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Synteract Inc. Completes Upgrade Implementation of Safety Surveillance Platform and Electronic Submission Capabilities

SAN DIEGO - Aug. 8, 2007 - Synteract, a leading full service contract research organization, has completed implementation of version 4.5.2 of the Oracle Adverse Event Reporting System® (AERS) into its workflow process, to be used in pre- and post-marketing safety surveillance. Synteract also has registered with the FDA for electronic submission, providing its customers a more efficient and better safety reporting process. Oracle AERS® is a full-featured adverse event reporting system used to collect, monitor, and manage safety data from clinical trials, post marketing studies, and spontaneous reporters, including medical information requests, product complaints and adverse event reports. This latest version of Oracle AERS® offers integration with Oracle TMS®, E2B (electronic to business) enhancements, local reportability, and enhanced screens for product returns and complaints. 

Synteract also is registered with the FDA and has commenced testing its E2B Gateway for electronic submission of eCTD (electronic common technical documents) and ICSRs (individual case study reports) to the agency. These electronic submissions save several days time over traditional paper submission and improve the efficiency for clinical trials, since division routing at the FDA improves with electronic submission. Costs of express shipping and man-hours used to process reports are reduced or eliminated through use of the gateway. 

"The upgrade to Oracle AERS® at Synteract provides our company with the ability to more efficiently submit ICSRs to the European Medicines Agency (EMEA), as that agency has now mandated. Submitting through the gateway is a simple process," said Debra Porter, Manager, Pharmacovigilance, Pacira, a customer of Synteract's for six years. "I just select E2B from the report menu, insert the case number and within 30 minutes we have confirmation that the case has reached its destination! We're glad that Synteract also has added this e-submission to the FDA capability so it will be just as easy." Synteract offers secured web access to its E2B gateway as an Application Service Provider. This enables clients to perform electronic submissions through the gateway from any location, while Synteract provides the technical support and maintenance of the system.

About Synteract, Inc. 
Established in 1995, Synteract is a privately held, full-service contract research organization, dedicated to meeting the research, technology, safety, and post-marketing needs of biotechnology, biomedical, and pharmaceutical companies. Based in Carlsbad, California, the company provides expertise in a wide range of therapeutic areas with strong emphasis in oncology, central nervous system, cardiovascular disease, ophthalmology, anti-infectives, and pain. Since 2000, Synteract has been a key development shop for web, wireless, and voice data solutions that speed the completion of clinical trials and aid access to clinical trials information. This includes technologies such as electronic data capture (EDC), interactive voice response systems (IVRS), and automated safety tracking and reporting. 

For more information see: or call (760) 268.8200. 

Vince Madrid 


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