BIONABU Information

Bionabu® is a Clinical Trial Integrity Platform built to eliminate operational risk, ensure regulatory compliance, and restore data quality to global clinical trials. Engineered explicitly for Contract Research Organisations (CROs) and pharmaceutical sponsors, our technology bridges the gap between active site data collection and absolute inspection-readiness. Rather than managing basic data storage like a legacy Electronic Data Capture (EDC) system, Bionabu operates as a proactive data-governance framework aligned with modern Risk-Based Quality Management (RBQM) principles. ⚙️ OUR CORE DEPLOYMENT: VERA DEVIATE™ Traditional clinical workflows treat protocol deviations as an administrative note to be logged and reviewed weeks after the event. Vera Deviate™ functions as active "Air Traffic Control" for your study, providing a real-time, traceable path from deviation detection to resolution. Unified Data Ingestion: Automatically aggregate data streams from site logs and EDC exports into one interface. Intelligent Mapping: Automatically detect data sources and map fields by subject. Role-Based Chain of Custody: Enforce mandatory reviewer validation loops (CRA ➔ PI ➔ Medical Monitor ➔ QA ➔ Sponsor). 🔐 ENTERPRISE-GRADE REGULATORY COMPLIANCE Bionabu is built from the ground up to support the absolute data integrity demands of high-stakes clinical research: Fully compliant with FDA 21 CFR Part 11 electronic signatures and unalterable system-generated audit trails. Formatted for modern ICH E6(R2) and E6(R3) Quality-by-Design directives. Cryptographic data isolation with enterprise-grade AES-256 encryption at rest and TLS 1.3 in transit. 🚀 ZERO-DISRUPTION INTEGRATION We offer structured, risk-free enterprise sandbox environments and rapid Proof of Concept (POC) onboarding. Learn more and request enterprise sandbox access at: bionabu.com