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
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
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
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 firstname.lastname@example.org
SOURCE Synteract Inc.