Enhancements Help Health Sciences Companies Operating in Japan Improve Safety, Facilitate Compliance and Reduce Costs
Redwood Shores, CA – May 10, 2010
Oracle today announced the availability of Oracle® Argus Safety Japan 6.0, the latest version of Oracle’s comprehensive pharmacovigilance solution for Japanese health sciences organizations and global companies conducting business in Japan.
Oracle Argus Safety Japan 6.0, part of the Oracle Argus Safety Suite, includes new capabilities that facilitate regulatory compliance and support pharmacovigilance operational excellence 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 (PSR), to the Pharmaceuticals and Medical Devices Agency (PMDA), and capabilities to support expedited and Periodic Safety Update Reports (PSURs) for the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The new release also enables additional Japan-specific business processes and provides comprehensive translation support and a localized interface to improve pharmacovigilance efficiency. Key updates in the release include:
Literature intake – improved literature data import, assessment, and Book-in;
Improved case forms - with lab data entry enhancements, MedDRA J encoding process enhancements, product notes for Japanese license categories, user-defined fields in the PMDA tab, and upgraded keyword search for product assessment;
Expanded reporting – with periodic safety reports on clinical studies, PSR updates, due-soon calculations, and Holiday Calendar to adjust report date schedule;
Increased localization – E2B Check-error messages, Worklists, regulatory reporting tools, and Personal Argus Status have all been localized.
“As health sciences organizations expand their global reach, they face new and ever-changing pharmacovigilance and safety requirements. Efficient and effective management of these processes is vital from both a safety and business perspective,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences. “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.”