Following established guidelines, data from source documents sent by clients is processed (data entry and MedDRA coding) in to a Drug Safety/Pharmacovigilance database, after a duplicate search, on behalf of the clients. This may involve an initial triage and a subsequent medical review/assessment of the report by physicians. Once finalized, the case reports are submitted to the regulatory authorities/business partners. QSI’s scientists have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases.
QSI also has expertise in processing adverse reactions reports from veterinary medicinal products (veterinary pharmacovigilance) across different therapeutic areas.