Chalk up two wins for Oracle: SRA Corp. has selected the software giant's Adverse Event Reporting system for an FDA project, while contract research organization Gleaneagles CRC has chosen Oracle Clinical and Oracle's Siebel Clinical Trial Management System.
SRA, as prime contractor for the U.S. General Services Administration, is supporting the FDA in developing its adverse event reporting system. The Oracle software helps users manage safety aspects of both clinical and marketed products. The FDA is said to be planning to use the application to help track safety issues and incidents for products on the market.
Senior VP Neil de Crescenzo says in an announcement that the FDA is planning post-market product safety surveillance capabilities as well as an improved methodology for submitting adverse events, analyzing individual safety and product quality reports, and delivering enhanced signal detection and management.
For Gleneagles CRC, the choice was Oracle Clinical software and its Siebel Clinical Trial Management System for operational efficiencies and to meet growth expectations. Gleneagles has a network of investigators and sites across Asia and Australasia. According to an announcement, Oracle Clinical's integration with the Oracle Database was a factor in the decision.