Panoptive adds an AI‑driven intelligence layer to clinical trial oversight tools, automatically extracting findings from monitoring reports and EDC data and converting them into structured, audit‑ready decision records with linked regulatory citations. The platform continuously updates a searchable trail, flags cross‑site safety or quality patterns in real time, and integrates with Veeva, Medidata, Oracle and other systems to reduce manual consolidation and streamline inspection preparation.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trial oversight data is scattered across monitoring reports, EDC systems, trackers, and email threads, making it difficult to detect safety and quality issues early. Findings often remain buried in multi‑page documents, and audit trails must be reconstructed under pressure during inspections, exposing gaps and delays.
Solution
Panoptive adds an intelligence layer to existing clinical trial systems, automatically extracting safety and quality findings from unstructured reports and EDC data. It structures sponsor decisions by linking them to evidence, protocol sections, ICH‑GCP clauses, and SOPs, creating a continuous, inspection‑ready audit trail. The platform flags cross‑site patterns early, enabling proactive issue resolution and reducing the time spent on CTM/QA review. Generated rationale and citations are reviewable and approvable by users, ensuring regulatory‑compliant documentation without replacing existing tools.
Target Audience
Primary customers are clinical trial sponsors, CROs, and internal clinical operations or quality teams that need to maintain defensible oversight records and streamline audit preparation.
Features
- AI‑driven extraction of findings from monitoring reports, EDC outputs, trackers, and email threads
- Automatic drafting of inspection‑ready rationale with hyperlinked citations to protocols, ICH‑GCP clauses, and SOPs
- Structured decision capture that ties each decision to supporting evidence and rationale
- Continuous audit‑readiness record that updates in real time as new findings and decisions are logged
- Cross‑site pattern detection to surface systemic issues early in the study lifecycle
- Seamless integration with existing systems such as Veeva, Medidata, Oracle, and custom setups
- SOC 2 Type II, 21 CFR Part 11, and HIPAA‑aligned security with encryption at rest and in transit