Quanticate upgrades pharmacovigilance database

09-Jul-2017 - Last updated on 10-Jul-2017 at 15:58 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)

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.