SRA Selects Oracle Adverse Event Reporting System
Oracle Health Sciences Application Chosen for Food and Drug Administration (FDA) Adverse Event Reporting System
Redwood Shores, CA-May 14, 2009
News Facts:
· In its role as prime contractor for the U.S. General Services Administration 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.
· 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.
Supporting Quote
· “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.”
Supporting Resources:
· SRA Recognized by Fortune as a Best Company to Work For
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
