Synteract Inc. Enhances Safety Reporting Capabilities With Cyclone Commerce Interchange for Electronic Submissions

    CARLSBAD, Calif., Dec. 12 /PRNewswire/ -- Synteract, Inc. announces
 successful installation and full validation of Cyclone Commerce Interchange
 version 5.3, allowing for full electronic submission capability to drug
 regulatory agencies.
     Cyclone Interchange helps ensure compliance with the submission of
 regulated data to the FDA, EMEA and MHLW.  Cyclone Interchange dramatically
 improves the conventional submissions process with non-intrusive, standards-
 based software designed to enable, track, monitor and report on submissions
 activity. It ensures the privacy and security of electronic submissions and
 provides further compliance assistance with data retention and archiving for
 auditing purposes.
     Synteract uses Oracle Adverse Event Reporting System(R) (AERS) to perform
 safety surveillance, management of medical information requests, product
 complaints and adverse event reports.  Together, Cyclone Interchange and
 Oracle AERS provide a highly flexible, comprehensive solution for importing,
 exporting, submitting, and monitoring Individual Case Safety Reports (ICSRs)
 using the E2B interchange standard.  Synteract's Safety Department specializes
 in the performance of pharmacovigilance services, such as case entry, safety
 monitoring and assessment, regulatory submission and reporting, and safety
 database management.
     Synteract also offers secured access to Cyclone Interchange as an
 Application Service Provider (ASP).  This allows clients the ability to submit
 ICSRs through Cyclone Interchange from any location, while Synteract provides
 the technical support and maintenance of the system.
     "The software solutions offered by Synteract are indicative of our
 commitment to efficient and compliant processes for electronic transmission.
 Cyclone Interchange and Oracle AERS streamline the pharmacovigilance
 procedures related to electronic adverse event reporting, adding value and
 further enhancing our end goal to reduce time to product market for our
 clients through the accurate and timely communication of clinical study data,"
 stated Stewart Bieler, Vice President of Clinical Operations at Synteract.
 
     About Synteract Inc.
     Established in 1995, Synteract is a privately held, full-service contract
 research organization, dedicated to meeting the various needs of
 biotechnology, biomedical, pharmaceutical, and drug industry firms.  Based in
 Carlsbad, CA, with a branch office in Pennsylvania, the Company provides
 expertise in a wide range of therapeutic areas and maintains a wealth of
 knowledge in oncology, ophthalmology, HIV, sexual dysfunction, cardiovascular
 disease, 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 assist in 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.  Synteract has
 offices in Carlsbad, CA and Philadelphia, PA.  For information please visit us
 at or call (760) 268.8200. http://www.synteract.com/
 
     CONTACT:  Vince Madrid, +1-760-268-8069 vmadrid@synteract.com
 
 

SOURCE Synteract Inc.

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