BlackCat Bio provides an AI-powered regulatory intelligence platform for clinical-trial biostatistics, helping sponsors prepare submission-ready statistical documents. The platform indexes over 500,000 FDA guidance documents, CRLs, and statistical reviews to ground statistical analysis plans, protocol reviews, and power calculations in regulatory precedent. It combines source-traced AI outputs with expert human review to deliver SAPs in as little as seven days.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical-trial sponsors face significant regulatory risk when their statistical approaches—protocol endpoints, SAPs, and power calculations—deviate from FDA precedent. Misaligned endpoints or underpowered analyses can trigger Complete Response Letters or fail only after data lock, costing sponsors a year or more in review cycles. Biostatistics teams lack efficient access to the FDA's historical guidance and reviews needed to ground their designs in documented precedent.
Solution
BlackCat Bio provides a regulatory intelligence platform that combines evidence-grounded AI systems with expert human review to streamline biostatistical document preparation for clinical trials. The platform searches over 500,000 indexed FDA guidance documents, Complete Response Letters, and statistical reviews to surface exactly which precedent supports or challenges a sponsor's planned approach, with every claim source-linked to the original document. It also pulls publicly available SAPs from studies matched by indication, phase, and design as baseline structuresable to adapt. Power calculations are grounded in actual effect sizes and variability from comparable trials rather than assumptions. The system handles protocol review, SAP optimization, and deliverable generation through a collaborative AI-and-expert workflow, with all outputs source-traced for auditability.
Target Audience
Primary customers are sponsors, CROs, and biostatistics teams running clinical trials—particularly those in Phase I, Phase III, or rare-disease programs—who need faster, more consistent document QA and SAP generation aligned with FDA regulatory expectations.
Features
- Search engine covering 500,000+ indexed FDA guidance documents, CRLs, and statistical reviews with source-linked results in seconds
- SAP templates derived from real studies matched to indication, phase, and design, not generic placeholders
- Power/sample-size calculations based on documented effect sizes and variability from comparable trials
- AI-assisted protocol review that stress-tests endpoints and design choices against FDA guidance and precedent, flagging gaps before agency submission
- SAP review and optimization that reassesses sample size, power, and analytic strategy against regulatory precedent to prevent underpowered trials
- Source-traced outputs with every claim linked back to the original regulatory document
- Combination of AI systems with human expert review from regulatory biostatistics specialists