Clinical Intelligence.
Built For Modern Clinical Trials.
Zen Health brings medical review and clinical trial intelligence into one enterprise platform.
Two products. One intelligence layer.
For Sponsors · CROs · Safety Teams · Clinical Development
Two Systems For The Work That Matters.
Zen Case AI
Medical review intelligence for pharmacovigilance.
Turn complex safety cases into structured, review-ready intelligence.
- Automated ICSR triage
- MedDRA coding hierarchy
- Case quality scoring
- Regulatory narrative generation
- 21 CFR Part 11 electronic signatures
- Append-only audit trails
Zen Protocol AI
Protocol authoring and feasibility intelligence for clinical trials.
Build standardized protocols. Compile eligibility criteria. Model enrollment before the trial starts.
- ICH M11 protocol authoring
- PDF / DOCX legacy conversion
- Deterministic eligibility criteria compiler
- Monte Carlo feasibility simulation
- Probability of Success
- P10 / P50 / P90 completion forecasts
Less Guesswork. More Evidence.
Clinical operations shouldn't depend on opaque AI or static spreadsheets. Zen Health combines:
AI
Proposes. Drafts. Explains.
Deterministic engines
Validate. Compile. Enforce.
Statistical simulation
Calculates. Forecasts. Quantifies.
Human experts
Review. Decide. Sign.
AI assists. Humans decide.
Medical Review, Engineered For Defensibility.
Zen Case AI gives pharmacovigilance teams a structured intelligence layer for every case.
Triage
Automated ICSR triage and prioritization.
MedDRA
Hierarchy-aware coding with clinical context.
Quality
Objective case quality scoring from 0–100.
Narratives
Generate structured regulatory narratives for review.
Compliance
21 CFR Part 11 dual electronic signatures with append-only audit trails.
Every decision has provenance.
Write Better Protocols. Make Them Computable.
Zen Protocol AI transforms protocol development from a document workflow into a structured clinical intelligence workflow.
ICH M11
Author protocols against the international M11 standard.
Legacy Conversion
Convert existing PDF and DOCX protocols into structured content.
Criteria Compiler
Transform eligibility criteria into deterministic, computable patient rules.
Protocol Intelligence
Structure study logic for downstream analysis and execution.
From document → structured protocol → computable trial.
Don't Guess Enrollment. Simulate It.
The Predictive Feasibility Engine models how your trial could actually enroll.
Monte Carlo simulation models:
Then calculates:
Probability of Success
How likely is the enrollment plan to hit its target?
P10 / P50 / P90
Your optimistic, median, and conservative completion timelines.
Sensitivity Analysis
Which assumptions are actually driving your timeline?
No guesswork. Just statistical simulation.
Explore Predictive Feasibility