ENNOV Pharmacovigilance SUITE
Signal Detection and Management
Next Generation PV Software
- Detailed analyses and graphical output with key statistical measures
- Fully searchable repository of all signal management activity
- Dashboard provides signals in various stage of work-up “at a glance”
- Review data and evaluate signal evolution
- Highly configurable workflows that align with your risk management processes
- Integration with qualitative and quantitative review of adverse event data
The Signal Identification Challenge
Implementing a process to identify potential signals is essential. Ennov’s PV solution contains a comprehensive signal detection and data mining tool. The application, designed for use out-of-the-box by business users, offers a broad array of statistics as well as powerful data cubing and visualization functionality.
With the solution you can rapidly calculate key statistical measures that are widely used by regulatory authorities such as PRR, ROR, and MGPS and apply smart stratification to examine the database and detect where customizable thresholds have been exceeded. The application integrates easily with other PV solutions, and various external data sources to increase flexibility in preparing such important metrics.
Pharmacovigilance Signal Management Software
Take advantage of a fully searchable repository of all signal management activity, allowing users to review previous data and conclusions and evaluate the evolution of a given signal over time. It includes configurable workflows that are aligned with your risk management processes.
Upon completion of a signal workup, a “Signal Summary Report” is automatically generated, documenting when and how the signal was identified as well as the information collected throughout the signal evaluation and analysis process.
It can be integrated with other innovative Ennov products used for the qualitative and quantitative review of adverse event data. Signals derived from the robust set of built-in statistical analyses included with the solution are populated via our REST API and used to record signal information and its defined risk level.
Ennov’s Pharmacovigilance suite keeps the collection, management, assessment, and reporting of human or veterinary adverse events in one unified database while also providing advanced signal detection and PV data analysis tools.