Oracle Expands Clinical Safety Monitoring and Reporting Capabilities with Oracle Argus 8.0 Solutions


Applied Clinical Trials

DIA 2015-Washington DC-Jun 16, 2015

Oracle Health Sciences today announced the availability of Oracle Argus Standard Edition 8.0, Oracle Argus Enterprise Edition 8.0, and Oracle Argus Safety Japan 8.0-major new Oracle Argus releases for sponsors and manufacturers of pharmaceuticals, medical devices, and vaccines, as well as contract research organizations and health authorities.

This latest release of Oracle’s extensive pharmacovigilance platform is designed to help safety organizations comply with new reporting regulations, including those from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2B(R3) and U.S. Food and Drug Administration (FDA) Electronic Vaccine Adverse Event Reporting System (eVAERS), while providing greater reporting capability and flexibility over previous versions.

Oracle Argus Standard Edition 8.0 introduces the ICH E2B(R3) and FDA eVAERS expedited reports, which are designed to support compliance with new legal requirements for adverse event reporting. The solution also features new integration with Oracle Business Intelligence Publisher for more-flexible periodic reports and with the Oracle B2B gateway for transmitting expedited reports to the regulatory authorities, according to legal requirements.

Oracle Argus Enterprise Edition 8.0 includes all of the components, and therefore, all the benefits, of Oracle Argus Standard Edition 8.0. In addition, it supports enhanced ad hoc reporting, point-in-time querying, and additional self-service analysis on the periodic report data set. These features are made possible through new and enhanced integration with Oracle Argus Safety, Oracle Argus Mart, Oracle Argus Insight, Oracle Business Intelligence Enterprise Edition, and Oracle Health Sciences Empirica Signal. The new features enable better understanding of the aggregate data and allow safety organizations to reduce the costs of creating and maintaining reports over time.

Oracle Argus Safety Japan 8.0 supports compliance with new Japanese reporting regulations, including the Japan Development Safety Update Report (J-DSUR), as well as enhancements to the expedited and periodic regulatory reports for the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The solution also helps to improve workflow by introducing the Local Case Lock feature, allowing case processing centers in Japan to work more efficiently with their counterpart centers in the rest of the world.

“Today, safety and pharmacovigilance regulations are undergoing significant changes and becoming more complex than ever before,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. “Oracle Argus 8.0 helps our customers maintain or increase compliance, gain actionable insights into their data, and lower their total cost of ownership, while addressing the full set of global safety challenges.”

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