Oracle Introduces Oracle(R) Argus Safety Japan 6.0

Oracle Introduces Oracle(R) Argus Safety Japan 6.0
Enhancements Help Health Sciences Companies Operating in Japan Improve Safety, Facilitate Compliance and Reduce Costs 

REDWOOD SHORES, CA, May 10, 2010 (MARKETWIRE via COMTEX) -- Oracle News Facts

--  Oracle today announced the availability of Oracle(R) 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.



Supporting Quote

--  "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."



Supporting Resources

--  Oracle in Health Sciences
--  Follow Oracle Health Sciences on Twitter
--  Become an Oracle Health Sciences Fan on Facebook


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SOURCE: Oracle Corporation