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,
-- 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
-- "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."
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SOURCE: Oracle Corporation