SOFTWARE FOR MULTICENTER TRIALS IN PSYCHOPHARMACOLOGY

THIS RESEARCH IS INTENDED TO RESULT IN THE DEVELOPMENT OF SOFTWARE FOR MICROCOMPUTERS TO PROVIDE ON-SITE, CLINICAL RESEARCH DATA MANAGEMENT, INCLUDING DATA COLLECTION, VERIFICATION, ANALYSIS, AND REPORTING AS WELL AS TRIAL MANAGEMENT AND MONITORING ACTIVITIES FOR SINGLE-PROTOCOL, MULTICENTER TRIALS IN PSYCHOPHARMACOLOGY. WE WILL EXPAND OUR CURRENTLY EXISTING CLINICAL RESEARCH SYSTEM TO IMPLEMENT A MICROCOMPUTER-BASED SYSTEM WHICH IS BOTH ECONOMICALLY FEASIBLE AND EASY TO USE BY HEALTH CARE PERSONNEL FOR SMALL-, MEDIUM-, AND LARGE-SCALE MULTICENTER CLINICAL TRIALS OF NEW PSYCHOPHARMACOLOGICAL TREATMENTS, PHARMACEUTICAL PRODUCTS, AND MEDICAL DEVICES. IN ADDITION, THIS PHASE I SYSTEM WILL BE EQUALLY APPLICABLE TO CLINICAL TRIALS INVOLVING MULTIPLE CENTERS, BUT NOT OF SINGLE PROTOCOL, MULTICENTER MODEL. THE PHASE II SYSTEM WILL ENABLE INTERNATIONAL MEDICAL PRODUCTS CORPORATION AND ITS DIVISION, CLINICAL RESEARCH SYSTEMS, INC. TO SUPPLY THE PHARMACEUTICAL INDUSTRY WITH A CLINICAL RESEARCH TOOL WHICH HAS THE POTENTIAL TO IMPROVE THE ACCURACY AND SPEED OF CLINICAL DATA COLLECTION FROM NATIONALLY AND INTERNATIONALLY BASED MULTICENTER CLINICAL TRIALS. THE PHASE II SYSTEM WILL HAVE THE CAPABILITY TO HANDLE EASILY MANY REMOTE SITES AND DRUGS AND PROTOCOLS CONCURRENTLY WHEN BEING USED IN CONJUNCTION WITH THE PHARMACEUTICAL MANUFACTURER'S MAINFRAME COMPUTER.