We do perform overall site management functions, including pre-study site visit, regular monitoring, close-out visit, etc.
Our top priority is to ensure, by means of monitoring, that the clinical study is properly implemented in compliance with applicable regulations, protocol and SOP. Collected data are Quality-Controlled to improve their completeness and accuracy.
Recent increases in large-scale clinical trials have necessitated more effective management of trials and, for effective management, we introduced computerized systems including EDC system and Clinical Trials Management System (CTMS) and introduced Centralized Monitoring and Risk Based Monitoring in addition to On-site monitoring.
Besides the operational functions performed by Clinical Operation Team, QC/OM team takes the responsibility of site management and continuously oversees the study over the course of the study to improve the quality.