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REDWOOD SHORES, Calif.
08-OCT-2002 06:00 AM
Oracle Corporation (NASDAQ: ORCL), the world's largest enterprise software company, showed its ongoing commitment to the pharmacovigilance space with today's announcement on the availability of the Oracle(r) Adverse Event Reporting System (AERS) 4.3. Originating with the acquisition of Netforce and the EventNet product last January, Oracle has equipped its Life Sciences offering with a complete solution for drug safety monitoring and reporting.
Manufacturers of medical products such as drugs, vaccines, biologics, gene therapies and medical devices, are required by law to report all adverse reactions to their products in a timely fashion to all countries where their products are marketed or studied. In order to manage the quality assurance analysis that results from an adverse event or product complaint, companies require an integrated business system and software to manage both processes.
Oracle's safety solution provides the capabilities to manage the reporting and analysis of serious adverse events, product complaints, and medical communication. By utilizing an integrated complaint management system for all product grievances from both clinical and spontaneous sources, companies can more efficiently communicate and manage their compliance processes.
As an integral part of the Oracle Pharmaceutical Application (OPA) suite, Oracle AERS supports the requirement for companies to maintain consistent safety profiles between their safety systems and their clinical data management systems. When installed together, Oracle AERS, Oracle Clinical, and Oracle Thesaurus Management systems can share common data elements and reference dictionaries. The adverse events recorded during clinical trials are thus entered consistently in the two systems, thereby improving timeliness, quality and accuracy.
"With spiraling costs for drug development and an ever-present concern for patient safety, companies need to streamline their reporting systems for adverse events, product complaints and medical communication," said Keith Howells, vice president, Oracle Pharmaceutical Applications. "AERS is an integrated solution enabling companies to satisfy regulatory compliance and accelerate the clinical trials process to reduce the time to market for new drugs."
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