Quanticate upgrades pharmacovigilance database

By Melissa Fassbender contact

- Last updated on GMT

Quanticate is a global CRO focused on the management, analysis, and reporting of data from clinical trials and post-marketing surveillance. (Image: iStock/PRImageFactory)
Quanticate is a global CRO focused on the management, analysis, and reporting of data from clinical trials and post-marketing surveillance. (Image: iStock/PRImageFactory)

Related tags: Clinical research

The data-focused clinical research organization (CRO) Quanticate has upgraded its pharmacovigilance safety database ahead of EudraVigilance’s go-live in November.

Quanticate has updated safety data management and global safety database to the latest version of Oracle Argus​, v8,1.

According to the UK-based CRO, the investment anticipates the launch of an improved version of EudraVigilance – the European Medicines Agency’s (EMA) system for managing and analyzing information on suspected adverse reactions to medicines.

Compliant with Article 2(3) of Directive 2010/84/EU2, adverse reactions must be submitted electronically to the EudraVigilance database.

Per the EMA’s website​, the new version of EudraVigilance “is fully functional and ready to ​go live on 22 November 2017​.”

The enhancement of EudraVigilance follows the revised EU legislation on pharmacovigilance, which updated the legal framework for reporting and analysing suspected adverse reactions to improve health protection​,” according to the EMA.

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