Clinical Operation

Clinical Operation

LSK Global PS performs the tasks of overall site management including the per-study visit, initiation visit, regular monitoring, and close-out visit. Through the monitoring, LSK Global PS ensures as the top priority the clinical study is properly conducted in compliance with the relevant regulations, SOPs, and protocol, and performs periodic quality control to increase the completeness and accuracy of the collected data.

Outstanding professional Manpower and systematic Organization of Personnel Resources

The personnel resources consisting of the managers and certified CRAs with wide experiences in clinical studies and the sufficient supporting staff (project support specialists, in-house CRAs) is a good stepping stone for conducting clinical studies successfully. In addition, the CRA line manager who is fully in charge of the CRAs’ performance is carrying out intensive personnel management including the evaluation on the CRAs’ performance of making progress in the study and the training for CRAs.

Dedicated Program

Based on the contracted projects, LSK Global PS offers centralized management of the projects utilizing its dedicated resources.

Efficient Clinical Trial Management System

LSK Global PS is managing the projects by introducing the CTMS(Clinical Trial Management System) for the efficient management of clinical studies. LSK Global PS is also conducting a variety of monitoring activities such as the centralized monitoring and risk-based monitoring as well as the on-site monitoring, and manages clinical studies by selecting the most appropriate way of monitoring them.

Process

Service Scope

Pre-Study Site Visit(PSSV)

Site staff training

Site Initiation Visit(SIV)

Investigator meeting

Site monitoring visit

IRB Activities (In-study IRB Support)

Centralized monitoring

Safety management

Risk-based monitoring

Regular QC / Case QC

Query resolution

Co-monitoring

Close-Out Visit(COV)

Inspection support

Essential document management

Experience

Study Types

120100806040200 Phase I Phase II Phase III Phase IV IIT Others

Therapeutic Area

327 Projects (Updated on 2019.12.31) Oncology Cardiovascular Neurology Ophthalmology Endocrinology Orthopedics Gastroenterology Hepatology Respiratory Vaccine Others