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 firstname.lastname@example.org