eShowcase: Clintrace 4.1

November 1, 2006

Applied Clinical Trials

Volume 0, Issue 0

Release takes adverse event reporting to a new level, complies with FDA's new rules

Release takes adverse event reporting to a new level, complies with FDA's new rules

Phase Forward Inc.(Waltham, MA) released version 4.1 of its adverse event reporting and regulatory compliance solution software, Clintrace. A result of Clintrace's integration with Cognos Inc.'s ReportNet software, Clintrace now has additional adverse event and operational information reporting capabilities, as well as enhanced data analysis capabilities. Clintrace 4.1 also features compliance with FDA's MedWatch 3500A form, the new online mechanism for mandatory reporting of serious adverse events, potential and actual medical product errors, and product quality problems involving FDA-regulated drugs, devices, biologics, and dietary supplements.

Clintrace 4.1

The integration with Cognos ReportNet, which offers a single authoring environment for creating reports to improve decision making, will let Clintrace users build their own reports without IT involvement. This, the company says, will afford added flexibility and cost- and time-saving opportunities.

Phase Forward Inc., (888) 703-1122, www.phaseforward.com