Counterpoint offers a governed knowledge‑graph platform that transforms SOPs, protocols, and regulatory frameworks into an automated compliance system for CROs, CDMOs, and biotech sponsors. The platform continuously updates documentation, training, and role‑based authorizations as products and requirements change, providing on‑demand inspection‑ready evidence and reducing operational friction while maintaining strict regulatory oversight.
Funding
Funding not disclosed
Founders
Product
Problem
Regulated life‑science organizations must constantly update SOPs, protocols, and compliance documentation as products, procedures, and regulatory requirements change, leading to high manual effort, fragmented records, and risk of non‑compliance during inspections.
Solution
Counterpoint offers a governed platform that ingests SOPs, protocols, and regulatory frameworks and converts them into a structured knowledge graph. The graph enforces governance logic, automatically scopes outputs to the appropriate roles, and continuously updates content, training, and assessments when requirements evolve. Subject‑matter experts review and approve all generated outputs through a streamlined interface, ensuring no unvetted AI content enters the system of record. The platform maintains end‑to‑end operational lineage—from regulatory requirement to individual authorization—allowing on‑demand generation of complete inspection evidence. By providing a unified yet isolated governance layer across multiple sponsors, programs, and sites, Counterpoint reduces operational friction, lowers compliance costs, and supports scalable growth.
Target Audience
Primary customers are CROs, CDMOs, and biotech sponsors that manage regulated operations across multiple trials, sites, and manufacturing programs.
Features
- Knowledge‑graph engine that models SOPs, protocols, and regulatory rules to enforce role‑based governance
- Automated change‑impact analysis that generates updated content, training modules, and assessments for affected personnel
- Structured review workflow for subject‑matter experts and quality teams to approve AI‑generated outputs
- Continuous operational lineage tracking linking requirements to content, training, and individual authorizations
- On‑demand evidence package generation for inspections, audits, and regulatory reviews
- Multi‑sponsor isolation with a unified governance layer to manage overlapping personnel across concurrent programs