Agentic AI

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.

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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.

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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.

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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.

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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.

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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.

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It has become clear that our industry has reachedthe limits of human-only clinical development. As clinical trials have become increasingly complex, the endeavors that people alone can perform are no longer sufficient to generate the momentum needed to address the growing burden of human disease. This has led to longer drug development timelines and significant delays for patients. One large are of lost time is “white space,” definied simply as unproductive time caused by manual, sequential processes and fragmented data systems. Thankfully, a solution lies in agentic AI and its abilities to perform series of tasks.

Discover how Agentic AI is revolutionizing clinical trials by optimizing efficiency, accelerating drug development, and improving patient access to therapies.

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Agent Studio reimagines the clinical trial lifecycle, automating slow, manual processes, removing barriers in the clinical process, and introducing new ways to achieve clinical goals like never before. This first-of-its-kind, AI-powered, no-code platform lets you deploy ready-to-go agents trained as clinical development experts or create bespoke ones using your own data and expertise, unlocking endless possibilities.

In a rapidly changing research landscape, leaders at Takeda, Novartis, Sanofi, Daiichi Sankyo, and Medable share firsthand insights into how artificial intelligence is reshaping clinical trial operations.

This exclusive whitepaper explores how forward-thinking organizations are reimagining trial design, execution, and scaling to meet the demands of speed, precision, and patient-centricity across their entire portfolio.

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