Phase Forward Announces Business Process Optimization Workshops for InForm EDC Customers

April 11, 2005

Applied Clinical Trials

On-Site Workshops Enable Customers to Fully Realize the Benefits of Their EDC Investment

On-Site Workshops Enable Customers to Fully Realize the Benefits of Their EDC Investment

Waltham, MA -- April 11, 2005 -- Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today formally announced the availability of Business Process Optimization (BPO) workshops for its InForm electronic data capture (EDC) customers. The BPO workshops focus on the specific processes in the clinical trial lifecycle where optimal use of EDC is expected to have the greatest impact and provide the most value. As part of the newly available services, the company is also offering its customers a free introductory BPO session within a specific function of clinical operations: remote monitoring, discrepancy management, or on-site monitoring and source verification. By identifying areas where there are opportunities for process and organizational improvements, the workshops will better position InForm customers to realize the cost savings and significant time, efficiency, and quality gains of their EDC investment.

When asked to evaluate their experiences using EDC, some organizations have reported they are not realizing the full benefits of the technology. This is rarely, if ever, due to the EDC technology itself. Rather, it highlights the general resistance to changing processes established for the conduct of paper trials, now entrenched in the organization's mode of operation. When these paper-driven processes and standard operating procedures (SOPs) aren't re-evaluated and optimized, organizations often miss the opportunities afforded by EDC, such as the ability to accelerate and improve business and clinical decision-making with real-time data visibility, lower costs by reducing cycle times, and enhance the efficiency of site management and monitoring. Process redesign and optimization are essential to gaining the advantages of new technology.

Phase Forward's BPO workshops offer a practical approach to realizing the promise of EDC. Documented best practices, delivered by consultants with direct, hands-on industry experience, form the foundation for the workshops. Phase Forward staff work with customers to analyze their current operations, compare them to the baseline, identify areas where significant improvements can be attained, and develop deliverables tailored to their operating environment.

"By using our best practices gained from hundreds of trials in 90 different countries as a framework for our workshops, customers can see results much more quickly than with traditional BPO services," said Martin Young, vice president of services for Phase Forward. "Our workshops are completed in days, rather than the weeks or months typical with third-party consulting firms. We are very excited to offer our customers an efficient and cost-effective way to get the most out of their EDC investment."

Industry leading academic research and pharmaceutical organizations, such as Harvard Clinical Research Institute (HCRI) and Lilly, have already leveraged the BPO workshops. For HCRI, its investment in the InForm software marked its introduction to EDC. As such, the company looked to Phase Forward's proven expertise to provide the model for optimizing its trial lifecycle management processes.

"The workshops required us to sit down and really analyze not only our processes but our way of thinking about them. During the session, we explored the "ideal process." The environment promoted free-thinking, vision, and endless possibilities," said Sandra Clark, associate director of data management at HCRI. "Reviewing the best practices allowed us freedom from the hurdles we meet in our day-to-day activities. I cannot say enough about how important the workshops were for directing the necessary changes as well as receiving commitment from the very people responsible for implementing them."

A webcast, entitled "Harvard Clinical Maximizes EDC Investment by Optimizing Processes," will be held on April 20th, 2005 at 11:30 a.m. EDT. Registration for the free event is at www.phaseforward.com.

Phase Forward's basic BPO offering is a ten-day suite of workshops which target key study set-up and study conduct processes. Phase Forward will also work with customers to scope and define a customized BPO program based on their specific objectives and priorities. The free, one-day introductory workshop available to InForm customers will be conducted at the customer's location, in one of the following process areas:

  • Remote monitoring: Designing monitoring processes that leverage real-time data visibility for more proactive remote site and data management.
  • On-site monitoring and source verification: Designing processes to increase monitoring efficiency and make each site visit more productive.
  • Discrepancy management: Optimizing the use of automatic and manual queries to expedite availability of clean data for analysis and shorten cycle times.

"Our experience working with pharmaceutical, biotech, and medical device companies of all sizes has given us direct insight into the challenges that come with improving the efficiency and quality of clinical trial processes," continued Young. "Our new BPO offering is designed to help our customers make significant, measurable progress in meeting these goals."

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.

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