Clinevo Signal Detection

Automated signal detection and management for pharmacovigilance with quantitative algorithms, smart triaging, and regulatory compliance.

Overview

Clinevo Signal Detection is an end-to-end signal detection and management solution designed for pharmacovigilance teams in life sciences, pharmaceutical, biotech, and CRO organisations. It covers the full cycle of signal identification, assessment, tracking, and management, and is built to meet regulatory requirements across multiple global standards.

The platform supports both quantitative and qualitative signal detection on aggregate data, with the ability to perform detection across internal and external data sources including FAERS, EVDAS, VAERS, clinical trials, and literature. It integrates with a safety reporting module and provides dashboards for signal monitoring and summaries.

Core Signal Detection Capabilities

Flexible user interface for proactive signal monitoring
Quantitative signal detection on aggregate data using signaling algorithms
Provides statistical metrics including Case Counts, New Cases, PRR, ROR, EBGM, EB05, and CHISQ
Ability to compare data across sources and across quarters
Signal Topic Management functionality
Detection on both internal and external data sources (FAERS, EVDAS, VAERS, Clinical Trials, Literature)
Integration with safety reporting module
Dashboards for signal monitoring and summaries

Smart Detection and Analysis Features

Configurable Thresholds: Rule-based alerts can be set for both qualitative and quantitative signal detection reviews and monitoring
Auto Triaging and Topic Management: An in-built rule-based engine automatically triages cases and drug-event pairs to reduce manual effort and costs
Scientific Analysis: Case series analysis tools are available to support faster signal detection
Signal Detection and Management: Signals can be detected and managed based on DMEs, SUSARs, EOIs, and custom rules, with case review available through ICSR and Temporal views

User Experience

Single User Interface: Centralised platform for integrated review and management of identified safety signals
User Adoption: Designed to be intuitive and operable with minimal training
Signal Management Workflows: Role-based to-do lists and configurable workflows support end-to-end signal management processes
Web Access: Accessible via internet or intranet through IE, Chrome, and Firefox browsers

Integration and Data Sources

Connects with Clinevo Safety, Oracle Argus, ArisG, and other databases for data intake
Supports multiple external pharmacovigilance data sources including FAERS, EVDAS, and VAERS

Compliance and Regulatory Standards

Compliant with 21 CFR Part 11, ANNEX 11, GxP, and GDPR
Includes automated compliance checks and robust audit trails

Clinevo Signal Detection is a cloud-based, web application used by clients across the USA, UK, Europe, Korea, Japan, China, and India. The platform is supported by an implementation and training team, and is positioned to cover every stage of the signal management workflow from initial setup through to final reporting.