Statistical Design/AnalysisStatistical Design/Analysis

C-TASC PhD Statisticians have over three-quarters of a century of expertise in writing statistical design sections for protocols and statistical analysis plans for clinical trials and studies. We specialize in presenting easy to read graphical representations showing the advantage of proposed sample sizes, and the net benefit that can be achieved by increasing a sample size for a proposed study, or whether a study at a proposed sample size is substantially over-powered for the research objectives of interest. By presenting power information as a function of sample size, it becomes easy for a sponsor to work with C-TASC Statisticians to arrive at the correct sample size to achieve the sponsor’s research objectives with the minimum number of patients. This lowers the sponsors overall cost for conducting a study. Again, with over three-quarters of a century of expertise in writing statistical analysis plans, you can be sure that C-TASC PhD Statisticians will identify the most appropriate analysis for your study. We routinely use advanced statistical methodologies such as survival analysis, longitudinal data analysis, and case control designs. Most recently C-TASC staff were responsible for assisting FDA Statisticians in performing over 60,000 analyses within a 1-2 month period of time to assess the safety, toxicity and efficacy of an NDA submitted to the FDA for evaluation. As such, C-TASC Statisticians have a good grasp on the type of statistical analysis plan that will be necessary for any protocol being submitted to the FDA. Let us help you in the design and analysis of your next study.