Drug Safety and Pharmacovigilance Safety Databases
A huge component of Drug-Safety are Safety Databases. They are the main repository for collected safety information for the company’s product(s), it facilitates the reporting of individual and aggregate safety data to authorities and third parties and provides a key source of information for ongoing detection of safety signals and evaluating the risk-benefit balance of the drug. In one word – it offers compliance. Let’s take a look at the few popular, most used safety databases.
1. ARGUS – Oracle Argus Safety
Currently with it’s 8.3 version, Oracle Argus keeps updating itself and the data elements. It’s user friendly interface is utilized by every company for their own customization. The reporting tool stores all the data and one can also retrieve/download as and when required. Every company/CRO gives a detailed training period when recruited as it’s not only essential for a Drug Safety Associate/Physician/ Medical Reviewer to perform but also a legal need.
2. ArisG
ArisG is less popular than ARGUS but often used in the Pharmacovigilance department. Despite being a data entry friendly database, it’s not a reporting tool. It’s used for Signal Detection with Empirica Signal and helpful in analyzing the data (a stark contrast over ARGUS).
Other Databases used in Drug Safety are:
3. PvNET
PvNET records the adverse events and also analyzes and generates the regulatory reports. It’s E2B compliant.
4. RepClinical
repClinical helps the drug safety personnel to enter adverse events, generate regulatory reports and also exchange the ICSRs with multiple regulatory bodies in a simple way.
5.VigiBase and Spectra
VigiBase and Spectra are other drug safety databases shown to be largely used in the last couple of years – 2019 and 2020 by Pharmaceutical companies.
