Duke Standardizes on Phase Forward's InForm EDC Solution for Clinical Trials Worldwide.

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WALTHAM, Mass.--(BUSINESS WIRE)--March 15, 2004

World's Largest Academic Clinical Research Organization Utilizes Phase Forward's Integrated Suite of Products for Clinical Data Management

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, today announced a multiyear collaboration with the Duke Clinical Research Institute. Building on a longstanding relationship with Phase Forward, the DCRI will use the InForm(TM) electronic data capture (EDC) solution, in conjunction with Phase Forward's Clintrial(TM) and Clintrace(R) applications, as part of an integrated clinical trial environment to increase the efficiencies of its clinical trials process and gain the flexibility and scalability critical to managing the DCRI's full continuum of clinical trials including large, global, multi-center trials.

Part of the Duke University Medical Center, the DCRI is the world's largest academic research organization (ARO), with more than 800 faculty and staff. The DCRI has conducted more than 100 clinical trials, enrolling 300,000 patients at 3,120 sites in 60 countries. Though best known for its work in the conduct of cardiovascular trials, the DCRI conducts Phase I - IV studies in more than 20 therapeutic areas and has more than 110 trials currently ongoing.

A customer since 1997, the DCRI has been using Phase Forward's industry-leading Clintrial and Clintrace applications for clinical data management (CDM) and safety tracking and reporting. Once the InForm solution is deployed at the DCRI, the integration with the Clintrial system is intended to deliver a single, powerful data management environment to handle collection, consolidation, analysis, reporting, and preparation for submission and archiving.

"The DCRI model is unique in that it combines the clinical expertise and academic leadership of a teaching hospital with the full-service operational capabilities of a large contract research organization," said Robert M. Califf, MD, director of the DCRI. "We decided to ally with to Phase Forward because we saw the potential to improve the efficiency in the way clinical research is done. In discussing the future with the leadership of Phase Forward, we agreed that huge amounts of money are wasted in today's clinical research environment because processes that could be automated and simplified continue to be done in outmoded ways. We are interested in electronic trial management, and electronic data capture is only a part of the overall strategy. Ultimately, this is one step along the way to full-fledged electronic medical records with common nomenclature and data standards: that's the prize we have in mind eventually."

In the immediate term, the DCRI will leverage Phase Forward's hosting services to perform electronic data capture for its clinical trials. Simultaneously, Phase Forward's Technology Transfer team and the DCRI will begin global technology and methodology planning, including implementation, system validation, and training for enterprise deployment of the InForm solution. Phase Forward will work with the DCRI to develop novel methods of organizing and managing the multiple tasks that must be accomplished in clinical trials.

"Our mission at the DCRI is to develop and share knowledge throughout the global medical community that improves the care of patients around the world," said Califf. "We are striving to impart our lessons learned and educate future generations of clinical researchers. We plan to do this through our clinical research 'networks' - infrastructures for sharing data within organizations and across enterprises to provide scientific leadership in the conduct of clinical trials. Phase Forward has made significant progress in developing technology that can support an integrated clinical trial environment and is well qualified to help us execute this vision."

"In executing a progressive technology strategy to achieve unparalleled operational efficiency and excellence in clinical trials, the leadership at the DCRI continues to position the Institute as a driving force in helping bring life-saving research and treatments to the global medical community," said Robert Weiler, chief executive officer and president of Phase Forward. "This innovator's commitment to Phase Forward speaks to our ability to serve as a long-term partner, our proven expertise, and the advantages our integrated clinical trial solutions provide in advancing clinical research."

About Phase Forward

Phase Forward is a leading provider of integrated enterprise-level software products, services, and hosted solutions for use in the mission-critical clinical trial component of its customers' global research and development initiatives. Phase Forward's customers include pharmaceutical, biotechnology, and medical device companies, as well as academic institutions, clinical research organizations, and other entities engaged in clinical trials. By automating essential elements of the clinical trial process, the company believes its products allow its customers to accelerate the market introduction of new medical therapies and corresponding revenue, reduce overall research and development expenditures, enhance existing data quality control efforts, and reduce clinical and economic risk. Phase Forward believes its enterprise software and hosted solutions are the most widely adopted commercial data capture, data management, and adverse event reporting solutions in the clinical trial marketplace, having been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants and 300 therapeutic compounds and medical devices. Phase Forward's customer base of over 220 customers is comprised of the leading pharmaceutical, biotechnology, medical device, and clinical research organizations, including AstraZeneca Pharmaceuticals LP, Corixa Corporation, Guidant Corporation, Eli Lilly and Company, Mayo Clinic College of Medicine, Novartis AG, and Schering-Plough Research Institute. Phase Forward is headquartered in Waltham, Massachusetts with offices in the United Kingdom, Australia, France, and Japan. Additional information about Phase Forward is available at www.phaseforward.com.