Embedded Files
Clinical Trial Service List:
Local sponsor for clinical trial in Thailand
Protocol writing and development
Study document translation/ proofreading Eng to Thai
Feasibility study/ site networking and guidance on site selection and operational compliance
Site budget preparation and site payment management
Study document checking before archiving
Lab supply sourcing for clinical trial
Local sponsor for clinical trial in Thailand
Local sponsor for clinical trial in Thailand
CT-1 Application for Thai FDA
Reporting to Thai FDA
Cooperation with drug importer (LoR vendor)
Protocol Writing & Development
Protocol Writing & Development
Full Protocol Development
Protocol Review & Gap Analysis
Protocol Localization in Thailand
Study document translation/ proofreading English to Thai
Study document translation/ proofreading English to Thai
Study protocol / protocol synopsis
Informed consent form
Related study documents for patient in the study
Feasibility study/ site networking and guidance on site selection and operational compliance
Feasibility study/ site networking and guidance on site selection and operational compliance
Perform feasibility study
Collect information about study facility at potential clinical sites to sponsor
Connect with potential investigators to evaluate feasibility at potential clinical sites on behalf of sponsor
Site budget preparation and site payment management
Site budget preparation and site payment management
Prepare and negotiate site budgeting for clinical trial agreement (CTA)
Monitor site payment according to workload, recruitment, milestone, etc.
Study document checking before archiving
Study document checking before archiving
Check study document according to study TMF index
Contact with vendor for archiving study document
Manage study document shipment
Lab supply sourcing for clinical trial
Lab supply sourcing for clinical trial
Sourcing general lab supplies or special lab supplies
Lab kit importation applications with Thai FDA
Our focus areas in Thailand
Investigational Products:
Infectious diseases
Cancers
Metabolic diseases
Rare diseases
Dermatology
Gastroenterology
Medical devices
Diagnostic product validation
Human sample collection for research purposes
Clinical research regulations in Thailand
EC/ IRB submission: Central or local EC/ IRB
Thai FDA submission: CT-1 application
Clinical sites in Thailand
17 Academic Hospitals
General Hospitals
Institutions such as cancer Institutes, Thalassemia Centre, Diabetes Centre, etc.
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