Pharmacovigilance

Ennov Software keep the management of human or veterinary adverse events in one fully-accessible database.

The most advanced signal detection and analysis tools to manage adverse events.

Compliance

Comprehensive Pharmacovigilance management tailored for your business.

Capture and manage data while maintaining complete regulatory compliance


Why it matters? Pharmacovigilance data management should be an efficient and accurate process. With the PV-Works Human or PV-Works Veterinary software your team will be able to focus their time on analyzing and understanding the data. Meanwhile you will have complete confidence that the critical aspect of regulatory compliance, including electronic reporting, will be met.

Chose the implementation mode that meets your business needs


Why it matters? The pharmacovigilance regulations remain the same regardless of the size of your company or the number of cases you are processing. Ennov offers everything from hosted pay-as-you-go solutions (see www.pv247.com) to global in-house installations – anything from 10 cases per year to over 100,000. Our highly regarded software is relied upon by all types of human and veterinary company including major regulatory authorities and CROs (to monitor pharmaceuticals, biologicals, and medical devices).

Analysis

Have a clear understanding of your product with powerful data analysis and signal detection.

Automate the detection of signals and trends


Why it matters? Implementing a process to identify potential signals is essential. With PV-Analyzer you can rapidly calculate key statistical measures such as PRR, ROR, and MGPS and apply smart stratification to examine the database and detect where customizable thresholds have been exceeded.

Get a real-time overview of your safety database with dynamic metrics and dashboards


Why it matters? Your pharmacovigilance database contains a wealth of important information about your products. The extensive mining and reporting capability of PV-Analyzer brings this knowledge to your fingertips allowing you to prepare detailed analyses and graphical outputs for both internal and external use. The application integrates easily with both PV-Works (Human or Veterinary) and other external data sources to increase flexibility in preparing such important metrics.

Mobility

Collect essential pharmacovigilance data from a wide range of sources using intuitively a structured capture interface and the reporter’s local language.

Extend the scope of your data entry


Why it matters? The quality and range of your incoming pharmacovigilance data is vital to the outcomes and decisions you reach. PV-Express allows more stakeholders to contribute to the data collection process. The information collected is more accurate and reliable using your own language and approved vocabularies.

Capture your case information on-the-go with PV-Express mobile app


Why it matters? Entering the same data twice is laborious and error prone. With PV-Express mobile application, users can capture any case information on their favorite device (i.e., PC, tablet or smartphone) and submit it directly and securely to the central database. No re-keying. No mistakes. Just fast, accurate cases.

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