Pharmacovigilance-focused contract researcher Accovion has configured Oracle's Argus database with validated rules to expedite safety reporting. The system allows for compliant user transfer of safety reports to regulators and ethics committees.
The Argus database, hosted in an ISO-9001 data center, conforms with FDA security standards, says Boosh News. The set-up provides physical data security as well as access to data backup and recovery capabilities.
The system encompasses such forms as the MedWatch 3500A for drugs, the VAERS form for vaccines, and others. The standard set-up in use by the Argus safety database system includes coding with current World Health Organization and MedDRA data dictionaries, as well as older versions.
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