Icon launches risk-based monitoring service
Global CRO Icon has launched ICONIK Monitoring, the first in a series of new services that will leverage its ICONIK technology platform.
ICONIK Monitoring enables the targeted use of monitoring resources by using scientific analysis of real-time data, together with CRA site knowledge, to direct central and on-site monitoring activities based on need. It uses event, data volume and risk-based triggers to ensure effective use of monitoring resources. It is designed to meet regulatory and quality requirements for GCP and is consistent with the guidance documents published by the FDA and EMA on risk-based monitoring, and with the TransCelerate Risk Based Monitoring Methodology.
Icon continuously refines the metrics selected for surveillance using ICONIK monitoring and the algorithms used to calculate those metrics. These settings and the pre-programmed methodologies for combing databases and comparing data points can be adapted to suit the study protocol and therapeutic area.
“ICONIK Monitoring enables us to rapidly identify and resolve site-related issues and achieve a higher level of process and data consistency across sites,” said Dr. Nuala Murphy, executive vice president, global clinical and data operations, Icon Clinical Research. “By ensuring more effective use of site visits, ICONIK Monitoring can also reduce study costs and in some large studies these savings can be as high as 15% to 25% of the overall cost of the study.”