Can a risk-based monitoring (RBM) solution go beyond saving money and actually improve data quality and accelerate treatments to market? Medidata says, “Yes!”
On-site monitoring, especially source data verification (SDV), accounts for about 30% of the $7.5 billion spent annually on clinical trials. Two recent studies indicate that a 100% SDV approach results in changes to less than three percent of data , and the percentage of SDV queries that generated on critical data averaged only 2.4 percent. That means thousands of hours of monitoring time and more than $2 billion spent on 100% SDV has little impact on clinical trial data quality.