Medable Eyes Expanded Presence in Europe with New Approval for Digital Trials

ACT: Medable has played a pivotal role in decentralized and digital clinical trials globally. How do you see the company expanding its presence further in Europe, specifically with this new approval?

Mackinnon: This is an interesting one because the new approval is highly relevant for global companies conducting work in France. That’s where most CNIL applications come into play.

This approval stemmed from our interaction with Servier. Companies like Servier consider CNIL regulations applicable to all their global operations, which is why we sought approval to operate in additional countries. To me, this approval unlocks significant potential.

We work with many companies looking to implement e-consent across their entire portfolio, believing it to be superior to paper. However, France has historically been a challenge due to CNIL regulations. As I mentioned, email is a core communication tool between medical staff and study participants. While we also use push notifications via a mobile app, I firmly believe email is the better pathway. Until now, CNIL regulations have been a barrier to this approach in French studies.

This approval doesn’t grant blanket authorization for all studies—each will still require individual approval. However, we now have confidence that CNIL has validated our medical processes. They’ve assessed our data security practices, GDPR compliance, and adherence to data minimization principles—ensuring we collect only the necessary personal information for each task. We met all these criteria. They also evaluated whether collecting this data benefits participants and determined our approach has a clear purpose.

On all three points, we met the standard and secured CNIL approval. This gives us greater confidence in operating within France, and we’re already in discussions with clients on how to replicate this approach. More broadly, this approval reinforces our commitment to data protection—a critical priority for pharma companies—and provides global validation of our processes.

Full Interview Summary: Key factors contributing to success include a strong customer value team with expertise in clinical research, not just technology. The team addresses product adoption, therapeutic area strategies, and patient engagement. A critical element for success is designing trials with patients’ daily lives in mind, ensuring that tasks are non-burdensome and easy to integrate into their routines. For example, in a study with patients suffering from extreme fatigue, notifications were adjusted to be more accessible by changing the timing to align better with patient habits.

Additionally, Medable has gained Canal approval for operating in France, overcoming previous barriers like stricter data protection regulations. This approval enhances confidence in using electronic consent (e-consent) across global trials, improving data security and participant benefits. Furthermore, advancements in AI and tools like Medical Studio are transforming trial operations. AI speeds up tasks like building eco instruments, reducing weeks of work to minutes, and offers solutions to challenges like language translation for global trials. With digital platforms, the company enables broader, scalable approaches for clinical trials across various therapeutic areas. This shift from pilot studies to large-scale implementations aims to enhance trial efficiency and cost-effectiveness across entire portfolios, rather than focusing on individual trials.

Lastly, regulatory bodies are adapting to decentralized trials, with the EMA and FDA releasing new guidelines that support the integration of digital solutions. Despite some regulatory discrepancies, such as the stricter Canal regulations in France, the industry is moving toward broader acceptance of decentralized trials, ensuring that digital tools are compliant with data security and privacy standards. This approach promises to reshape clinical trial methodologies, making them more efficient and accessible globally.