An examination of Quintiles’ experiences in developing, refining, and implementing risk-based monitoring, and the role of such monitoring in data-driven trial execution. Lessons learned concerning the optimal number of thresholds for triggered monitoring; the need for not only precise initial articulation of these thresholds, but also their continuing rearticulation throughout a study; and the benefits of an automated approach that have proved extremely effective in refining our RBM strategy and its use within our data-driven trial execution capability.