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Speed and quality to reward a great variety of your needs


The confidence in the speed and quality of our monitoring team derives from the extensive in-house training system and the streamlined system of monitoring support to achieve client satisfaction by an entire monitoring service.

Monitoring Service Major Tasks

Selection of Investigators
and Institutions
  • Feasibility Research
  • Examination of investigators and institutions
  • Agreement of protocol with investigators
Clinical Trial Notification
  • Support for submission of “Clinical Trial Notification”,
    “Notification of the Change, Termination, and Completion”
Request for Study Participation
  • Study participation request to institutions and investigators
  • Participation and assistance of explanation at the Institutional Review Board (IRB)
  • Contract
Preparation of Study Initiation
  • Study initiation visit
  • Supplementation of investigational products and materials
  • Monitoring visit for study monitoring and communication with investigators
  • Verification of compliance to GCP and Protocol
  • Management of study progression
  • Record on monitoring visit report
  • Gathering, provision and management of safety information
Direct Access to Source Documents
  • Verification of storage status of essential documents
  • Source document verification
  • Inspection and collection of case report form
Formalities for study completion
  • Submission (support) and obtaining of “Notification of Study Completion”

In General, mid sized CROs have a major issue to cover wide range of disease experiences by crossing the boarder, and to maintain and train the specialty as a CRO. CSIA-CRO, however, share the cultivated specialty within the 3 companies including IND submission to US-FDA to fulfill the customer satisfaction, also with additional information regarding the actual Asian clinical condition and environment from CSIA–SMO.