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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. -- Phase Forward (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: 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 ECSM Electrochemical Spark Machining
ECSM Elliptic Curve Scalar Multiplication
ECSM Electrochemical Scanning Microscopy
). 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 adhere to
verb 1. follow, keep, maintain, respect, observe, be true, fulfil, obey, heed, keep to, abide by, be loyal, mind, be constant, be faithful

2.
 the FDA's latest Electronic Submission Gateway (ESG ESG Enterprise Strategy Group (Veritas)
ESG Emergency Shelter Grant (Florida, USA)
ESG Expeditionary Strike Group
ESG Electronic Service Guide (used in DVB) 
) standards. The latest version of the ECSM takes advantage of features of the new FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 ICSR International Conference on Software Reuse
ICSR International Conference on Shellfish Restoration
ICSR Individual Case Safety Report
ICSR International Center for Standards Research (University of Colorado) 
) 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 (programming) beta testing - Testing a pre-release (potentially unreliable) version of a piece of software by making it available to selected users. This term derives from early 1960s terminology for product cycle checkpoints, first used at IBM but later standard throughout the  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 CTSD Crew and Thermal Systems Division
CTSD Certified Trading System Developer
CTSD Computer Test Sequences Document (NASA)
CTSD Coordinate Transformation System (NASA)
CTSD Combat Training Support Directorate
(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 Process optimization is the practice of making changes or adjustments to a process, to get results.

Optimization is the use of specific techniques to determine the most cost effective and efficient solution to a problem or design for a process.
, 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 The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. , National Institutes of Health, Procter & Gamble, Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History
Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees.
, sanofi-aventis, Schering-Plough Research Institute, Serono and Servier. Additional information about Phase Forward is available at www.phaseforward.com.

Certain statements made in this press release that are not based on historical information are forward-looking statements which are made pursuant to the safe harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. This press release contains express or implied forward-looking statements relating to, among other things, the performance and features of Phase Forward's products and services, future business and operations plans of a Phase Forward customer, and the ability of Phase Forward's customers to realize benefits from the use of Phase Forward's products and services. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond Phase Forward's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the ability of Phase Forward's customers to realize benefits from the use of its products and services, changes in regulatory requirements applicable to Phase Forward's customers and the manner in which they conduct business, changes in commonly used industry standards, and the possibility that customers' needs or plans may change over time. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Phase Forward undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by Phase Forward, see the disclosure contained in Phase Forward's public filings with the Securities and Exchange Commission including, without limitation, its most recent Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Aug 10, 2006
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