SpeciGen provides an end‑to‑end biospecimen operations platform for clinical trials, combining the Hub module for full‑lifecycle sample tracking, automated data reconciliation, and 21 CFR Part 11 compliant audit trails with the Lens module for AI‑driven analytics
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trials generate large volumes of biospecimens that must be tracked, processed, stored, and linked to electronic data capture (EDC) systems while meeting strict regulatory requirements. Manual handling of sample data leads to mismatches, audit‑trail gaps, and delays in generating study reports.
Solution
SpeciGen offers an end‑to‑end biospecimen operations platform that centralizes tracking of collection, processing, storage, shipment, and disposal. The Hub module automatically reconciles lab samples with EDC records, provides 21 CFR Part 11 compliant audit trails, e‑signatures, and consent tracking, and generates FDA‑ready eTMF documents. The Lens module ingests assay results, maps them to samples, and delivers AI‑driven analytics, natural‑language queries, and real‑time dashboards with granular access controls for unblinded data. Integrated security features—including HIPAA compliance, SSO, and encryption—ensure data protection across multi‑vendor environments.
Target Audience
Primary customers are clinical trial sponsors, CROs, and central laboratories that need comprehensive biospecimen management and regulatory compliance across multi‑site studies.
Features
- Full‑lifecycle specimen tracker covering collection, processing, storage, shipment, and destruction
- Automated data reconciliation that auto‑matches lab samples to EDC records with manual override and anomaly detection
- 21 CFR Part 11 compliance with e‑signatures, consent management, audit logs, and study closeout capabilities
- Built‑in integrations with major EDC systems (Medidata Rave, Veeva, REDCap) and analytics tools (Tableau, Spotfire)
- Automatic generation of clinical study reports and FDA‑ready eTMF documentation
- Smart annotation engine that extracts and maps data from pathology and lab report PDFs
- Results Tracker for linking bioanalytical outcomes to samples with fine‑grained access controls for unblinded data
- AI‑powered insights offering natural‑language queries, real‑time dashboards, and intelligent study metrics