Oracle Health Sciences Application Chosen for Food and Drug Administration (FDA) Adverse Event Reporting System


  ·         In its role as prime contractor for the 

 task order awarded in support of the FDA, SRA Corporation, a wholly owned subsidiary of SRA International, Inc., has selected the 

.
  ·         Oracle Adverse Event Reporting System was selected as the solution that best met the requirements for a FDA Adverse Event Reporting System.
  ·         Life Science organizations and regulators use the Oracle Adverse Event Reporting System to proactively manage the safety of both clinical and marketed products.
  ·         The FDA is planning to use the application to help track safety issues and incidents once products are available on the market.
  ·         As part of the evaluation criteria, the functional fit of the products were examined by assessing how well they met the system requirements.
  ·         Products were also evaluated for their technical capability, including assessments of the following areas: performance and scalability; extensibility and flexibility; platform requirements; established methodologies for deployment; security; reliability and availability.


  ·          “We are pleased to help the FDA meet its objective of acquiring a solution that provides post-market product safety surveillance capabilities as well as an improved methodology for submitting potential adverse events, analyzing individual safety and product quality reports, and delivering enhanced signal detection and management,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences. “We look forward
to working closely with SRA and the FDA to help make the FDA Adverse Event Reporting System project successful.”

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Oracle Adverse Event Reporting Data Sheet