIL is one of the most stringent data protection and privacy regulators in the world, and securing approval from this body signals that Medable’s digital solutions meet the highest standards of security, compliance, and data integrity.
For pharmaceutical companies conducting trials in France and other regulated markets, this approval provides assurance that Medable’s platform aligns with the latest regulatory requirements. It also paves the way for further expansion of digital clinical trials into additional jurisdictions where data privacy regulations are increasingly strict.
The ability to operate as a data processor outside of the CNIL MR-001 Reference Methodology requirements provides Medable with a strategic advantage, allowing it to support France-based clinical trial sponsors while complying with international regulatory frameworks. This flexibility is particularly valuable in an era where regulatory harmonization and cross-border collaboration are essential for accelerating medical innovation.
Future Outlook: Expanding Global Access to Digital Trials
Medable’s achievement in securing CNIL approval represents just one milestone in its broader mission to expand global access to digital and decentralized clinical trials. The company continues to invest in research and development, regulatory partnerships, and innovative technology solutions to address the evolving needs of the clinical research landscape.
As the industry moves toward more patient-centric and technology-driven trial methodologies, Medable is well-positioned to lead the transformation. The combination of advanced AI-driven platforms, regulatory expertise, and a strong focus on patient engagement ensures that Medable will remain at the forefront of clinical trial innovation.
Looking ahead, Medable plans to further enhance its digital trial capabilities by integrating additional AI-powered tools, expanding partnerships with global pharmaceutical sponsors, and advocating for regulatory frameworks that support the widespread adoption of digital health technologies.
