Pfizer and Ness partner to take on complex technical challenges
Pfizer and Ness partnered to conduct a comprehensive technical assessment of a new Adverse Event Reporting System to successfully upgrade the complex custom downstream safety data warehouse.
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.
Ness is uniquely qualified to address these types of upgrades, offering extensive knowledge in the drug safety domain and the safety systems at Pfizer. Ness has many years of verified experience delivering enterprise-level safety system projects (including successful implementations of Argus Safety), as well as experience in building and maintaining data warehouses with safety aggregate reporting.
The comprehensive technical assessment of changes in the new Argus Safety release, was followed by an equally intensive assessment of the downstream system, in order to develop detailed requirements to then design, code and test the final solution.
Ness was able to deliver a quality product within the required timeframe. Our team continues to find new ways to add value, by presenting creative and flexible solutions to the kinds of challenges posed by large-scale technical projects.
Ness was able to inject quality and rigor throughout the overall project and remains a valued partner of Pfizer.