When Your CRO's AI Sends a Query, Who's Accountable for the Answer?

ICON, the largest CRO, has partnered with Anthropic to deploy Claude AI across clinical trial operations, raising critical data governance and compliance questions for clinical sites about AI-generated queries and their audit trail. Sites must secure written compliance confirmation, update SOPs for AI query handling, and engage compliance officers to prepare for regulatory scrutiny under FDA draft guidance and ICH E6(R3) standards.

This Wire brief sits within Fusion42's coverage of Health.