On the 11th Day of Christmas in Discover Pharma’s industry outlook series, Medable said 2026 will mark a turning point for clinical research as agentic AI systems move from limited experimentation into routine use across clinical trials, regulatory review, and drug development operations.

The privately held digital health company, which provides an AI-enabled clinical trials platform, expects increasing autonomy for AI agents within trial workflows, alongside clearer regulatory frameworks that allow innovation while maintaining human oversight. The outlook forms part of a paid campaign and reflects Medable’s assessment of where the sector is heading, rather than new clinical data or policy announcements.

Clinical development remains constrained by manual processes and fragmented workflows, Medable said, with mounting pressure on clinical research associates as trials become more complex and globalised.

Michelle Longmire, CEO and co-founder of Medable, said operational burden continues to slow trial delivery and contribute to workforce strain.

Longmire said: “Clinical development is bottlenecked by manual processes. Clinical Research Associates are overworked, often experiencing burn out.”

She added agentic AI could begin to address inefficiencies by taking on administrative and coordination tasks that currently consume significant trial capacity.

“In 2026, Agentic AI will unlock the keys for improved clinical development, starting by alleviating within trial white space and empowering clinical research associates to focus more on sites and the trial operations rather than administrative tasks,” Longmire said.

According to Longmire, the next phase of adoption will require clearer measures of performance and accountability, particularly as AI systems move beyond narrow task execution.

“To achieve value, agents must be measured against the outcomes they deliver, including end-to-end autonomy,” she said, adding that AI systems will begin to deliver high-value components of the development lifecycle while operating with human oversight for critical activities.

Alongside operational change, Medable expects regulatory governance of AI to mature significantly over the next 18 months.

Pamela Tenearts, chief medical officer at Medable, said 2026 would represent a regulatory inflection point for AI in clinical research.

“Next year will be an inflection point for how AI is governed in clinical research,” Tenearts said.

She pointed to progress by both FDA and EMA toward more aligned and forward-looking approaches, including the implementation of the EU AI Act in the first half of 2026 and the increasing use of generative AI tools within regulatory agencies.

According to Tenearts, regulators appear increasingly comfortable with a tiered approach to AI autonomy, where lower-risk research activities can be automated with fewer constraints.

“In 2026, there will also be a tiered approach to autonomy,” she said, adding that strong human control will remain essential for decisions affecting safety, ethics, and public trust.

She also said international coordination between regulators could help ensure AI governance evolves alongside the technology. “The challenge, which we cannot underestimate, is to ensure that the governance, safeguards, and ethical commitments evolve as quickly as the technology they aim to oversee.”

From an R&D perspective, Medable expects agentic AI to drive a shift away from linear development models toward continuously learning pipelines.

Andrew Mackinnon, global executive general manager at Medable, said the change would be structural rather than incremental.

Mackinnon said: “2026 will feel less like a ‘slow-pipelines’ world and more like a ‘smart-pipelines’ world.”

He said agentic AI systems could increasingly support hypothesis generation, protocol optimisation, safety monitoring, and cross-functional coordination, allowing researchers and clinicians to move into higher-value oversight roles.

“Humans won’t be removed from the process – they’ll shift into higher-value oversight roles,” Mackinnon added, describing a pipeline that is faster, more adaptive, and increasingly self-optimising.

Medable said it expects these changes to support more efficient drug development and broader patient access, while acknowledging that sustained regulatory alignment and robust governance will determine how quickly agentic AI is adopted at scale.