Agentic AI

Combining artificial intelligence (AI) and agentic AI with electronic Clinical Outcome Assessment (eCOA) systems fundamentally enhances how clinical trial data is collected, interpreted, and acted upon. At its core, eCOA captures structured data directly from patients, clinicians, or observers, such as symptom severity, quality of life, or functional outcomes. Modern platforms expand this further by supporting a full range of assessment types, including electronic patient-reported outcomes (ePRO), clinician-reported outcomes (eClinRO), observer-reported outcomes (eObsRO), and performance outcomes (ePerfO).

‍

There's a particular kind of energy at the World Vaccine Congress that's hard to describe unless you've been in it. Hundreds of scientists, executives, policymakers, pharma leaders, CRO teams, and site networks, all in one convention centre, all sitting with the same fundamental tension. We know how to make vaccines that save lives. So why does getting them to patients still take so long?

I spent three days in Washington this week as part of the Medable team. Washington in late March meant that the cherry blossoms were just past their peak but still stunning, and catching them along the Tidal Basin between sessions was one of those small, unexpected gifts that a busy conference week doesn't always make room for.

For the conference, I came in with a clear intention. I wanted to reconnect with partners I respect, listen more than I talk, and have honest conversations about where this industry is and where it needs to go. What I didn't fully anticipate was how much the week would reinforce something I already believed but needed reminding of.

The urgency is real. And it's shared.

‍

eCOA has moved from a supporting tool to a foundational pillar of modern clinical trials, and Everest Group agrees. In its inaugural eCOA Products PEAK Matrix Assessment, Everest named Medable a Leader, citing strong market impact, accelerated timelines, and a platform built for real-world trial complexity. As the eCOA market surges toward nearly $1B in value, this recognition underscores how speed, patient experience, and AI-driven innovation are reshaping how trials are designed, launched, and scaled globally.

‍

Each January, the J.P. Morgan Healthcare Conference sets the tone for the life sciences industry, serving as the year’s most influential gathering of biotech, pharma, investors, and dealmakers. 

This year was no different. 

Thus, we checked in with our conference attendees, booth visitors, and more to see what they thought were this year’s trend-setting takeaways.

‍

The numbers are in, and they spell change for life sciences. 

That’s because nearly three-quarters (73%) of global pharmaceutical organizations are actively planning, piloting, or deploying agentic AI initiatives. 

This widespread means agentic AI is no longer a futuristic concept, but a present-day imperative for staying competitive and delivering life-changing medicines faster.

For those not yet in the know, agentic AI is a sophisticated form of AI designed not just to analyze data, but to act autonomously, plan, reason, and execute complex, multi-step tasks. This goes far beyond traditional automation. Instead, agentic AI is about creating intelligent systems that can drive innovation, accelerate drug development, and optimize operations like never before.

So, which companies are leading the charge, and how exactly are these intelligent agents reshaping the pharma landscape? Let's dive into the specifics.

‍

It’s been said that the only constant in the world is change. 

For decades, clinical trials have been a human only endeavor, with teams of clinicians, study teams, and patients working hand in hand to bring the latest molecules to market. Now, a new central actor has entered the clinical paradigm, agentic artificial intelligence. 

Only three years after OpenAI kicked off the artificial intelligence arms race, AI has gone from requiring users to prompt it, to pre-emptively identifying bottlenecks, safety risks, and more, thanks to agentic AI. 

Agentic AI is an autonomous, goal-oriented system that uses reasoning and external tools to independently plan, execute, and adapt multi-step actions with minimal human intervention to achieve complex objectives. 

Sponsors and CROs have begun using AI agents across their workforces to improve trials in ways that humans have traditionally struggled to accomplish. For instance, organizations have been creating AI agents to analyze prior trial protocols, benefiting from lessons learned across prior trials and real-world outcomes, enabling teams to anticipate risks and automating elements of submission drafting. Anomaly detection has helped teams better identify outliers in operational metrics or safety signals, prompting early interventions. Document intelligence accelerates medical writing by grounding generative outputs in verified data, which reduces cycle time without sacrificing accuracy. 

However, in each of these use cases, humans remain squarely “in the loop.” Or rather, the decision making isn’t left entirely to AI. Instead, the objective is to augment clinical, regulatory, and legal teams with tools that surface the right information at the right time.

This core concept, keeping a human in the loop, is essential to clinical decision making and operations as agentic AIs, while powerful, are not inherently suited to fully autonomous operation in all regulated contexts.

‍

The 2025 ESMO AI & Digital Oncology Congress, held in Berlin from November 12 to 14, highlighted the accelerating role of artificial intelligence across the oncology care continuum. Although imaging and pathology remain the most established fields for AI adoption, this year’s programming revealed a decisive shift toward workflow-integrated AI that enhances clinical operations, supports trial efficiency, and addresses the realities of patient monitoring. 

Across three days of sessions, side-room conversations, and industry demonstrations, one theme was clear. AI is evolving from experimental add-on technology into a practical clinical teammate, but scaling its impact will require robust validation, seamless integration, and a sustained focus on clinician trust.

‍

Discover how Medable’s AI-powered oncology platform simplifies complex cancer trials by integrating eCOA, ePRO, and eConsent solutions—reducing trial time, improving patient retention, and enhancing data quality for faster, more efficient research.

‍

Artificial intelligence continues to move from experimentation to execution across the life sciences industry. On a recent episode of the AI in Business podcast, Matthew Peruhakal, Global Head of Data Architecture, Utilization, and AI Engineering at Sanofi, offered a deep look at how the pharmaceutical giant is integrating AI to transform clinical trials. From intelligent data workflows to proactive risk detection and regulatory alignment, Peruhakal described an organization reshaping its research and development operations around a new digital core. 

His message was clear: AI cannot remain a side project. To make a meaningful impact, it must be embedded as a strategic capability that connects people, systems, and data across the enterprise.

‍

Artificial intelligence is shifting from promise to practice in biopharma, and few domains feel the impact more than clinical development. In a recent conversation on the AI in Business podcast, Zhong Lu, director of data science and AI at Novartis, outlined how AI is evolving the clinical trials process end to end. His perspective centered on building internal platforms that unite structured and unstructured data, deploying document intelligence to remove process friction, and using responsible generative AI to support scientific decision making without compromising compliance. While the regulatory bar remains high and patient trust is paramount, Novartis’s approach shows how targeted applications of AI can streamline data operations, strengthen regulatory readiness, and make both traditional and decentralized trials faster and more resilient.

‍

Explore how artificial intelligence (AI) is fundamentally transforming every facet of clinical trials, from initial protocol design and patient recruitment to data management and regulatory approval. This comprehensive guide provides an authoritative, in-depth look at AI's role in accelerating drug development and improving patient outcomes, with special focus on emerging agentic AI technologies.

‍