PV Signal

Comprehensive, Compliant and User-Friendly Signal Detection and Management Solution

PV Signal is the industry’s most complete signal detection and management solution. It is fully compliant with EU GPV Module IX regulations. It provides a dynamic data mining environment for detecting signals, uncovering patterns, and recognizing emerging trends in spontaneous adverse event report data. PV Signal supports seamless review across various data sources and provides advanced signal analysis using machine learning and AI based technologies.

Save Operational time by leveraging PV Signal and instead use your time to focus on patient safety, long-term sustainability, and public health.

Key Features

  • Qualitative Signal Detection Ability to configure qualitative signal detection criteria using flexible user interface for proactive monitoring.
  • Quantitative Signal Detection Ability to perform quantitative signal detection on aggregate data using signaling algorithms.
  • Integrated Review Across Data Sources Ability to perform review of aggregate data across different data sources from single user interface with an ability to compare data across sources
  • Literature Review Integrated literature review using real-time search on most of the literature sources like PubMed and Embase
  • Signal Management User-friendly yet powerful out of the box workflow engine for signal management all the way from detection to action & communication. Compliant with GPV Module IX – Signal Management Regulations.
  • Internal and External Data Sources Ability to perform signal detection on internal and external data sources (FAERS, VAERS, EVDAS, VigiBase, JADER, Clinical Trials and Literature).
  • Advanced Trend Detection Advanced trend detection using machine learning and historical data.
  • Integrated Reporting and Analytics PV Signal is integrated with PV Reports module and Spotfire for integrated reporting and advanced data analysis.
  • Metrics and Dashboards Out of the box dashboards for Signal monitoring and summaries.

Key Benefits

  • Signal Detection – Provides ease of use in the configuration of signal detection rules-based alerts for qualitative and quantitative review.
  • Single Case Signal Detection and Management – Provides ease of use in the configuration of signal detection rules based on DMEs, Events of Interest, SUSARs and user-defined conditions. Provides ability to view case data in ICSR and Temporal views for assessment for detected signals.
  • Auto Triaging – Save time and cost by auto triaging the cases and drug-events pair, using built-in rule-based engine.
  • Single User Interface- A one stop application for integrated review for Qualitative, Quantitative, EVDAS, Literature and management of identified signals.
  • Efficient Review of EVDAS Data- Auto download, auto upload, triaging of eRMRs and case listings from EMA and adjudication of eRMRs.
  • Signal Management and Communication – Signal management and role-based to-do lists to process the detected signals.
  • Multiple Data Sources – Point in time capabilities and support for Argus, ARISg and other public databases.
  • Easy Scientific Analysis – Provides ability to perform OLAP with Analytical tools for case series that triggers signal detection.
  • User-Friendly Interface – Intuitive, simple to operate the system with almost no training required.
  • GxP and 21 CFR Part 11 Compliance – Provides full compliance with GxP and 21 CFR Part 11 requirements.