How It Works

From concept to compliant protocol

Our AI handles end-to-end protocol automation while your team focuses on clinical strategy. Four simple steps to FDA-ready protocols.

1
5-10 min
Input Phase
Enter study parameters into Panaceon's intuitive form
2
Instant
AI Intelligence
AI generates comprehensive protocol with compliance scoring
3
1-2 hours
Expert Review
Medical writers review, add nuance, and refine content
4
Continuous
Lifecycle
Track amendments, versions, and maintain compliance
1

Input Phase

Medical writer enters core study parameters into Panaceon's intuitive form. Simple inputs, comprehensive outputs.

→Study objectives and therapeutic indication
→Phase (I/II/III), target population, and sample size
→Primary and secondary endpoints
→Key safety considerations
→Regulatory agency (FDA, EMA, or both)
Therapeutic Area
Oncology
Trial Phase
Phase III
Study Design
Randomized, Double-Blind
Sample Size
450 participants
Primary Endpoint
Overall survival at 24 months
2

AI Intelligence

Our AI instantly generates a comprehensive, regulatory-grade protocol. Intelligent analysis, compliance scoring, and strategic alternatives, all automated.

→Generates regulatory boilerplate (background, rationale, methods)
→Creates inclusion/exclusion criteria templates
→Pulls relevant FDA/EMA guidance documents
→Auto-populates compliance checklists
→Flags sections that commonly trigger FDA RTFs
🧠
✓Analyzing 500K+ similar trials...
✓Cross-referencing FDA guidance...
Generating protocol sections...
○Running compliance validation...
3

Expert Review & Refinement

Medical writers review the AI-generated content, add clinical nuance, and ensure scientific rigor. The human expert validates, refines, and perfects.

→Review all AI-generated sections for accuracy
→Add indication-specific clinical considerations
→Refine endpoints and adjust inclusion/exclusion criteria
→Ensure alignment with trial strategy
→Make final scientific and strategic decisions
Section 3.1 — Study Objectives
💡 AI Suggestion
94%
Compliance
Critical0
Warnings2
Info5
4

Lifecycle Management

Our AI continuously monitors and manages your protocol's entire lifecycle. From compliance checking to intelligent amendment tracking, complete automation from start to finish.

→Real-time compliance checking as you edit
→Amendment tracking with ripple-effect detection
→Cross-referencing automation across all sections
→Regulatory intelligence alerts (new FDA guidances)
→Version control with complete audit trail
🔄
Version Control
⚡
Amendments
🔔
Alerts
Version 3.2
Amendment #2 · Today
Current
Version 3.1
Minor edits · 2 days ago
Platform Features

Everything you need to build better protocols

A comprehensive suite of AI-powered tools designed for clinical trial protocol development

⚡

AI Protocol Generation

Generate complete protocol sections from simple prompts. Our models are trained on 500K+ clinical trials across all therapeutic areas.

"Generate eligibility criteria for Phase II NSCLC trial with EGFR mutation..."
✓

Real-time Compliance

Validate against FDA, EMA, and ICH guidelines as you write.

FDA
94%
EMA
91%
ICH
97%
🔔

Regulatory Intelligence

Stay ahead of regulatory changes with automatic guidance tracking and protocol impact analysis.

⚠️
Active Alerts
⚠
New FDA Guidance Published
CAR-T Cell Therapy: Updated safety monitoring requirements may affect 2 active protocols
⚡ 2 protocols affected
NEWEMA Oncology Guidelines 2025
UPDATEDICH E6(R3) GCP Addendum
🔍

Knowledge Base

Semantic search across 3M+ regulatory documents and trials.

🔍CAR-T dosing schedules...
FDACAR-T Cell Therapy Guidance 2024
TrialNCT04821674 - KYMRIAH Protocol
🔄

Amendment Tracking

Predict downstream effects before making changes.

From
v2.1
→
To
v2.2
Ripple Effects4 sections affected
👥

Team Collaboration

Work together in real-time with comments, suggestions, and approval workflows. Everyone stays aligned on the latest version.

SM
JK
AR
+3
Dr. Jessica Kim
The inclusion criteria looks good. Can we add ECOG PS requirement?
📊

Analytics Dashboard

Track protocol metrics and team productivity.

12
Protocols
89%
Avg Score
500K+
Protocols Analyzed
200+
Regulatory Documents
40%
Faster Development
97%
Compliance Accuracy

Ready to Transform Your Protocol Workflow?

Start your 14-day free trial today. Full Professional features. No credit card required.

Start 14-Day Free Trial