Phase Forward Announces FDA Contract Award for Production Rollout of WebSDM[TM] with Empirica[TM] Study.Contract Will Support Expanded Rollout of Phase Forward's WebSDM Product with Clinical Trials Signal Detection at FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. CDER CDER Center for Drug Evaluation and Research (US FDA)
CDER Centre de Développement des Energies Renouvelables (French)
CDER Client Development and Evaluation Report
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 a contract award to support the FDA's production rollout of the company's WebSDM[TM] Release 3.0 software, including the Empirica[TM] Study Clinical Trials Signal Detection system. The WebSDM tool was originally developed under a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).
A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) for the FDA to validate and review submission data in CDISC CDISC Clinical Data Interchange Standards Consortium 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.
Having a plane surface. Model (SDTM SDTM Study Data Tabulation Model
SDTM Straight Down the Middle (pinball wizard terminology) ) format, and has been installed at FDA since 2005. Empirica Study provides advanced statistical screening and visualization tools for review of SDTM data.
Under the contract, Phase Forward will be providing extended support, training, expanded statistical documentation for reviewers, software updates and enhancements to the Center for Drug Evaluation and Research's (CDER's) Computational Science Center (CSC) as it works to make standards-based review tools such as WebSDM more readily available to reviewers. The WebSDM solution is also installed at the National Cancer Institute (NCI See Liberate. ) for use with the FDA's Janus data warehouse.
"We're very pleased to have this opportunity to help CDER expand reviewers' use of WebSDM to help them more fully realize the benefits of standardized submission data in CDISC format," said Wayne Kubick, vice president for Phase Forward's Lincoln Safety Group and Lincoln's principal investigator for the original CRADA. "Over the past year, we have seen increased interest among reviewers in using Empirica Study's advanced signal detection capabilities, including Multivariate Bayesian Logistic Regression and its rich set of graphical visualizations with drilldown to facilitate exploration of lab, ECG ECG electrocardiogram.
Also called an electrocardiogram, it records the electrical activity of the heart. , vital signs, completion and adverse event data. This new contract will allow us to help reviewers further capitalize on the wider signal detection and analysis capabilities that these products can offer."
WebSDM, along with the Empirica[TM] suite of pharmacovigilance and risk management products, is managed by Phase Forward's Lincoln Safety Group, one of the most experienced and respected teams in the industry.
About Phase Forward
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. 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 300 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International, 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, Servier, SGS, Tibotec and the 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. . 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 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 of Phase Forward's products and services, future business and operations plans of Phase Forward customers, and future use of Phase Forward's products by the U.S. Food and Drug Administration (FDA). 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 to collaborate with regulatory agencies, discontinuation of the use of Phase Forward's products and services by customers or regulatory agencies such as the FDA, the possibility that customers' and regulatory agencies' needs or plans may change over time, and competition. 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 Annual Report on Form 10-K.