The Division has served as the Data Coordinating Center for several multi-centered pediatric Phase III trials, despite the paucity of these trials. It is well poised to have a quick start-up time to any pediatric clinical trial. The biostatistical support includes developing the analysis plan, determining the appropriate sample size, generating randomization tables, and assisting in case report form development. During the trial, the groups monitor and report adverse events and prepare interim analysis. At trial s end, they analyze the trial database, performing both simple and complex analyses and preparing survival curves and predictive models.
All work is performed using industry standard applications with appropriate validation procedures.