VigiLyze

VigiLyze is a signal management application developed by UMC (Uppsala Monitoring Centre) that builds on the case assessment capabilities of VigiFlow. It is designed for national pharmacovigilance centres and WHO Programme for International Drug Monitoring (PIDM) members who need to validate and contextualise their national safety data against global and regional data held in VigiBase.

VigiBase, which underpins VigiLyze, is the world's largest source of post-marketing safety data, containing millions of adverse event reports for medicines and vaccines from more than 180 member organisations. Reports are coded using standardised terminologies including MedDRA and UMC's Drug Dictionary, WHODrug Global, enabling systematic data mining, structured data retrieval, and precise analysis.

Signal Detection

• Provides disproportionality analysis and hypothesis generation using global data from VigiBase.
• Incorporates WHODrug and MedDRA to allow filtering and analysis by specific medicines, vaccines, or adverse events.
• Countries with large data sets can use purpose-built algorithms to uncover hidden patterns and potential safety signals that might otherwise be missed.
• Countries with smaller data sets can access global or regional data to identify signals that may not be apparent from their national data alone.

Signal Management

• Supports the full signal management process, from detection through assessment and communication.
• Allows users to search VigiBase for insights into medicines and vaccines that are new to their market but already in use elsewhere.
• Enables documentation and tracking of completed and ongoing investigations to help prioritise work.
• Supports efficient management of large, complex data sets to surface potential safety signals.

Collaborative Signal Work

• Users can view signals identified by UMC and shared by other WHO PIDM members, providing a starting point for investigations or a means of validating existing signal work.
• Sharing safety signals within VigiLyze creates opportunities for cross-border collaboration and improves medicines and vaccine safety globally.
• UMC's Signal Management team works closely with WHO to strengthen signal detection capacity among programme members.

Key Features

• Instant access to VigiBase for analysing national data alongside regional and global data.
• Dashboards and advanced statistical methods to support data analysis.
• Custom Search service for complex inquiries requiring specialised methods, available on request and free of charge.
• Tools to manage and document signal work, supporting cooperation and information sharing at the national level.
• Access to signals identified by UMC or shared by other WHO PIDM members for further investigation and potential collaboration.

Data Security and Access

• Data access is governed by Data Access Conditions that prioritise information security and transparency in data sharing.
• VigiLyze is part of the broader Vigiverse suite of tools and integrates with VigiFlow and VigiBase.

VigiLyze is available to registered users who share their national data with VigiBase. Related resources include VigiLyze product documentation, VigiBase data access information, and FAQ pages for both Vigiverse and VigiBase. Enquiries can be directed to UMC via [email protected].