Phase Forward (NASDAQ: PFWD), a leading provider of data solutions for
clinical trials and drug safety, today announced the availability of
version 7.2 of its Empirica™ Signal product, a significant new release
of the company’s flagship signal detection and management software. The
Empirica Signal solution is a state-of-the-art data mining and knowledge
management tool and a cornerstone component of Phase Forward’s Empirica
Suite of pharmacovigilance and risk management products.
New features in the Empirica Signal 7.2 solution center on the Topic
Tracker module, which was introduced with Empirica Signal 7.0. This
module allows safety experts to create records of signals and other
topics of interest, including those identified outside the Empirica
Signal environment. Users can collect supporting analyses and
documentation using configurable signal management workflow capabilities
to direct responses.
New Topic Tracker features include added support for Topic actions,
linked Topics, additional permissions and administration options for
managing workflow configurations, expanded customization options,
enhanced quick filters and searching, and new management reports on
Topic information.
"Our experience with the new Topic Tracker has added strategic value to
our processes and we are looking forward to the benefits it provides,”
said Fred Schneiweiss, associate director medical safety, Alcon
Laboratories, Inc. "Topic Tracker, coupled with the many powerful
features of Empirica Signal for signal detection, has enabled us to
increase our ability to proactively manage the safety of our products in
a controlled, compliant manner throughout the full product lifecycle.”
"Empirica Signal 7.2 was specifically designed in response to requests
from key clients to provide a more comprehensive management system for
tracking and managing safety-related topics of all types for a broader
user community – not just those that arise from data mining spontaneous
report databases,” said Chan Russell, president, Phase Forward’s Lincoln
Safety Group. "With this release, we believe we are empowering customers
to establish a more comprehensive safety management environment that
will significantly expand their ability to meet the increased regulatory
and safety challenges facing today’s pharmaceutical industry.”
The Empirica Suite of Products
The Empirica Suite is Phase Forward’s complete solution set for
pharmacovigilance and risk management. In addition to Empirica Signal,
the suite includes Empirica Trace for adverse event data management and
reporting, the companion Empirica Gateway product for submission and
receipt of data in E2B standard format, and Empirica Study, for signal
detection of clinical trials data.
Phase Forward’s safety products are used by regulatory authorities,
biopharmas, medical device manufacturers and contract research
organizations (CROs) of all sizes to implement proactive strategic
pharmacovigilance programs. The product family name, Empirica, signifies
the importance of empirical data in the decision-making process.
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, sanofi-aventis, Schering-Plough Research
Institute, Servier, SGS, 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 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 regulatory agencies. 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, 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.