AyurDatta today introduced Integrated High-Acuity Safety Governance (IHASG) — its operating model for physician-led, documented, inspection-ready safety oversight in AI-assisted and real-time clinical trials — alongside the Medical Oversight Workbench, a working tool that brings AI-speed narratives and grading together with mandatory physician adjudication and a Part 11-aligned audit trail.

"As the FDA's Real-Time Clinical Trials initiative and AI-driven pharmacovigilance compress every safety obligation a sponsor carries, the part that does not compress is benefit-risk judgment," said Dr. Ashok Srivastava, President and Chief Medical Officer. "IHASG is how we make that judgment fast enough for signal speed and documented by default."

The Workbench sits beside a sponsor's existing EDC and safety database rather than replacing them, and is the first module of a planned compliant, AI-driven unified safety platform. To see it on a case like your own, book a Readiness Assessment.