We apply different strategies to conduct monitoring: In addition to the regular visits of sites (“on-site monitoring”), our team ensures the supervision of the sites by telephone monitoring (so-called “remote monitoring”). Furthermore, we make us of the method of “centralized monitoring”. This is a monitoring system in which the data can be checked for inconsistencies over several sites. As monitoring activities are one of the major cost drivers of clinical trials, in recent years, a new approach has been developed with the “Risk Monitoring” which aims to use the resources for the monitoring more efficiently: Instead of carrying out 100% SDV, the monitoring focuses on those data, which are critical for the clinical trial – “laser instead of floodlight”.
The intensity of the monitoring activities is subject to a preliminary risk analysis, a systematic and technically complex method for the determination of risky areas within a clinical study. We specifically target our limited monitoring capacity at such areas. This risk-oriented quality management approach is also supported by regulators.