Medical Device Link.

Originally Published EMDM March/April 2003

INDUSTRY NEWS

Clinical trials are a necessary step in the development of new medical technology, but they can delay the introduction of life-saving products into the marketplace. Electronic clinical data management (ECDM) systems can streamline data collection and analysis, along with other important tasks, and eliminate process inefficiencies to help bring products to market faster. One such solution is ECDM technology from Phase Forward (Maidenhead, Berks, UK), which offers companies in the medical device, pharmaceutical, and biotechnology sectors a seamless data collection, management, and intelligence system.

The company’s flagship product, InForm, integrates the operational functions of a clinical data management system in a user-friendly Internet-based software product. It offers real-time data visibility and edit checking, allowing clinical trials to proceed rapidly, accurately, and securely. To manage data that have been captured electronically or on paper, Phase Forward has developed Clintrial. The software allows users to compile data from various applications and online or hybrid systems, and to maintain and manage it across participating sites worldwide.

The company has also created Clintrace to collect, code, and analyze adverse events. Designed to help OEMs meet worldwide reporting requirements, Clintrace was recently upgraded to support the E2B(M) and M2 standards for the formatting and electronic submission of adverse-event data.

Proposed by the International Conference on Harmonization, which is composed of members of industry and regulatory bodies from the United States, the European Union, and Japan, these standards have been adopted by US FDA, Health Canada, the European Agency for the Evaluation of Medicinal Products, and others. “This upgrade to the Clintrace solution,” says Paul Cisternelli, vice president of marketing at Phase Forward’s US headquarters, “and the supplemental release of the new electronic case submissions module represent the first steps in bringing to market a complete end-to-end clinical and safety informatics solution.”

Phase Forward products are supplied as integrated or stand-alone systems based on each customer’s specific needs.
For more information, contact the company at Voyager Place, Shoppenhangers Rd., Maidenhead, Berks SL6 2PJ, UK; phone: +44 1628 640700; fax: +44 1628 779031; e-mail: info.uk@phaseforward.com; Internet: www.phaseforward.com.

Norbert Sparrow

Copyright ©2003 European Medical Device Manufacturer