In an increasingly global environment, drug safety departments have been making significant investments in implementing common processes and systems to support operations in all regions.
This may entail deploying local tracking systems for initial receipt and final submission, integrated with a centralized core case processing system.
With the wider user base and generally increasing year-to-year case volumes, the focus of these systems is on efficiencies of single case processing and retrieval.
However, there are multiple business needs requiring fast reporting and analysis spanning cumulative safety data.
In addition to the basic regulatory need for compilation of periodic safety update report listings, companies need to analyze consolidated processing data across operating units to monitor compliance or look at metrics to effect resource and operational efficiencies.
Finally, companies also need a platform for maintaining other available large-pool safety data from external sources to utilize in signal detection and benefit-risk management activities.