eSource and Risk-Based Monitoring

The growing cost of drug development paves the way for newer technologies in clinical research. Taking its cue from success stories of automation across industries, the pharmaceutical sector’s acceptance of the Cloud, Big Data, and analytics stands as a testimony to changing times. Risk-based monitoring (RBM) looks at study issues at the root level and uses technology to challenge the status quo. The need for 100% source data verification (SDV) is being challenged, and innovative ideas to reduce SDV are being explored. Electronic source (eSource) can catalyze clinical trials transformation via RBM.