Design protocols.
Make them computable.
Zen Protocol AI is a clinical trial protocol design software built for modern clinical development.
Author to ICH M11. Convert legacy protocols. Compile eligibility criteria into computable rules. Simulate enrollment before you commit.
One protocol workspace. From design to feasibility.
For Sponsors · CROs · Clinical Development Teams
Protocols are still built like documents.
Word files. PDFs. Manual revisions.
Eligibility criteria buried in prose.
Feasibility estimates built on assumptions.
The protocol is the blueprint for the trial.
It should be structured like one.
A new workspace for clinical trial protocol design.
Zen Protocol AI brings protocol authoring, structured study logic, eligibility compilation, and feasibility into one workflow.
ICH M11
Author clinical trial protocols against the international ICH M11 standard.
Structured Authoring
Build protocols as structured clinical content—not just pages of text.
Legacy Conversion
Transform existing PDF and DOCX protocols into structured, editable content.
Criteria Compiler
Convert inclusion and exclusion criteria into deterministic, computable patient eligibility rules.
Protocol Intelligence
Connect protocol sections, study logic, endpoints, populations, and eligibility criteria.
From document → structured protocol → computable trial.
Design with structure from day one.
Good protocol design is more than writing. It is about making every decision clear, consistent, and operational.
Define
Structure the study population, objectives, endpoints, interventions, and design.
Standardize
Build against the ICH M11 protocol standard.
Validate
Identify inconsistencies across protocol logic and dependent content.
Compile
Turn eligibility language into deterministic rules.
Simulate
Test feasibility before the protocol becomes a commitment.
Your existing protocols. A structured starting point.
Have years of protocols sitting in Word and PDF? Bring them into Protocol AI.
Preserve the clinical content while transforming legacy documents into a structured authoring environment.
No need to start from scratch.
Turn clinical language into computable rules.
Eligibility criteria are often written for humans. Clinical systems need something more precise. Protocol AI's deterministic criteria compiler transforms protocol eligibility language into structured, computable rules.
Inclusion
Translate patient inclusion requirements into structured logic.
Exclusion
Define exclusion conditions as explicit rules.
Computability
Create criteria that can be interpreted consistently by downstream systems.
Traceability
Maintain a clear connection between the original protocol language and the compiled rule.
Human-readable → machine-computable.
Built around the global protocol standard.
Protocol AI is harmonized to the ICH M11 standard for clinical trial protocol authoring. Create protocols with standardized structure while maintaining the flexibility required for real-world clinical development.
- Standardized structure.
- Structured content.
- Better downstream interoperability.
Author once. Structure for what comes next.
Don't design in the dark.
Protocol design and trial feasibility are connected. A change in population, eligibility, geography, site assumptions, or dropout can change the enrollment curve. Protocol AI brings feasibility intelligence into the protocol workflow.
Monte Carlo Simulation
Model thousands of possible enrollment scenarios instead of relying on a single estimate.
Probability of Success
Calculate the probability that your enrollment plan reaches its target.
P10 / P50 / P90
See optimistic, median, and conservative completion timelines.
Sensitivity Analysis
Identify the assumptions that have the greatest impact on trial completion.
Design the protocol. Simulate the trial. Understand the risk.
From protocol idea to trial intelligence.
Design
Build the protocol in a structured workspace.
Standardize
Align content to ICH M11.
Structure
Convert legacy documents and organize study logic.
Compile
Transform eligibility criteria into computable rules.
Simulate
Model enrollment and completion scenarios.
Decide
Move forward with evidence—not assumptions.
One workspace. A smarter protocol lifecycle.
Structured by design
Protocols become structured clinical data—not static documents.
Computable by default
Eligibility criteria can move from prose to deterministic logic.
Feasibility-aware
Understand enrollment risk while the protocol is still being designed.
Built for standards
Harmonized to ICH M11.
Ready for what comes next
Create protocol content that can support downstream clinical systems and workflows.
AI drafts. Rules decide.
Protocol AI uses AI where it adds speed and deterministic logic where precision matters.
AI
Drafts · Converts · Assists · Explains
Deterministic Engines
Compiles · Validates · Structures
Statistical Simulation
Models · Forecasts · Quantifies
Clinical Teams
Review · Refine · Decide
Intelligence without black-box decisions.
Teams designing the next generation of trials.
Sponsors
Design and refine protocols faster.
CROs
Standardize protocol development across studies and sponsors.
Clinical Development Teams
Connect protocol design with feasibility intelligence.
Clinical Research Teams
Move from document-centric workflows to structured clinical intelligence.
Your protocol is more than a document.
Build it that way.
Design structured, computable, feasibility-aware clinical trial protocols with Zen Protocol AI.
Clinical Trial Protocol Software
Built for modern clinical development.