C-TASC staff have been involved in numerous Phase III clinical trials for study treatments. Most recently we have completed the BABY HUG clinical trial, which seeks to determine whether administration of Hydroxyurea (an anti-cancer treatment) is effective in preventing organ failure in infants with Sickle Cell Anemia. C-TASC staff managed the IND for this trial and are actively involved in the current NDA submission. C-TASC staff were responsible for developing the overall study protocol, writing the statistical analysis plan, monitoring the study for performance, quality of data, safety, toxicity and efficacy. In addition, they managed the manufacturer of Hydroxyurea for young infants, monitored GLP activities for developing Hydroxyurea assays in infants/plasma, and the FDA annual reports.