Oracle Argus Safety Japan 6.0, part of the Oracle Argus Safety Suite, includes new capabilities that facilitate regulatory compliance and support pharmacovigilance operational initiatives specifically for companies operating in Japan.

With a single global database for safety, reporting and analytics, and a global workflow that facilitates compliance and safety, Oracle Argus Safety Japan 6.0 reduces IT overhead and enables significant process efficiencies that helps to drive down pharmacovigilance costs.

Oracle Argus Safety Japan 6.0 provides comprehensive coverage of Japanese regulatory reports, expedited and periodic safety report, to the Pharmaceuticals and Medical Devices Agency, and capabilities to support expedited and periodic safety update reports.

The new release also enables additional Japan-specific business processes and provides translation support and a localized interface to improve pharmacovigilance efficiency. Key updates in the release include: literature intake; improved case forms; expanded reporting; increased localization.

Neil Crescenzo, senior vice president and general manager of Oracle health sciences, said: “As health sciences organizations expand their global reach, they face new and ever-changing pharmacovigilance and safety requirements. The management of these processes is vital from both a safety and business perspective.

“Oracle Argus Safety Japan 6.0 enables integration of the global pharmacovigilance business process, supports international regulatory compliance and provides new market-specific capabilities for companies operating in Japan.”

How far the new release will help Japanese sciences firms?

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