Phase Forward Continues to Put Safety First; Company’s Electronic Case Submissions Module 2.0, Available Immediately, Offers Streamlined Safety Reporting and Enhanced Security; Complies with FDA’s Gateway Submission Standards
WALTHAM, Mass.–(BUSINESS WIRE)–Aug. 10, 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 (2.0) of the Electronic Case Submissions Module (ECSM). The ECSM, together with the Clintrace(TM) adverse event tracking and reporting system, provides a comprehensive solution for safety data collection, management and submission. The ECSM streamlines the exchange of electronic case safety information with regulatory agencies, affiliate offices and trading partners. Version 2.0 is designed to adhere to the FDA’s latest Electronic Submission Gateway (ESG) standards. The latest version of the ECSM takes advantage of features of the new FDA ESG and offers benefits including expanded submissions tracking and acknowledgements via integration with Clintrace, and enhanced application security.
The ECSM allows Clintrace system users to improve the efficiency of electronic Individual Case Safety Report (ICSR) submissions while maintaining existing workflows. From an ECSM-enhanced system, users can more easily monitor the process of both traditional paper-based reporting and electronic safety reporting.
“We share Phase Forward’s dedication to drug safety,” said Stefano Nodari, Information Technology R&D, associate director, Bracco Group, a pharmaceutical company and leading developer and supplier of advanced contrast imaging media for medical diagnostics. “The new ECSM gateway will help us submit adverse event reports electronically with ease and at a reduced cost, and will ensure that our reports are in compliance with the FDA’s latest submission standards. During our beta testing experience, these benefits were evident.”
“We continue our commitment to pharmacovigilance and drug safety,” said Bob Weiler, president and chief executive officer, Phase Forward. “Our goal is to help our customers streamline the complexities of data collection and adverse report submission. The ECSM Version 2.0 utilizes technology innovation to help our customers meet the industry’s regulatory requirements and submission standards.”
The new features of the ECSM 2.0 include:
— Expanded submissions tracking and acknowledgements functionality
— Compliance with the FDA’s latest AS2 ESG submission standards
— Compliance with submission standards for regulatory agencies in Europe and Japan
— Enhanced application security and digital certificate support
The ECSM 2.0 is available immediately, along with implementation and migration services for Version 1.2 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.
