A complete guide to AI agents in clinical trials, includingwhat they are, the infrastructure they need, where people stay in charge, and how to start. Discover how agentic AI is transforming clinical trials, and what's next. And, learn about ontologies, human-in-the-loop governance, build vs. buy, continuous validation/governance, and more.

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According to seven different market research organizations, the “Agentic AI in clinical trials market” is expected to grow at a compound annual growth rate (CAGR) of anywhere between 12.5% to 43%. While the estimates obviously vary depending on who you ask, one thing remains crystal clear, agentic AI in clinical trials isn’t slowing down. As sponsors and CROs increasingly implement artificial intelligence, many organizations approaching clinical AI face real anxiety about the clinical trustworthiness of AI.

The ground has shifted for FSO (functional service outsourcing) and Unitized FSP (functional service providers) contract research organizations (CROs). 

For years, the playbook for managing these types of CRO economics was familiar. Sponsors negotiated rates while CROs managed headcount and utilization around those rates .

That playbook still holds true today in theory. However, the conditions underneath it have shifted enough that it no longer produces the results it used to. Funding is tighter, sponsors are smaller and more price-sensitive, timelines are compressing ahead of the patent cliff, and AI has moved from an experiment on the roadmap to a baseline expectation in every RFP.

None of that is unique to any one segment of the market, but these pressures land differently for FSO and unitized FSP providers than they do for full-service CROs. That’s because these businesses are built on rate cards for CRAs, monitors, and other functional resources. When sponsors squeeze rates or expect more output per unit, there's no broader program fee to absorb the hit, here the unit economics are the business.

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