Duke standardizes on Phase Forward's InForm EDC solution for clinical trials worldwide

The DCRI will use the InForm electronic data capture (EDC) solution, in conjunction with Phase Forward's Clintrial and Clintrace applications, as part of an integrated clinical trial environment t

By Editor on Mar 30, 2004

The DCRI will use the InForm electronic data capture (EDC) solution, in conjunction with Phase Forward's Clintrial and Clintrace 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 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, CEO 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."