Pharmaceutical companies operate in a highly regulated environment that requires tracking the safety profiles of drugs, both pre and post launch. Adverse Event Reporting systems are used to capture and monitor drug safety and study data. Implementing these systems is often a complex, large-scale engagement that can take years and often calls for specialist resources with significant experience in the necessary process, technical details and validation requirements.
Pfizer initiated an upgrade to their Adverse Event Reporting system, Argus Safety, to align with new compliance requirements and improve case processing flexibility. The upgrade required an assessment of the downstream reporting system – a custom-developed global safety data warehouse and a datamart layer to generate the reports.
Pfizer needed a partner who understood their business, their systems, and was able to deliver outstanding performance to a tight timeline in this most challenging area of pharmaceutical reporting.
