The executive team at a Top 5 Global Biotech Company knew that their outsourcing model of utilizing multiple CROs to assist with their drug safety needs was not only inefficient, but was also expensive and jeopardizing case quality. In addition, contrasting processes between their offices in Germany, Switzerkand and the US resulted in difficulties while synchronizing conventions between locations, causing losses in productivity and quality on a global scale.
Facing a rapidly approaching deadline for an upcoming Periodic Safety Update Report(PSUR), a fas growing, medium-sized specialty pharma company based on the West Coast did not have the resources to handle the significant number of backlog ICSRs that needed to be processed and included in the report. The prospect of processing all the required backlog cases whicle simultaneously compiling the PSUR with a deadline one month away was unfeasible without additional support.
With the implementation of ARISg and agXchange in 2008, Gedeon Richter reaped immediate benefits by enabling their Pharmacovigilance activities to be planned and managed more effectively, ultimately improving efficiencies and regulatory compliance. Although these enhancements were noticed, the backlog safety cases that were processed on paper prior to the adoption of the new system continued to pose serious issues with compliance. Regulatory authorities have expressed concern for backlog reporting on many occasions and Gedeon Richter’s incomplete database made in-depth data analysis, appropriate presentation for PSUR compilation and benefit-risk assessment very difficult tasks to efficiently undertake.
