Review faster.
Defend every decision.
Zen Case AI is pharmacovigilance case software built to turn complex safety cases into structured, review-ready intelligence.
Automate triage. Accelerate MedDRA coding. Score case quality. Generate narratives. Keep every action attributable and auditable.
AI for medical review. Built for regulated workflows.
For Pharmacovigilance Teams · Sponsors · CROs · Safety Operations
Medical review, rebuilt for modern pharmacovigilance.
Zen Case AI combines AI-assisted review with deterministic workflows and audit-ready controls.
Find what matters faster.
Automatically review incoming safety cases and prioritize them for human assessment.
Triage → Prioritize → Review
Code with clinical context.
Navigate the MedDRA hierarchy with AI-assisted coding recommendations designed to support consistent medical review.
LLM-assisted. Human-approved.
Know the quality before you sign.
Every case receives an objective 0–100 quality score based on defined review criteria.
Detect gaps. Fix them. Measure improvement.
From case data to review-ready narrative.
Generate structured regulatory narratives from case information and clinical context.
Draft faster. Review smarter. Approve with confidence.
Built for regulated workflows.
Electronic records need more than an AI model. Zen Case AI supports 21 CFR Part 11 requirements through controlled electronic records, attributable actions, and electronic signatures.
Dual Electronic Signatures
Require independent review and approval with two electronic signatures.
Append-Only Audit Trails
Create a persistent record of actions and changes.
Attribution
Know who performed an action and when.
Review & Approval
Keep human oversight at the point of regulatory decision.
AI assists. Authorized users approve.
From intake to approval.
Ingest
Bring the safety case into the workflow.
Triage
AI identifies and prioritizes case signals.
Code
Review MedDRA coding recommendations.
Score
Measure case quality from 0–100.
Generate
Create a structured regulatory narrative.
Review
Qualified users inspect and refine the case.
Sign
Complete controlled dual electronic signatures.
Audit
Maintain an append-only record of activity.
AI accelerates the work. Humans own the decision.
Zen Health is designed around a simple principle:
AI
Triage · Recommend · Draft · Explain
Deterministic Controls
Validate · Score · Record
Medical Reviewers
Review · Approve · Sign
Intelligence without surrendering control.
Faster review. Stronger evidence.
Built for pharmacovigilance
Purpose-built workflows for safety case review.
Measurable quality
Turn case quality into a visible, trackable signal.
Regulatory-ready controls
21 CFR Part 11 electronic signatures and append-only audit trails.
Human-in-the-loop
AI supports reviewers without replacing accountable medical judgment.
Traceable by design
Every important action leaves an attributable record.
Safety teams operating at scale.
Pharma & Biotech
Standardize safety review across products and teams.
CROs
Increase review capacity while maintaining process consistency.
Pharmacovigilance Teams
Reduce manual effort across high-volume case workflows.
Medical Reviewers
Spend less time navigating workflows and more time making clinical decisions.
Your safety workflow deserves better intelligence.
Accelerate ICSR review with PV case software designed for AI-assisted medical review, measurable quality, and 21 CFR Part 11 controls.
Zen Case AI
Pharmacovigilance case software built for regulated pharmacovigilance.