Implementing Risk-Based Monitoring in Rare Disease Trials
Risk-Based Monitoring (RBM) has become a cornerstone of modern clinical trial management, replacing traditional 100% on-site Source Data Verification (SDV) with a more strategic, data-driven approach. For rare disease studies—where patient populations are small, trial budgets are constrained, and geographic dispersion is common—RBM offers a particularly valuable set of tools.
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