Phase Forward and Sentrx Partner to Offer Integrated Drug Safety Services
Sentrx will offer Phase Forward's Clintrace(TM), a Web-based adverse event tracking and reporting system, along with the Electronic Case Submission Module (ECSM), within its Safety Data Services offering and in conjunction with Sentrx Drug Safety Services. The two companies plan to explore other synergies in their offerings as well.
The partnership brings together Phase Forward's leading comprehensive solutions for managing the drug, device and vaccine safety process during key stages of development and marketing with Sentrx's operational expertise in pharmacovigilance. The offering will provide customers with secure access to Clintrace through the Sentrx Managed Safety System Hosting Center, along with outsourced adverse event case processing. Sentrx will also implement Clintrace ECSM, providing clients with the capability to submit adverse event reports electronically to regulators and exchange safety information with affiliates and trading partners.
"Sentrx is highly regarded for its expertise and technology solutions used for clinical trial safety monitoring and post-marketing safety surveillance," said Chan Russell, president of Phase Forward's Lincoln Technologies safety division. "Our customers and prospects appreciate the value and flexibility of working with specialized partners that offer Phase Forward software as an outsourced service, in conjunction with their own focused processes and consulting experience."
"This relationship aligns Sentrx with the market leader across the full spectrum of data collection and drug safety products," said Joseph Albano, chief executive officer of Sentrx. "As specialists in drug safety, we are particularly impressed with the leading-edge technologies developed by Phase Forward's Lincoln Technologies safety division and look forward to exploring additional synergies in signaling and clinical data management."
According to Uwe Trinks, chief information officer of Sentrx, "The Clintrace product's Web-based capabilities will allow our clients direct access to their safety data, with a flexible level of involvement in adverse event reporting and pharmacovigilance processes. The level of access can be configured to meet the needs of small- and mid-sized pharmaceutical and biotech companies that have limited resources but want the benefits of a full pharmacovigilance team."
About Phase Forward's Clintrace 4.1 Solution
A comprehensive solution for safety data collection, management and submission, the Clintrace software features integration with Cognos, Inc.'s ReportNet product, providing additional reporting on adverse event and operational information with enhanced data analysis capabilities. The product's enhanced, Web-based reporting capabilities offer unique capabilities to provide ad hoc reporting and on-demand query support for customers. Clintrace 4.1 also features compliance with the latest version of the FDA's online MedWatch 3500A form for the mandatory reporting of serious adverse events, product use and quality problems.
About Sentrx Safety Data Services
To enable the adverse event reporting process, Sentrx provides companies of every size access to the most advanced safety database technology and expertise available in the industry. Sentrx manages all aspects of pharmacovigilance data, including safety system hosting, configuration, and validation; international reporting; MedDRA version management; and safety data migration.
Sentrx is a leading provider of technology-enabled solutions and services for global drug safety. Its mission is to help pharmaceutical, biotechnology, medical device, and consumer health companies document the safety profile of their products during clinical development and post-approval, enabling them to minimize risks and maximize benefits. Through its multilingual Safety Response Center, Sentrx delivers a unique combination of highly skilled people, exclusive technology, and best practices in drug safety monitoring. To learn more about Sentrx, please visit the company's website at http://www.sentrx.com, or call 1-888-399-8032, extension 261.
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 250 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, or FDA, GlaxoSmithKline, Harvard Clinical Research Institute, Merck & Co., Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. 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 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 alliance partner, and its alliance partner's customers, and their ability 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 customer and alliance partner, and its alliance partner's customers, to realize benefits from the use of its products and services, changes in regulatory requirements applicable to Phase Forward's customer and alliance partner and its alliance partner's customers, the manner in which Phase Forward's customer and alliance partner and its alliance partner's customers conduct business and the possibility that their 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 Quarterly Report on Form 10-Q.
Gretchen Dock, 781-902-4413
CHEN PR, Inc.
Randy Wambold, 781-672-3119
Jill Notte, 1-888-399-8032, ext. 261
Posted: July 2007