Phase Forward (ticker: PFWD, exchange: NASDAQ Global Market (.O))
News Release -
25-Apr-2005
Phase Forward Announces New Release of Its Market-Leading Inform Electronic Data Capture Solution
WALTHAM, Mass.--(BUSINESS WIRE)--April 25, 2005--
-- InForm Integrated Trial Management Expands Electronic Data
Capture to Incorporate Real-time, Trial Management Reporting
and Analysis --
Phase Forward (NASDAQ: PFWD), a leading provider of data
management solutions for clinical trials and drug safety, today
announced that the newest release of its market-leading electronic
data capture (EDC) solution, InForm(TM) Integrated Trial Management
(ITM), will be available on May 3, 2005. The InForm ITM software
offers comprehensive, real-time trial management reporting and
analysis capabilities embedded directly into the product - no separate
user interface is required. The new release of InForm provides
clinical organizations with the ability to enhance the execution and
management of clinical trials, improve and accelerate clinical
decision-making, and realize increased cost savings.
Life sciences companies are under increasing pressure to improve
the efficiency and effectiveness of new product development and speed
introduction to the market. Mounting drug safety concerns, rising cost
pressures, and increasing failures of drug candidates in later
clinical trial phases are presenting these organizations with
significant clinical and business challenges. Streamlining the
clinical trial process to improve productivity and speed development
time through innovative technology solutions is quickly becoming a
mandate. Real-time access to operational trial information necessary
to proactively measure, monitor, and manage trials is now a key factor
to drive meaningful process change and performance improvements.
In the six years since introducing its Web-based EDC solution,
Phase Forward has, either directly or through contract research
organizations (CROs), successfully helped pharmaceutical,
biotechnology, and medical device companies of all sizes - over 750
trials in 90 countries around the world - realize the benefits of EDC.
Building on the core value of its existing product, the company's new
release of InForm offers unparalleled clinical and operational
reporting and analysis capabilities for integrated trial management
that can dramatically improve productivity in the clinical trial
lifecycle. Most importantly, the product enhancements provide clinical
organizations with real-time visibility into trial progress at any
site, anywhere in the world, at any time, in a format they can take
action on immediately. Clinical personnel can track and manage key
trial metrics on critical issues such as recruitment progress and
subject dropout rates, manage to performance targets, and drive
critical operational improvements by identifying and correcting
process problems and optimizing resources. In addition, critical
patient safety information is immediately accessible for monitoring
and review, and adverse events can be automatically transferred to
Phase Forward's Clintrace(TM) 4 safety system for prompt processing
and generation of regulatory reports.
Comprehensive Reporting and Analysis Capabilities
The InForm ITM solution, with its intuitive drag-and-drop
interface, provides a robust and flexible set of out-of-the-box
reporting and analysis tools, powered by industry-leading
ReportNet(TM) technology from Cognos. An extensive library of trial
reports, including 32 dynamic and fully configurable trial management
reports and 18 new reports specifically designed to assist monitors
with site management, are provided to help clinical staff track
metrics such as eCRF completion status, source verification progress,
and query cycle times. Flexible, personalized filtering and sort
settings turn trial data into 'actionable information' by directly
linking reports to the data capture or query management process,
providing users with a way to take immediate action on identified
issues. All clinical and operational data is housed in an open and
published database schema that can interface with third party
reporting tools and promote the standardization of reporting across an
organization's electronic clinical trials.
The InForm ITM software also has powerful ad hoc reporting tools,
enabling end-users to create and publish reports on-the-fly without
the need for extensive report customization or IT assistance. Unlike
competitive offerings that require additional software, strong
technical expertise, or custom report development from the EDC
solution vendor - which result in added costs and time delays - the
new release of the InForm solution puts reporting into the hands of
those directly responsible for running the study, the study teams.
Team members can further streamline trial management by creating
personal homepages with tailored views of data such as summary
snapshots covering a variety of trial metrics.
"With the new release of InForm, members of our trial design team
were able to create several reports within a few hours - a project
that previously would have taken days to code," said Rob Case, global
EDC development manager at Procter & Gamble Pharmaceuticals. "Initial
feedback from our clinical data managers and site monitors on the
reporting and analysis capabilities has been positive. We look forward
to continued use of the product and are eager to take advantage of the
wide range of new functionality."
Productivity Enhancements Across All Clinical Roles
For monitors, remote access to detailed and up-to-the-minute site
status allows for better visit planning to minimize travel and
maximize effectiveness while on site. A monitor can run reports on
data entry, query rates and response times, form completion, and
signature status, to plan for an upcoming site visit. These efficiency
gains allow monitors to work with more sites and support additional
trials, improving overall workflow and productivity in the clinical
process.
Data managers can use reports to identify bottlenecks in data
collection, query management, or data review. For example, a data
manager may observe a high incident of queries from multiple clinical
sites associated with a specific eCRF, indicating the need for trial
designers to review the eCRF for potential improvement.
Project managers also benefit from the new functionality with the
ability to better track and manage trial progress. With InForm ITM,
project managers are able to gain a real-time view of critical
clinical events, such as adverse events or protocol violations, and
can proactively monitor patient recruitment to identify slow
enrollment or high dropout levels or track and trigger payment
milestones. In addition, managers are better able to manage CROs and
other trial partners through direct access to externally collected
data.
"The InForm ITM solution leverages Phase Forward's experience
running hundreds of global trials. With InForm ITM's new reporting
capabilities, Phase Forward continues to drive operational efficiency
and streamline workflow in clinical trials," said Judy Hanover, senior
research analyst at Life Science Insights, an IDC Company and leading
research organization.
"The trial management capabilities of InForm ITM were designed
based on extensive feedback from our customers. Sixteen percent of our
revenues are invested in research and development to enhance our
products and meet customer requirements. We believe this represents a
larger investment - both as a percentage of revenues and in total
dollars - than any other EDC vendor in the market," said Steve
Rosenberg, vice president of development at Phase Forward. "The key
benefits of EDC - real-time visibility into data and the ability to
quickly and easily analyze, report, and take action on it - are now at
our customer's fingertips with InForm ITM."
About Phase Forward
Phase Forward is a leading provider of integrated data management
solutions for clinical trials and drug safety. The company helps
pharmaceutical, biotechnology, and medical device companies bring
needed drugs and therapies to market faster and more safely. Phase
Forward offers proven solutions in electronic data capture (EDC),
clinical data management (CDM), and adverse event reporting (AER).
Phase Forward products and services have been utilized in over 10,000
clinical trials involving more than 1,000,000 clinical trial study
participants at over 220 organizations worldwide including:
AstraZeneca, Biogen Idec, Boston Scientific, Dana-Farber Cancer
Institute, Eli Lilly, GlaxoSmithKline, Guidant, Procter & Gamble,
Quintiles, Sanofi-Aventis, Schering-Plough Research Institute, and
Serono. 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 of Phase Forward's products and services, future
business and operations plans of Phase Forward customers, and the
ability of Phase Forward's customers 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 customers to realize benefits from the use of its
products and services, and the possibility that customers' needs or
plans may change over time. 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
Annual Report on Form 10-K.
CONTACT: Phase Forward
Pam Sullivan, 781-902-4502
pam.sullivan@phaseforward.com
or
SHIFT Communications
Brian Gendron, 617-681-1226
bgendron@shiftcomm.com
SOURCE: Phase Forward
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