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Sentrx Goes Live With Electronic Submissions to FDA
Drug Safety Firm Approved for Adverse Event Case Reporting Through ESTRI Gateway
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Little Falls, NJ - April 4, 2005 - Sentrx, the leading provider of technology-enabled
solutions for global drug safety, announced today that it has successfully completed its electronic
submissions pilot with the U.S. Food and Drug Administration (FDA). Reporting of Individual Case
Safety Reports (ICSRs) is now in production through the FDA ESTRI Gateway on behalf of one of Sentrx's
clients, a Top 50 pharmaceutical company.
Sentrx operates Relsys International's Argus Safety™ system from its data center in Little Falls, NJ, and
hosts dedicated instances of the powerful pharmacovigilance software for more than half of its SafetyTrak®
Post-Marketing Safety Monitoring clients. After installing the Relsys Electronic Submissions Manager™
(ESM) and the Electronic Data Interchange (EDI) solution from Cyclone Commerce, Sentrx began sending test
files to the FDA. The company was then approved for the operational pilot, where both paper and electronic
reports were submitted in parallel. Continuous successful transactions led to approval for full-scale
production.
"We are pleased to support our clients in meeting the very latest regulatory requirements for electronic
adverse event reporting," said Joseph Albano, Chief Executive Officer of Sentrx. "It is through our
unique focus on drug safety and our highly skilled information technology team that Sentrx is a leader
in supporting electronic submissions to the FDA, even among global pharmaceutical companies and Contract
Research Organizations. We are now beginning a similar process with the European agency."
About Electronic Submissions
Electronic reporting of ICSRs is an initiative recommended by the International Conference of
Harmonization (ICH), a global standards organization that brings together the regulatory authorities
and experts from the pharmaceutical industry of Europe, Japan and the United States. The European
Agency for the Evaluation of Medicinal Products (EMEA), Japan's Ministry of Health, Labour and Welfare
(MHLW), and the FDA have initiated pilot testing with the industry, and the EMEA has mandated full
compliance with the new reporting obligation by November 2005.
The ESM module from Relsys enables electronic transmission of ICSRs directly from the Argus Safety™
system, so all case data remains behind a company's firewall until it is sent directly to the final
receiving partner. It ensures a closed and secure environment that complies with 21CFR Part 11, HIPAA,
and other privacy regulations and provides mapping to the ICH E2B standard format for safety data exchange.
Cyclone Commerce offers the EDI services needed to create secure collaborative connections from
pharmaceutical companies and their service providers to regulatory authorities. The company has
extensive experience in the health care industry and was recently selected by the FDA to develop an
electronics submissions gateway for New Drug Applications (NDAs).
About Sentrx
Sentrx is a leading provider of technology-enabled solutions and services for global drug safety. Its
mission is to manage the safety risks associated with developing and marketing pharmaceuticals. Through
its multilingual Safety Response Center, Sentrx delivers a unique combination of highly skilled people,
exclusive technology, and best practices in drug safety monitoring. To learn more about Sentrx, please
visit their website at www.sentrx.com, or call 1-888-399-8032, extension 261.
Contact:
Jill Notte
Director of Marketing
Sentrx
Overlook at Great Notch
150 Clove Road
Little Falls, NJ 07424
Phone: 973-812-7575 ext. 261
Fax: 973-812-9094
Website: www.sentrx.com
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