Analysis from Bourne Partners says lack of regulatory clarity is slowing AI adoption across the clinical trials ecosystem, including sponsors and contract research organizations. The report argues that sponsors are hesitant to deploy AI-enabled workflows without finalized FDA guidance, which could unlock broader use once formal expectations are clear. The bottleneck points to practical questions around validation, oversight, and how AI outputs should be governed across regulated study operations. Until that framework is completed, many organizations appear to be delaying implementation even when AI tools can streamline trial execution. For the biotech industry, the development reframes AI from a pure capability challenge to a regulatory readiness issue, with timing risk tied to when guidance becomes enforceable and auditable.