Other than the 3 main services previously mentioned, CPCA also has other services to support the smoothness and success of consumer product clinical trials.
The Scope of work offered by CPCA including:
Protocol Development/Review
ICF Development/Review/Adaptation/Translation
CRF Development/Review/Translation
Provide Principal Investigator and or Sub-Investigator
Regulatory Approval: Ethical Approvals from Independent Indonesian EC, Material Transfer Agreement from MTA Agency, or Import License for Study Product (IP) from BPOM
Establish the Study Master File (Site Master File)
Subjects Management: recruitment, home monitoring for product application, set up subject visit schedule, subject indemnification
Study Product (IP) Management
Obtain Informed Consent
Medical History Check
Safety Monitoring, record and management of AE and SAE (if any)
Data Management including double data entry, data validation and data queries management
Weekly updates (or as requested by Sponsor) and Final Report.
