A critical failure of conventional clinical trial technology is that it does not adequately address strict new regulatory requirements, the increasingly distributed and community based nature of clinical trials and their increasing number, cost and complexity. An innovative, secure, Internet based technology is proposed that does. Strong preliminary results support the Phase I objective of using this technology to replace an existing cancer protocol management system. The capabilities of this replacement will include protocol tracking, protocol management, patient registration and basic monitoring of study specific data; all web accessible throughout a distributed organization. The primary innovation is a focus on standard processes rather than data standards. These processes mirror interactions within a distributed, modular organization. A proposed incremental development strategy, minimizes risk, takes advantage of proven technology, and distributes costs over time. The Phase II goal will be development of more capable technology that can be configured to meet the specialized requirements of any cancer center. An incremental commercialization strategy begins with cancer centers, then organizations pursuing cancer related research, and later pharmaceutical, biotechnology and medical device research. SBIR funding is critical because, unlike the later markets, cancer centers represent a small, cost sensitive market unlikely to attract private investment.
