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Risk has always been front and center in clinical trials. Risk-based thinking not so much. The desire to err on the side of caution leads many companies to distribute their risk management efforts evenly across sites instead of focusing those efforts where they are most needed. Instead of taking the same approach across the board, regulators are encouraging pharmaceutical companies to look at where the biggest risks to data, quality, patient safety, and trial integrity are, and focus most of their efforts on that.