Clinical Operations

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.
Pre-Study Site Visit Investigator Meeting
Site Initiation Visit IRB Activities (In-study IRB Support)
Monitoring Visit (Centralized & On-site) Safety Management
Query Resolution Regular QC / For Case QC
Close-Out Visit In-house QC/ On-site QC
Document Management MFDS Inspection Support
Site Staff Training  
Experience
Experience

Study Types

243 Projects

Therapeutic Area

243 Projects
[Updated on June 2017]