The Argus security database is a key a part of the Argus Security 3.0.1 pharmacovigilance software program system. In a nutshell, pharmacovigilance is outlined because the monitoring of any attainable opposed results of each natural cures and artificial medicine as they’re used.
The digital database is used to assist corporations guarantee compliance with international laws concerning pharmacovigilance and associated actions. As a complete pharmaceutical software program system, it helps pharmacovigilance enterprise processes that happen in each the pre- and post-marketing phases.
The Argus database is hosted in a knowledge heart that’s ISO-9001-certified, and operates in response to the safety requirements promulgated by FDA pointers. By managing this knowledge heart, a pharmaceutical agency or laboratory could get hold of most bodily knowledge safety in addition to entry to efficient knowledge backup and restoration procedures each time these providers are wanted.
ACCOVION, the full-service contract analysis group that gives pharmacovigilance as a core service, has configured the Argus database with custom-made and validated guidelines to expedite security reporting. This setup permits generated security stories to be despatched to regulatory investigators and central ethics committees.
The system covers a variety of essentially the most generally used types, together with the American FDA MedWatch 3500A type for medicine, the VAERS type for vaccines, the CIOMS-I type, and plenty of others utilized in European international locations.
The usual setup in use by the Argus security database system contains coding with present World Well being Group and MedDRA knowledge dictionaries, in addition to older variations of those dictionaries and plenty of others to fulfill consumer necessities.