Our Services and Methodology
Our statisticians develop statistical analysis plans, which reflect study goals and closely follow the ICH guidelines for the design of case report forms (CRFs), database structure, data plausibility checks, and quality control procedures as well as choice of study objectives, sample size calculation, inclusion/exclusion criteria, study endpoints, randomization, sample size and power, safety monitoring, and interim and final analysis of data. We produce final datasets directly from the electronic data capture database; this includes all relevant metadata and the accompanying final dataset documentation.
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