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Genira
Explainable AI for medical coding & adverse event classification

AI Governance Hub

The control plane for every AI decision in your safety and clinical workflow — explainable, validated, audit-ready.

Track every AI prediction with model lineage, confidence scoring, human override, and revalidation triggers. Aligned with EU AI Act, FDA SaMD, and ICH GCP E6(R3) expectations for AI governance in pharma.

What you get

Per-decision explainability and model lineage

Human-in-the-loop override and revalidation

Drift monitoring and retraining triggers

Aligned with EU AI Act & FDA SaMD guidance

Audit-ready evidence pack export

Centralized policy across PV, EDC, eQMS

Ready to consolidate your eClinical stack?

Talk to us about a 30-minute scoping call. No deck. Just product and your real workflow.