Historically, industry clinical trial best practices for monitoring required 100% source data verification (SDV), with monitors dispatched to visit each investigation site for regular evaluation of data and processes that impact protocol compliance.
This will not only eliminate the need to manually transcribe patient data into an EDC system which can be days or weeks after the patient visit but will also cut costly and time-consuming onsite source data verification by clinical monitors.
Policy changes are also already happening in pharma with more companies making a switch to risk-based management (RBM) from the less efficient process of source data verification, just one way were seeing reactions to outdated processes and an attempt to modernize the industry.
RBM offers an error rate four times lower than other practices, alongside 30% reduction in source data verification. RBM, therefore, is clearly an improvement over traditional review methods, said Jagadeesh Rudraswamymath of Quintiles.