OmniScience Vivo is an AI-driven control tower designed to revolutionize clinical trial operations by unifying fragmented data sources and providing real-time, actionable insights. By integrating data from electronic data capture (EDC) systems, clinical trial management systems (CTMS), laboratories, safety databases, and more, Vivo enables clinical teams to monitor trial progress, identify risks, and make informed decisions swiftly.
Key Features and Functionality:
- Unified Trial Data: Aggregates clinical, operational, safety, and specialty data into a single, governed platform, ensuring full source traceability.
- Ask Vivo: Allows users to pose plain-language questions about live trial data and receive evidence-backed answers grounded in protocol context.
- Trial Home: Provides a continuously updated dashboard displaying trial status, recent changes, and pending actions.
- Continuous Monitoring: Employs AI-driven risk-based quality management (RBQM) to detect missing, late, inconsistent, or high-risk patterns, converting signals into actionable alerts.
- Portfolio Intelligence: Offers cross-study visibility into risks, site performance, vendor management, enrollment metrics, and data quality across an entire portfolio.
- Governed & Validated: Complies with GDPR, GxP, Part 11/Annex 11, ISO 27001, and ISO 9001 standards, featuring role-based access control, blinding awareness, and comprehensive audit trails.
Primary Value and Problem Solved:
Vivo addresses the challenge of managing dispersed and complex clinical trial data by centralizing information and delivering real-time insights. This integration reduces manual reporting, accelerates decision-making, and enhances patient safety. By providing a unified view of trial operations, Vivo empowers clinical development teams to proactively identify and mitigate risks, ultimately improving trial outcomes and expediting the delivery of life-changing treatments to patients.
