The length and complexity of the clinical trials required for investigatory products place a significant burden on the health care community and public. Computer support is an obvious solution to many of the associated problems, but is not always available for each kind of trial and to all trial sponsors. The goal of the proposed project is a computer based clinical trials system software product that: 1) can be customized by the user for a variety of clinical trials and investigational products: pharmaceuticals and biologics, and, 2) will be marketed in affordable modules that function singularly and together on a variety of computers and computer networks. The specific goal of Phase 1 is to demonstrate the feasibility of the primary research objectives, i.e. user customization and modularity. A systematic methodology and prototyping will be used to provide the technical assessment. In Phase 2, an evolutionary methodology and object oriented techniques will be used to develop the system modules. Additional objectives are a software product with an intuitive, """"""""user friendly"""""""" interface, stable operation, growth capabilities, and one that can be easily validated, an important feature for clinical trial support systems.
