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RBM Implementation - Top 3 Areas to Simplify

Steve Young: Sep 14, 2015 1:53:00 PM

Risk-based monitoring (RBM) presents a tremendous opportunity for the life sciences industry. The FDA and the EMA have both issued very strong endorsements for RBM through their guidance documents issued over the past couple of years, clearly signaling to the industry that this paradigm represents a superior approach to achieving quality in the conduct of clinical research. And RBM also presents a tremendous opportunity in terms of resource efficiencies, particularly in the area of site monitoring. The following graph comes from an RBM value calculator developed at OmniComm, and illustrates the significant value that can be realized for a typical phase 3 study – value derived not just from resource efficiency gains but from improved quality as well.