Clinical Operations

大事化小小事化无

“A clever person turns great troubles into little ones, and little ones into none at all.”

– Cao Xueqin

Clinical Operations is our “bread and butter,” our core service solution. Local Project Management and Clinical Monitoring were the first services we provided when we established CSC back in 2008 and have been the foundation on which our reputation was built. We take pride in our attention to quality and cost effective coverage – covering all the clinical trial hotspots in China. We are constantly examining the best ways to conduct clinical trials to facilitate rapid study start, ensure proper trial oversight, maintain quality outcomes, and achieve trial timelines.

How we can help:

1. 1. Feasibility Assessments
      • Study Feasibility Assessment
      • Site/Investigator Identification
      • Site Feasibility Assessment & Qualification

1. 1. Clinical Strategy & Planning
      • Study Planning & Execution
      • Risk Identification & Management

1. 1. Project Management
      • Project Oversight and Management
      • Project Team Coordination and Communication
      • Study Training
      • GCP Training
      • Periodic Status Reports
      • Third Party Management
      • Quality Control
      • TMF and/or e-TMF Development & Management

1. 1. Clinical Monitoring – Site Initiation to Site Close-out
      • EC/IRB Submissions
      • HGRAC Submissions
      • Site Initiation
      • Investigator Meeting Planning and Execution
      • IP Management
      • Supply Management
      • SMF Development & Management
      • SAE Management
      • Query Resolution
      • Site Close-out