Introduction to CTWiseAPI
CTWiseAPI is a regulatory intelligence API that helps clinical trial professionals quickly search and understand compliance requirements across multiple regulatory sources.
Watch the Demo
What is CTWiseAPI?
CTWiseAPI provides programmatic access to:
- FDA Guidance Documents - Current FDA guidance and regulations
- ICH Guidelines - International Council for Harmonisation standards
- EMA Regulations - European Medicines Agency requirements
- WHO Standards - World Health Organization guidelines
Key Features
🔍 AI-Powered Semantic Search
Ask questions in plain English like "What are the requirements for informed consent in pediatric trials?" and get semantically relevant FDA and ICH guidelines - not just keyword matches. Powered by Amazon Bedrock Titan embeddings with sub-second response times.
Learn more about Semantic Search →
📊 Evidence Chains
Trace regulatory requirements back to their source documents with confidence scores.
🔗 Cross-Reference Detection
Automatically identify related requirements across regulatory bodies.
⚡ Real-Time Updates
Stay current with the latest regulatory changes and updates.
483 Inspection Intelligence
Turn FDA inspection data into actionable compliance intelligence:
| Capability | API Endpoint | Value |
|---|---|---|
| Semantic Search | POST /v1/483/observations/search | Natural language search across all 483 observations |
| Facility Profiles | GET /v1/483/facilities/{fei_number} | Facility inspection history and classification breakdown |
| Risk Scores | GET /v1/483/risk-scores/{fei_number} | Composite risk score (0-100) with 5-factor breakdown |
| CFR References | GET /v1/483/cfr-references | Browse cited CFR sections with occurrence counts |
| Industry Benchmarks | GET /v1/483/analytics/benchmarks | Compare facility performance against peers |
Explore the Interactive Overview → | 483 Quickstart Guide →
Use Cases
| Use Case | Description |
|---|---|
| Protocol Development | Quickly identify regulatory requirements for clinical trial protocols |
| Compliance Auditing | Verify regulatory adherence with evidence-based citations |
| Training & Education | Build regulatory training materials with authoritative sources |
| Document Review | Automate regulatory review of clinical documents |
| Supplier Monitoring | Track supplier FDA inspection history and risk scores |
| Pre-Inspection Prep | Analyze trending citations and investigator focus areas |
Getting Started
Ready to start building? Follow our quickstart guide:
# Example: Your first API call
curl -X POST https://api.ctwise.ai/v1/search \
-H "X-Api-Key: YOUR_API_KEY" \
-H "Content-Type: application/json" \
-d '{"query": "informed consent requirements phase 1"}'
Pricing Tiers
| Tier | Price | API Calls/Month | Best For |
|---|---|---|---|
| Free | $0 | 1,000 | Evaluation |
| Starter | $99/mo | 10,000 | Small teams |
CTWiseAPI is available on AWS Marketplace for easy billing integration with your AWS account.
Support
- 📧 Email: support@ctwise.ai
- 📚 Documentation: You're here!
- 💬 Status: status.ctwise.ai