New medications and medical procedures must undergo clinical trials before they can be certified by the FDA. The gathering and processing of trial data, as well as the general administration of the clinical process, can be both time-consuming and error-prone. Our goal is to reduce the time and administrative burden placed on researchers, freeing them for additional research, by providing them with a computerized method of tracking and reporting these data consistently. In this SBIR, Cambridge Computer Associates, Inc., and its research affiliate, BioSurface Technology, Inc. propose to develop a PC-based, user-friendly software system that allows individual researchers to customize CRF's collect data automatically (via telecommunications) from trials sites, and perform validity checking, statistical analysis, and reporting. Existing systems are expensive, often deviate from evolving industry standards, and provide incomplete solutions. The Phase I effort will define features and functions of the final system, identify appropriate existing software packages to integrate as components, specify new software, and prepare an initial prototype.
