The iTrials Protocol Simulator™ is a protocol feasibility and optimization tool designed to identify the impact of each inclusion and exclusion criterion on the overall eligible patient population. iTrials conducts a rigorous analysis of the client’s inclusion/exclusion criteria and other components of the protocol design. After matching requirements to searchable criteria, iTrials compares the sponsor’s proposed trial design against the iTrials Data Universe to determine likelihood and probabilities of successful trial recruitment. Variations of the inclusion and exclusion criteria can be compared to measure impact on patient populations and optimize study design to enable productive enrollment targets. Predictive analyses identify timing and critical success factors. Also available is an online version of iTrials Protocol Simulator™ which allows sponsors and CROs to assess patient populations against protocol criteria in real time.