Remote source data verification (rSDV) is where the verification of source data is done remotely, off-site via a centralized location and by a specialist team. It is possible for multiple site’s source data to be checked at a single centralization location instead of going to a particular site. This introduces us to the concept of centralized monitoring.
When centralized monitoring and an rSDV approach is considered, the focus is usually on certain sites such as; high recruiting sites, low compliance sites, and sites with predicted or previous protocol deviations/violations. Also it is common for centralized monitoring and rSDV to focus on data points related to primary end points, safety data and certain trial related processes.
Our rSDV platform is also an enabling technology for companies to successfully introduce Risk Based Quality Management (RBQM) – and help to target monitoring toward higher risk sites, resulting in more effective use of on-site monitoring resources. As source data is verified (both traditionally and remotely), this creates input data for other software solutions for our statisticians and data scientists to detect outliers, anomalous or fraudulent data defined both within a monitoring plan inclusive of key risk identification (KRIs) and in additional issues that lie outside the defined KRIs.