A GLOBAL, INTEGRATED, MODULAR CLINICAL TRIAL SYSTEM

THE LENGTH AND COMPLEXITY OF THE CLINICAL TRIALS REQUIRED FOR INVESTIGATORY PRODUCTS PLACE A SIGNIFICANT BURDEN ON THEHEALTH 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 TRIALSPONSORS. THE OVERALL GOAL OF THE PROJECT IS A COMPUTER-BASED CLINICALTRIALS 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 FUNCTIONSINGULARLY AND TOGETHER ON A VARIETY OF COMPUTERS AND COMPUTER NETWORKS. THE SPECIFIC GOAL OF PHASE I 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 II, 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.