CSIA Services
Monitoring
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
and Institutions
- Feasibility Research
- Examination of investigators and institutions
- Agreement of protocol with investigators
- Support for submission of “Clinical Trial Notification”,
“Notification of the Change, Termination, and Completion”
- Study participation request to institutions and investigators
- Participation and assistance of explanation at the Institutional Review Board (IRB)
- Contract
- 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
- Verification of storage status of essential documents
- Source document verification
- Inspection and collection of case report form
- 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.