Oracle Argus Safety Japan


Oracle Argus Safety Japan enables global pharmaceutical companies to fully integrate Japan into their worldwide business processes, enabling significant productivity benefits. Oracle Argus Safety Japan is a comprehensive solution that manages all Japanese reporting requirements.

Oracle Argus Safety Japan integrates seamlessly with Oracle Argus Safety, providing a single global database with unified workflow for management of worldwide drug safety information. Pharmaceutical companies realize productivity gains by eliminating double data processing efforts. Oracle Argus Safety Japan's truly global configuration also improves manageability and simplifies system maintenance for administrators.

Oracle Argus Safety Japan seamlessly integrates with Oracle Argus Interchange, meeting worldwide regulatory requirements for electronic submissions. Spontaneous, periodic, and clinical expedited reports can be easily transmitted to the Pharmaceuticals and Medical Devices Agency (PMDA).

Designed with advanced multi-language tools, Oracle Argus Safety Japan adds Japanese local fields to support Japanese requirements. Oracle Argus Safety Japan also supports Japanese translated code lists and contains a PMDA screen for Japan-specific case information. Translation support tools allow coded values to be automatically translated from Japanese to English, and vice versa. In addition, Oracle Argus Safety Japan includes MedDRA and MedDRA J browsers and supports the Japanese Drug Dictionary.