By Kristin Mauri, PMP, Global Head, Risk-Based Monitoring, Bioclinica
Risk-based monitoring (RBM) is finally starting to gain momentum as the standard for trial execution within the industry. In fact, a few of the Transcelerate companies are already working in a model where RBM is deployed across all trials, and RBM is also finally starting to take off with mid-size to small pharma. Before long, RBM will become the de facto standard for trial execution. Because on-site monitoring practices were the first to change in the move toward an RBM-based strategy, the initial impact has been absorbed by clinical operations teams. As companies become more sophisticated in their approach to RBM and recognize that RBM extends beyond just on-site monitoring to all types of data monitoring, there is a group of individuals who are critical to the process and cannot be left out of the conversations—your data managers, who ultimately are the steward of data quality and data integrity in a trial.