A Top 10 global pharmaceutical company has gone live on PV Signal for end-to-end Signal Detection and Management

13 Sep 2022

The company will replace their legacy system and move to RxLogix PV Signal for all signaling needs on internal and external data sources.

  • More than 300+ Users
  • Load company’s Internal Safety data into RxLogix PV DataHub using standard ETL process from company’s cloud to RxLogix Cloud
  • Data review from external databases like FAERS and EVDAS
  • Complex data migration included migration of alerts and signal histories
  • Qualitative and Quantitative Signal Detection
  • APIs based integration for loading batch data from external system and PSUR groups from safety system
  • Batch signal detection
  • Highly innovative Decision Support System
  • Ad-hoc data mining and monitoring on additional variables like country, indication, years etc.
  • Transition of manual Qualitative and EVDAS review to electronic review in PV Signal application
  • Integrated PV Analytics implementation for dynamic data analysis and visualizations
  • Validation of safety observations from signal detection activities
  • Allow structured and user-friendly management and documentation of signal investigations performed according to defined processes
  • Allow generation of detailed aggregate signal overviews
  • Improve Inspection readiness