TriNetX EVIDEX is a cloud-based, software-as-a-service (SaaS) platform purpose-built for pharmacovigilance (PV) teams in life science organizations. It provides a unified, panoramic view of drug safety data by combining the TriNetX global network of de-identified Real-World Data (RWD)—over 250 million patient records—with public safety data sources like FAERS, VigiBase, EVDAS, ICSR, Health Canada, ClinicalTrials.gov, and VAERS.
EVIDEX is designed to replace legacy systems, offering an intuitive user interface that eliminates the need for users to be data scientists to gain insights. The platform streamlines workflows, ensures audit readiness, and helps maintain regulatory compliance, including being fully validated off-the-shelf based on GVP Module IX–Signal Management guidelines. Key capabilities span the entire signal management lifecycle: detection, assessment, validation, prioritization, and reporting.
Key Features & Capabilities:
- Multi-Source Signal Detection: Run multi-modal signal detection from harmonized RWD and public safety databases in a single system.
- Automated Workflows: Find and validate new potential signals within RWD and set automated review workflows.
- Advanced Analytics: Use multi-source comparisons, trend analysis, and disproportionality calculations (ROR, PRR, EGBM) in seconds.
- Signal Management: Track and resolve safety signals from any data source with audit-ready tools, customizable filters, and detailed user-level tracking.
- Real-World Data Integration: Immediate access to over 250 million de-identified global patient records for signal refinement and characterization.
- GVP Module IX Compliance: Off-the-shelf validation and audit trail creation to fulfill regulatory duties.
The platform is flexible and scalable, serving organizations with both high and low volumes of signals, and is supported by a dedicated Product Specialist Team offering ongoing training and Hypercare Support during implementation.