Medable’s France CNIL Regulatory Breakthrough: Pioneering Global Clinical Trials

Medable has achieved a significant milestone by securing regulatory approval from France’s CNIL, enhancing its global clinical trial capabilities. Andrew Mackinnon, SVP and Executive General Manager at Medable, shares insights into this achievement, the rigorous process involved, and its broader implications for the clinical trials industry. This discussion highlights Medable’s innovative strategies and commitment to advancing digital solutions in global clinical trials.

Moe: The CNIL approval is a game-changer for Medable. What does this mean for France-based sponsors, and why is it significant?

Medable CNIL approval allows us to operate outside typical French data regulations, enabling collecting personal information like emails and names, which is crucial for e-consent. This is groundbreaking because it sets a precedent for future operations in France and globally, especially for French companies like Servier that apply these standards universally. This move underscores our commitment to innovation and leadership in navigating complex regulatory landscapes. By achieving this, we demonstrate our ability to adapt and lead in the evolving field of clinical trials, providing a model for others to follow.

Moe: What was the process for securing this approval, and what trials are you working on with Servier?

Securing CNIL approval involves a rigorous process initiated by the data controller, Servier. CNIL reviews submissions based on data security, minimization practices, and individual benefits. We showcased robust data protection, collected minimal necessary information, and highlighted e-consent benefits. The approval covers two global trials in phase two and three, part of Servier’s development program. This meticulous process illustrates Medable’s high standards, showcasing our dedication to maintaining data protection while advancing clinical research methodologies. Our commitment to secure and efficient data handling set a benchmark for future endeavors.

Moe: How does CNIL approval impact Medable’s business and benefit existing customers?

This approval is a testament to our robust data protection practices, providing confidence to our clients. It allows global customers to adopt e-consent in France, knowing we can secure necessary approvals. While the process is time-consuming, it assures clients we can operate within stringent regulatory frameworks, facilitating broader adoption of digital solutions in clinical trials. This approval also catalyzes other companies to explore similar pathways, knowing that Medable has paved the way, and reinforces our position as a trusted partner in the clinical trials industry, capable of navigating complex regulatory environments to deliver innovative solutions.

Moe: Are there similar international designations on Medable’s horizon, and what comes next?

CNIL’s framework is fairly unique, but we’re focused on removing barriers to adopting digital technologies in clinical trials globally. This includes ensuring compliance with various country regulations and facilitating smooth ethical submissions. While similar bodies may not exist elsewhere, we are committed to overcoming any adoption hurdles to expand clinical trial support globally. We take a proactive approach to understanding and integrating diverse regulatory requirements, ensuring that our solutions are compliant and optimized for efficiency and effectiveness in any region. This commitment to global accessibility is central to our mission.

Moe: You emphasize Medable’s commitment to global clinical research. What other actions has the company taken to advance this mission?

Our platform is available in 120 locales, ensuring broad global accessibility. Our team, rich in clinical research experience, understands regional and cultural requirements, enhancing our deployment strategies. Medable also has a diverse patient-caregiver network and site advisory council whose members guide the development of our solutions to ensure they meet patient, caregiver, and site needs. Additionally, partnerships like the one with Rare Patient Voice expand our reach in rare disease trials, furthering our global mission. This comprehensive approach ensures that we are meeting regulatory requirements and addressing the unique needs of diverse patient populations, thereby enhancing the inclusivity and effectiveness of clinical trials worldwide.

Moe: Medable has announced transformative improvements in its eCOA solution. Can you provide an overview of these enhancements?

The industry has shifted from proving the value of digital solutions to scaling it – as an example, we have seen 80% increase in enterprise adoption of eCOA at the portfolio-level compared to study-by-study contracts. The striking increase suggests rising industry confidence in the use of digital technology in clinical trials and a strategy shift from tentative, careful adoption to wide scale implementation across therapeutic areas, portfolios, regions, and even across the enterprise. Medable Studio facilitates this by simplifying study design and deployment, making innovation scalable. Our AI tools significantly reduce the time needed to build eCOA instruments and translations – in some early cases, slashing build times in half – and supporting global go-lives for trials. This scalability, plus trial build control, is crucial for expanding digital clinical trials industry-wide. By leveraging AI, we are enhancing efficiency and ensuring that our solutions are adaptable and responsive to the evolving needs of the clinical trials landscape, ultimately driving forward the digital transformation of the industry.