Quintiles launches new predictive and advanced analytics capabilities
Global CRO Quintiles has added advanced statistical monitoring and predictive analytics capabilities to its risk-based monitoring (RBM) solution. Predictive and Advanced Analytics combine Quintiles' experience in RBM with its therapeutic and statistical sciences heritage to enable study teams to identify the right signals and predict clinical trial site performance and potential patient safety issues.
Predictive and Advanced Analytics are the first such model-based capabilities fully integrated into an RBM solution on the market. Underpinned by the Quintiles Infosario technology platform and Quintiles' data resources, these new capabilities improve precision in risk identification by better understanding underlying "white noise" from safety trigger processes.
"The ultimate goal of risk-based monitoring is to increase the efficiency of drug development while improving quality and patient safety," said Margaret Keegan, senior vice president, Data Sciences & Strategy at Quintiles. "The ability to cut through all the noise and predict potential risks before they occur means we can target the right action at the right place at the right time. It is a major step forward in improving quality and productivity in the next generation of RBM execution."
Compliant with FDA, EMA and TransCelerate guidance, Predictive and Advanced Analytics use unique statistical algorithms specifically designed for optimal RBM execution. The capabilities combine inputs across multiple variables including operational performance and study data to provide unprecedented insights into potential study risks.