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InForm Integrated Trial Management Expands Electronic Data Capture to Incorporate Real-time, Trial Management Reporting and Analysis
Waltham, MA -- April 25, 2005 -- 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 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 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 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.