Geninvo provides an AI‑driven platform that automates data integration, study design, and regulatory document quality control for clinical trials. Its plug‑and‑play modules integrate with existing LIMS, EDC and data warehouses, delivering real‑time data cleaning, mapping and compliance monitoring while adhering to ISO‑27001 security standards.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trial teams often struggle with fragmented data workflows, manual document handling, and compliance burdens, leading to slow study design, execution delays, and increased risk of regulatory non‑conformance.
Solution
Geninvo offers an AI‑driven platform that automates data integration, study design, and document quality control across the clinical trial lifecycle. The solution leverages generative AI to review and standardize regulatory documents, while machine‑learning models streamline data cleaning, mapping, and monitoring. Built as modular, plug‑and‑play components, the platform can be layered onto existing life‑science IT stacks without extensive re‑engineering. Security and compliance are embedded through ISO‑27001‑aligned information security controls, ensuring data protection and audit readiness. The platform’s scalable architecture supports enterprise‑level deployments, enabling faster trial setup, real‑time analytics, and consistent regulatory adherence.
Target Audience
Primary customers are pharmaceutical companies, contract research organizations, and biotech firms that manage large‑scale clinical studies and require automated, compliant data solutions.
Features
- AI‑powered document quality control that automatically detects inconsistencies, missing fields, and compliance gaps
- Generative AI tools for rapid drafting and standardization of clinical trial protocols, CRFs, and regulatory submissions
- Scalable, plug‑and‑play modules that integrate with existing LIMS, EDC, and data warehouses via APIs
- End‑to‑end data automation pipelines for cleaning, mapping, and monitoring trial data in real time
- ISO‑27001‑aligned information security management system (ISMS) protecting all data assets and supporting audit trails
- Customizable workflows and licensing options to match diverse organizational processes and compliance requirements