Extensive on-site review of clinical trial data has proven to be time consuming, expensive, limited in scope and prone to error. And unfortunately, some of the expense is passed onto the patient in the cost of the drug.
Risk-based monitoring can alleviate some of these costs and improve the quality of the data through use of a central computerized review of clinical trial data and site metrics. It can also help to determine if sites need more extensive quality review through actual on-site monitoring visits.
This paper demonstrates how a clinical trial team reviewed data remotely to protect the well-being of patients and ensure the integrity of final study results. It also discusses the tools used for identifying potentially fraudulent data at clinical sites.