Considering the ever-rising cost, scope and complexity of clinical development, life science companies, contract research organizations (CROs), regulatory agencies and industry organizations are striving to find cost-effective ways of conducting on-site monitoring as this is the most costly aspect of running clinical trials.
The most significant approach to emerge in the last decade for a more efficient, cost-saving way to improve clinical trial monitoring is risk-based monitoring (RBM). This approach has been widely encouraged by regulatory agencies and is gathering momentum in adoption by sponsors and CROs. Proponents of RBM projects believe that the investment in this approach will return an overall reduction in monitoring expense by 15 to 20 percent. This paper discusses RBM as a high-value use case that can be enhanced by a robust clinical data aggregation and analytics solution.