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Monitoring of adverse events is essential to identifying trends that may indicate emerging safety issues in medicines and vaccines.
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VigiLyze is a signal detection and signal management tool that uses insights into the safer use of medicines from members of the WHO Programme for International Drug Monitoring (WHO PIDM) as a starting point for efficient quantitative signal detection. It supports national signal management processes, including qualitative assessments.
VigiLyze provides a global context for your national data through its close integration with VigiBase, WHO’s global database of reported potential side effects of medicinal products. This huge collection of data supports assessments of emerging domestic issues. Through VigiLyze you have easy access to post-marketing safety information for medicinal products that are new to your national market but marketed in other parts of the world.
VigiLyze is provided free of charge to national centres in all member countries of the WHO PIDM. Major strengths include the ability to recalculate disproportionality based on any chosen country or group of countries within seconds and ready access to related investigations, shared nationally or globally, when searching for the same (or similar) medicinal products and reactions.
By sharing their data and knowledge with the global database, member countries help increase each other’s understanding of potential safety concerns and reduce the risk of harm from medicines.
We were almost done with identifying our first signal, but we lacked the confidence to flag it. We requested UMC provide us with technical support, a decision that turned out to be a landmark along our journey to success. We are now among the countries sharing their signals through VigiLyze.
Mulugeta Russom Pharmacoepidemiologist and Pharmacovigilance Specialist Head, Eritrean Pharmacovigilance Centre
VigiLyze supports the entire signal detection and management process, giving you the ability to assign investigations to your team and document your work within the system. It is easy to connect an assessment to medicinal product and reaction and it will show up as a related investigation when searching for the same (or similar) medicinal products and reactions in the future. This minimises the risk of doing the same assessment again when an issue emerges. You can even upload documents, such as signal checklists, templates or supporting references to your investigation. After finalising a signal assessment, you can easily share it with the WHO PIDM community in VigiLyze where it will then show up as a related investigation when they search for similar medicinal products and reactions.
VigiLyze instantly provides overview graphs, case line listings and disproportionality calculations for national data, but the global view is either side-by-side or only a click away.
Disproportionality calculations are based on the country or group of countries selected by the user (the default is “my country”). This background can easily be changed and does not require time-consuming data mining runs; it will recalculate in seconds depending on the user’s choice.
VigiLyze allows for a streamlined signal detection process and makes our internal process far more efficient. Analysis is performed without delay in a user-friendly and impressively intuitive interface where it is easy to keep track of filters and data sets.
Gunnar Rimul Senior pharmacovigilance adviser at the Norwegian Medicines Agency (NoMA)