EDC Oracle Clinical Data Management

technology data sheets

Oracle Argus Safety

Oracle Argus Safety 8.0 is the market leader in managing drug safety and pharmacovigilance.


  • Provides efficient processing of AEs and SAEs
  • Generates the CIOMS and MedWatch reports as well as any other standard report forms required by different regulatory authorities worldwide
  • Helps to produce SAE narratives in accordance with the ICH guidelines. The system can analyze AE and SAE reports from different perspectives such as expedited and periodic reporting, signal detection and management and clinical trial SAE reconciliation.
  • Ffull integration with the latest MedDRA and WHO Drug dictionaries and is fully ICH E2B compliant
  • Uses a state-of-the art Oracle 11g 64-bit database
  • Clients can enter and modify data with a web interface.
  • Hosted by ClinDatrix.