The Argus safety database is a key part of the Argus Safety 3.0.1 pharmacovigilance software system. In a nutshell, pharmacovigilance is defined as the monitoring of any possible adverse effects of both herbal remedies and synthetic drugs as they are used.
The digital database is used to help companies ensure compliance with global regulations regarding pharmacovigilance and related activities. As a comprehensive pharmaceutical software system, it supports pharmacovigilance business processes that take place in both the pre- and post-marketing phases.
The Argus database is hosted in a data centre that is ISO-9001-certified and operates according to the security standards promulgated by FDA guidelines. By managing this data centre, a pharmaceutical firm or laboratory may obtain maximum physical data security as well as access to effective data backup and recovery procedures whenever these services are needed.
ACCOVION, the full-service contract research organization that offers pharmacovigilance as a core service, has configured the Argus database with customized and validated rules to expedite safety reporting. This setup enables generated safety reports to be sent to regulatory investigators and central ethics committees.
The system covers a wide range of the most commonly used forms, including the American FDA MedWatch 3500A form for drugs, the VAERS form for vaccines, the CIOMS-I form, and many others utilized in European countries.
The standard setup in use by the Argus safety database system includes coding with current World Health Organization and MedDRA data dictionaries, as well as older versions of these dictionaries and many others to meet user requirements.