 | | | | | | 
 Building up investigators database
Site selection and evaluation | | | | | |
| | | | | | 
Site visits
 Initiation
Monitoring
Close out
Emergency
Site personnel guidance
Review of subjects eligibility
Compliance with Protocol and ICH/GCP
Pre visit letters, monitoring reports and follow up visit letters
Ensuring duly AE/SAE reporting | | | | | |
| | | | | | 
Data entry
Data cleaning
Query management | | | | | |
| | | | | | | 
Site recruitment
Pre study visits
Regulatory procedures
Protocol requirements review
Review of all necessary documents for approval procedure
Application for Clinical trial approval
Application for Ethics approval of clinical study
Patients insurance
Submission of annual and final reports
Communication with regulatory authorities during all study duration | | | | | |
| | | | | | 
Documentation and reports review
Negotiation process including budget planning and payment control
Investigation meeting preparation and project team meeting
Personal training and co-monitoring
SAE reporting coordination | | | | | |
| | | | | | 
Medical writing
Translation and back translation of all related to clinical trials documentation | | | | | |
| | | | | | 
Import/export licenses obtain
Customs brokerage
IP and Clinical supplies warehousing
-20°C
+2+8°C
Ambient temperature
IP and clinical supplies distribution
Acceptance
Selection
Dispatch
Reporting
Transportation to and from clinical sites
Relabelling
Destruction
Accountability | | | | | |
|
