What real-time data and Risk-based monitoring mean for your CRO
A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data.
RBM methods used by a central clinical trial monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from patients, devices and investigators reduces the relevance and efficacy of remote monitoring.
Real-time data is a sine-que-non for RBM.
Sponsors and Contract research organizations (CROs) should therefore approach real-time data and risk-based monitoring (RBM) as 2 closely related priorities for executing clinical trials. Use of modern data technologies for real-time data collection and remote risk-based monitoring will reduce non-value added rework, people and paper in clinical trials and help speed up time to statistical report.