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news.As part of its efforts to develop an electronic submission process for new drug applications, the Food and Drug Administration has awarded a contract to GlobalNet Services, a IT systems integrator.
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In partnership with Cyclone Commerce, GlobalNet will work to centralize the receipt of submissions from regulated industry and other government agencies into a single system. According to InformationWeek, the FDA Electronic Submissions Gateway project is expected to be worth around $2m.
In order to carry out this project, GlobalNet will use Cyclone Commerce’s B2B platform, Cyclone Interchange, and its transaction visibility solution Cyclone Director to make the exchange of new drug approval documents secure.
The gateway comes as health-care and pharmaceutical companies are being urged to replace paper-based processes with electronic business transactions. It is hoped that this will accelerate the approval process and establish relationships with trading partners.
The project will aim for an initial rollout in June, when pharmaceutical makers will be able to submit approval documents to the FDA’s Center for Drug Evaluation and Research (CDER). It is expected to be completed by the middle of 2006, when the FDA intends to replace different electronic document submission systems that regulate medical products and devices with a single, centralized entry point.
As well as contributions from Cyclone, the new system will be built with Sun Microsystems servers, Solaris Oracle9i databases and Radware equipment. It is thought that it will eventually handle about 25 submissions concurrently.