See Zen Health on your own cases or trial protocols.
A 1-month evaluation pilot. Bring a sample of your historical safety cases (Zen Case AI) or test protocol authoring and feasibility simulation (Zen Protocol AI).
What you get from the pilot
Case Quality Score & Domain Findings
Detailed defect analysis across the 7 safety domains with case quality scoring (0–100) and MedDRA validation.
Reviewer Acceptance & Time Velocity
Acceptance rates for AI candidate findings and measured review time reduction against your historical baseline.
ICH M11 Structured Protocol Package
Automated authoring or legacy conversion across 133 ICH M11 sections with cross-section dependency impact tracking.
Monte Carlo Feasibility & PoS Dossier
Vectorized Poisson-Gamma accrual simulation delivering P10/P50/P90 enrollment timelines and sensitivity bottleneck levers.
Inspection-Grade Audit Evidence
Full 21 CFR Part 11 append-only audit trail logs with electronic signature manifestations and provenance records.
Request a pilot
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