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Phase Forward Unveils Expanded Clinical Trials Signal Detection System.


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
 2.0 Adds New Functionality to Clinical Trial Data Screening Using CDISC CDISC Clinical Data Interchange Standards Consortium  SDTM SDTM Study Data Tabulation Model
SDTM Straight Down the Middle (pinball wizard terminology) 
, Designed for High Quality Pharmacovigilance During Clinical Development

LAS VEGAS Las Vegas (läs vā`gəs), city (1990 pop. 258,295), seat of Clark co., S Nev.; inc. 1911. It is the largest city in Nevada and the center of one of the fastest-growing urban areas in the United States.  -- 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 company's Clinical Trials Signal Detection (CTSD[TM]) system. Briefly, the CTSD system enables clinical safety and medical monitoring staff to:

* analyze clinical data for the purpose of detecting, evaluating and tracking potential safety signals

* screen clinical data for safety issues, including the detection of clinical syndromes

* develop safety profiles for new compounds as early as Phase II clinical trials

* make informed decisions earlier in the development process, creating opportunities for reducing development costs and potential acceleration of a drug's time-to-market

CTSD 2.0 offers functionality for detecting clinical syndromes with a newly developed issue cluster mining technique, enhanced statistical tools such as multivariate Bayesian logistic regression In statistics, logistic regression is a regression model for binomially distributed response/dependent variables. It is useful for modeling the probability of an event occurring as a function of other factors. , and expanded signal tracking and data visualization options.

The system is also integrated with the company's WebSDM[TM] (Web Submission Data Manager) platform to offer seamless support for the Clinical Data Interchange Standards Consortium Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of  (CDISC) Study Data Tabulation tab·u·late  
tr.v. tab·u·lat·ed, tab·u·lat·ing, tab·u·lates
1. To arrange in tabular form; condense and list.

2. To cut or form with a plane surface.

adj.
Having a plane surface.
 Model (SDTM) data standard. The CDISC standard is used to support the CTSD product's advanced data mining functions.

"The collateral benefit of applying the CDISC data standard for electronic submissions to additional applications is clear," said Becky Kush Kush: see Cush. , president of CDISC. "We expect the CDISC standard to assist with many challenges within the pharmaceutical industry requiring data interoperability - and the application of the CDISC standard to drug safety in clinical trials, as demonstrated by CTSD, is an excellent example."

"CTSD offers our customers an additional level of insight," said Bob Weiler, president and chief executive officer, Phase Forward. "By enabling our customers to flag potential risks earlier in the clinical trial phase - long before widespread patient exposure to a drug - the product supports improved drug safety and helps manage development costs. With CTSD 2.0 we continue to provide the industry with the tools needed to put safety at the forefront of every development effort."

About CTSD

A 2006 Bio-IT World Life Sciences Conference and Expo "Best of Show" winner, the CTSD system provides a library of predefined and customizable tests that tailor signal detection algorithms to the unique requirements of clinical trial data. The tests automate screening of clinical trial data for disproportional dis·pro·por·tion·al  
adj.
Disproportionate.



dispro·por
 occurrences of safety-related events between the study drug and comparator comparator

Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies.
 groups - and because the CTSD data repository uses the SDTM standard, all screening tests can be applied to individual studies or pooled studies. In addition, the system's graphical and tabular forms make it easier for medical reviewers without specialized statistical training to pool and analyze data across multiple studies, a normally time-intensive but FDA-required task.

Availability

CTSD 2.0 is available immediately, along with implementation and migration services for existing CTSD and WebSDM users. For additional information, please 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 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, Phase Forward's expectations concerning industry standards applicable to its business, the performance and acceptance of Phase Forward's products, and the benefits to customers from such combined offering. 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, Phase Forward's inability to convince current and potential customers to order its products and services, the failure of customers to realize benefits from the use of these products and services, changes in industry standards, and changes in regulatory requirements applicable to Phase Forward's customers and the manner in which they conduct business. 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:Oct 17, 2006
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