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CTWiseAPI

CTWiseAPI

Clinical Trial Regulatory Rules API

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CTWise Regulatory Rules API delivers instant, programmatic access to FDA CFR Title 21, ICH Guidelines (E6 GCP, E8, E9), EMA regulations, and WHO guidance. Unlike document-based solutions, query specific rule citations in milliseconds via REST API. 500+ regulatory rules covering 21 CFR Part 11, GCP compliance, informed consent, and IRB oversight with semantic search and version tracking. Ideal for pharmaceutical R&D, CROs, and clinical operations teams building compliant protocols.
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Launch tags:Productivity•Amazon•API
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Nitin Bhatti
Maker
📌
I'm Nitin, founder of OrchestraPrime. I built CTWise for a specific problem in clinical trials. **The Problem:** When pharma companies and CROs develop clinical trial protocols, they need to ensure compliance with FDA regulations, ICH guidelines, and other regulatory requirements. Today, this means: - Manually searching PDF documents - Paying consultants $500/hour for regulatory expertise - Using enterprise platforms with "contact sales" pricing **What We Built:** CTWise is a regulatory rules API that: - Provides 500+ specific rule citations (FDA CFR, ICH E6 GCP, E8, E9, EMA) - Uses semantic search (ask "informed consent requirements" not exact keywords) - Returns results in under 200ms - Costs $99/month (not enterprise pricing) **Who It's For:** - Clinical trial software building compliance features - CROs validating protocols - Biotech teams in regulatory affairs **Free Trial:** 14 days, 1,000 API calls on AWS Marketplace. Would love feedback from anyone in life sciences or clinical trials!
Nitin Bhatti
Maker

@david_firouzbakht Thanks for the upvote! Would love to hear more about what excited you about this product. Thank you.