24.07.2007 13:43:00
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Phase Forward and Sentrx Partner to Offer Integrated Drug Safety Services
Phase Forward (NASDAQ: PFWD), a leading provider of data management
solutions for clinical trials and product safety, and Sentrx, a leading
provider of technology-enabled services for global drug safety, today
announced a partnership that will provide life sciences companies with a
sophisticated combination of safety data management and adverse event
reporting software, processes and consulting expertise.
Sentrx will offer Phase Forward’s Clintrace™,
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.
About Sentrx
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™),
clinical data management (Clintrial™),
clinical trials signal detection (CTSD™),
strategic pharmacovigilance (WebVDME™ and
Signal Management), adverse event reporting (Clintrace™)
and applied data standards (WebSDM™). 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.
Cautionary Statement
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.
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