Phase Forward Introduces Version 7.2 of Empirica™ Signal Solution
January 21 2010 - 9:00AM
Business Wire
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.
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