The Offeror plans to provide a Data and Analysis Coordinating Center for Phase I and Phase II AIDS Clinical Trials. The Offeror will be a central data collection and management resource. The Offeror will develop and implement statistical methods appropriate for a multicenter clinical trial. Response Surface Methodologies will be used to estimate confidence intervals of optimal responses and stationary point dosages, develop sample sizes, and consider related ridge regression relationships. The Offeror plans to develop the computer software needed to input the data at each Vaccine Evaluation Unit, a Manual of Procedures, study forms, report forms, technical manuals, etc. The Offeror also plans to train the personnel at each VEU to use this material. The data will be reviewed promptly for completeness, accuracy, consistency, out-of-range values, and overall quality. Laboratory data will also be reviewed for accuracy. The Offeror will provide for the design, development, implementation, and inventory control for a vaccine distribution system.
