EVIDEX

EVIDEX® is a pharmacovigilance platform developed by Advera Health Analytics, a wholly owned subsidiary of TriNetX, LLC. It is designed to help life sciences and drug safety organizations detect, analyze, and manage safety signals in a thorough, transparent, and compliant manner. By combining the EVIDEX® platform with the TriNetX global network of deidentified real-world data (RWD), users gain access to more than 250 million global patient records, enabling a panoramic view of real-world evidence that goes far beyond the capabilities of legacy pharmacovigilance systems.

Built to serve organizations with both high and low volumes of signals, EVIDEX® is flexible, scalable, and configurable to meet even the most complex signal detection and management requirements. It provides a unified, intuitive alternative to outdated legacy systems and manual processes, empowering drug safety teams to monitor more broadly, analyze more quickly, and report more accurately.

Core Platform Capabilities

• Signal Detection & Refinement: Reduces the burden of false positives by detecting and assessing the sufficiency, strength, and consistency of evidence, allowing teams to focus on the most relevant and significant signals.
• Signal Management: Enables compliant management, reporting, and sharing of safety information both internally and externally, with transparency, clarity, and accuracy.
• Seamless Workflow Integration: Provides a unified system for managing signal detection and signal management workflows, replacing fragmented legacy tools and manual processes.
• Global Real-World Data Access: Leverages the TriNetX network to provide access to more than 250 million deidentified global patient records for comprehensive pharmacovigilance analysis.

GVP Module IX Signal Management Compliance

• Signal Detection: Supports review of data from spontaneous reporting sources including FDA Adverse Event Reporting System (FAERS), EudraVigilance, and VigiBase, as well as active surveillance, studies, and scientific literature. Facilitates manual review of Individual Case Safety Reports (ICSRs), statistical analyses, and disproportionality analysis in line with GVP IX Addendum I guidance.
• Signal Validation: Assists in confirming new potentially causal associations or new aspects of known drug-event associations by providing access to robust ICSR data, both at the individual case and aggregate level. Supports evaluation of previous awareness, strength of evidence, and clinical relevance and context.
• Signal Prioritization & Assessment: Supports the determination of whether validated signals suggest risks with important impact on patients or public health, and helps dictate the timeframe for completing signal management activities. Enables simultaneous signal assessment by allowing safety reviewers to consider all available evidence for or against a causal association.
• Quality & Auditability: Ensures that all stages of the signal management process are adequately documented, tracked, and auditable, providing full transparency into the who, what, why, and when of each step taken.

Advantages Over Legacy Systems

• Best-in-class user interface designed to eliminate the intimidating user experience common in legacy platforms.
• Fast, validated implementation process, reducing the long and costly deployment timelines associated with older systems.
• Advanced data-and-analytics-first approach, replacing outdated analytic tools with modern, integrated capabilities.
• Eliminates the need for band-aid approaches to data and analytics-focused workflows.

Research and Educational Resources

• Access to a pharmacovigilance (PV) library of publications and research resources.
• Comprehensive guides, including an 18-page complete guide to GVP Module IX for Signal Management, covering signal detection, validation, prioritization, assessment, and quality requirements.

EVIDEX® is part of the broader TriNetX ecosystem, which spans clinical trial design and optimization, datasets and analytics, real-world evidence generation, and non-US oncology research. As a registered trademark of Advera Health Analytics, Inc., EVIDEX® is positioned as a next-generation solution for drug safety departments seeking to move beyond the status quo of legacy pharmacovigilance software.