Sentrx Goes Live with Electronic Submissions to FDA: Drug Safety Firm Approved for Adverse Event Case Reporting Through ESTRI Gateway

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Sentrx 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 SentrxÂ?s clients, a Top 50 pharmaceutical company. Sentrx has initiated a similar approval process with the European Agency for the Evaluation of Medicinal Products (EMEA).

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 http://www.sentrx.com, or call 1-888-399-8032, extension 261.

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Jill Notte
SENTRX
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