Hill Research provides a multi‑agent AI platform, TriClick™, that automates clinical trial data workflows—from protocol design and CRF/CDISC annotation to statistical programming and evidence synthesis. The system generates CDISC‑ready, audit‑trail enabled deliverables, accelerating TLF generation by up to 2,000× while ensuring compliance with HIPAA, 21 CFR Part 11, and GxP standards.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trial data management involves manual, time‑consuming processes for protocol design, data annotation, statistical programming, and regulatory submission, leading to high costs, long cycle times, and risk of non‑compliance with standards such as CDISC, 21 CFR Part 11, and GxP.
Solution
Hill Research offers a multi‑agent AI platform, TriClick™, that automates key stages of the clinical data workflow—from protocol design and CRF annotation to statistical programming and evidence synthesis. The system generates CDISC‑ready outputs with built‑in audit trails, ensuring reproducibility and regulatory readiness. By leveraging AI‑driven annotation and automated TLF generation, the platform accelerates statistical programming by up to 2,000× while maintaining traceability. Integrated validation, anonymization, and compliance checks reduce manual effort and lower the risk of inspection findings. The end‑to‑end solution supports faster study execution, cost reduction, and consistent adherence to industry standards.
Target Audience
Primary customers are pharmaceutical companies, biotech firms, and contract research organizations that conduct clinical trials and require efficient, compliant data management and biostatistics workflows.
Features
- TriClick™ Annotation: AI‑powered CRF and CDISC mapping with rapid, consistent annotation.
- TriClick™ Stats: Automatic generation of tables, listings, and figures (TLFs) directly from statistical analysis plans, ensuring accuracy and traceability.
- TriClick™ Compliance: Built‑in validation, anonymization, and audit‑trail generation for CDISC‑ready, inspection‑ready deliverables.
- TriClick™ Evidence: Extraction and synthesis of multi‑source evidence to support clinical and regulatory decision‑making.
- Multi‑agent AI architecture that orchestrates workflow steps, reducing manual hand‑offs and cycle times.
- Full compliance with HIPAA, CDISC, 21 CFR Part 11, and GxP requirements.