Clinical trial AI, Software-as-a-Medical-Device, and adverse event AI require FDA-grade constitutional governance. Deployable in days.
FDA requires complete Software-as-a-Medical-Device inventory with version control. AXIOM maintains the inventory automatically.
ICH E6 R3 requires traceability for AI use in clinical trials. AXIOM's immutable chain provides every data transformation's provenance.
Adverse event detection AI must be validated and auditable. AXIOM's 2,590 tests and constitutional versioning satisfy FDA GMLP requirements.
Every Software-as-a-Medical-Device tracked with version, approval status, and validation chain.
Every data transformation in clinical AI pipelines logged. Regulator-ready chain-of-custody.
Constitutional versioning aligned with FDA Good Machine Learning Practice. Audit trail satisfies inspections.
Clinical trial AI governance with FDA GMLP-aligned audit trail and auto-generated SaMD documentation. Your regulatory submission is always ready — not rushed.
Deploy constitutional governance for pharma AI in days. FDA GMLP.
USPTO #64/029,741 · SSRN #6523598 · In production since April 2, 2026