Phase Forward Enhances Clinical Adverse Event Reporting and Regulatory Compliance; Clintrace 4.1 Features Reporting Capabilities Achieved Through Integration with Cognos ReportNet, Compliance with FDA MedWatch 3500A Guidelines
WALTHAM, Mass.–(BUSINESS WIRE)–Sept. 5, 2006–Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the immediate availability of a new version (4.1) of the Clintrace(TM) adverse event tracking and reporting system. A comprehensive solution for safety data collection, management and submission, Clintrace 4.1 features reporting capabilities that are the result of tight integration with Cognos, Inc.’s ReportNet product. The Clintrace Reporting Workspace (the integration with ReportNet) will provide additional reporting on adverse event and operational information with enhanced data analysis capabilities.
Clintrace 4.1 also features compliance with the FDA’s new MedWatch 3500A changes ahead of the November 1, 2006 FDA-mandated deadline. MedWatch 3500A is the latest version of the on-line form for the mandatory reporting of serious adverse events, potential and actual medical product errors, and product quality problems associated with the use of FDA-regulated drugs, biologics, devices and dietary supplements.
“We are very impressed with the seamless integration of Cognos ReportNet with Clintrace, which Phase Forward has achieved in version 4.1,” said Bill Stevens, senior director of life sciences solutions at Cognos. “Cognos ReportNet provides a single authoring environment for creating reports to improve decision-making and increase business agility. Combining Cognos ReportNet with Clintrace adverse event tracking and reporting system represents a powerful solution that will enable Phase Forward customers to build their own reports without IT involvement.”
“Phase Forward continues to invest in our market-leading solutions for data capture, data management and safety for our global customers,” said Bob Weiler, president and chief executive officer, Phase Forward. “We recently announced our newest version of the Electronic Case Submissions Module (ECSM), which together with Clintrace streamlined the exchange of information with regulatory agencies, affiliate offices and trading partners. With Clintrace 4.1, we’ve enabled our customers to prepare ad hoc reports in a self-service environment, adding much-needed flexibility and opportunities for cost and time savings. And we’re ahead of upcoming FDA requirements, specifically for MedWatch 3500A changes, providing ease in compliance with regulatory guidelines for collecting information, creating reports and meeting deadlines for adverse events.”
Availability
Clintrace 4.1 is available immediately, along with implementation and migration services for new and existing Clintrace users. For additional details, visit: www.phaseforward.com.
About Phase Forward
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company offers proven solutions for electronic data capture (InForm(TM)), clinical data management (Clintrial(TM)), clinical trials signal detection (CTSD(TM)), strategic pharmacovigilance (WebVDME(TM) and Signal Management), adverse event reporting (Clintrace(TM)) and applied data standards (WebSDM(TM)). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 230 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, Food and Drug Administration, GlaxoSmithKline, Merck, U.K. Medicines and Healthcare Products Regulatory Agency, National Institutes of Health, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Serono and Servier. Additional information about Phase Forward is available at www.phaseforward.com.
