Addressing Clinical Trial Challenges Through AI and Scalable Solutions

ACT: What advancements do you foresee for Medable AI and Medable Studio, and how might these innovations change the way clinical trials are conducted in the coming years?

Mackinnon: We designed Medable Studio to scale clinical trial approaches across an entire company, enterprise, portfolio of work, and development asset. That’s one of the key ways we see growth happening. Up until now, we’ve conducted many pilot studies—companies would run a single study to test the approach. We’ve done a lot of those, and we’re now seeing the value they bring. We understand that operating trials this way offers significant benefits but scaling it across multiple trials has been a challenge. However, we’re now seeing companies adopt this approach more broadly.

This isn’t something limited to one or two trials or reserved for Phase IV studies—it’s a model that can be applied across all trials. It enables us to scale in ways that weren’t possible before. Traditionally, scaling innovation required significant human resources, almost like a tax or capital investment. Medable Studio eliminates that burden, making innovation more efficient.

AI further enhances these capabilities. We’ve already integrated AI into some of our tools. For example, building eCOA instruments—a process that once took weeks—now takes minutes, sometimes even seconds. That’s a significant advancement, but it only scratches the surface. Once an instrument is in the library, it never needs to be built again.

We’re also tackling translation, which has been a major bottleneck in running global trials. Eliminating that barrier will bring enormous benefits. Leveraging AI-powered translation tools will further streamline the process.

Beyond these efficiencies, AI is reshaping how clinical trials are conducted. It’s not just about collecting data through eCOA—it’s about passive data collection via sensors and wearables, enabling remote, large-scale monitoring. Additionally, integrating with EHR systems and tokenization vendors allows us to gather richer patient data and answer research questions in new ways. These innovations are fundamentally changing the clinical trial landscape.

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.