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.
Product claims can be proven by consumer perceptions, based on the use of test products. The format of Subject Self-Assessment is adjusted to the Study Objectives and Sponsor Requests.
Assessment includes consumer evaluation of the benefits of using the product, the effects they feel, and product acceptance. In addition, data related to product features can also be obtained compared to other similar products that have been used by consumers. Collecting data may with qualitative or quantitative methods, it can be done with a questionnaire or an interview by trained personnel.
We can support the assessment of safety and efficacy of your product through a visual assessment. At CPCA, visual assessments are performed by trained expert assessors that have been involved in the skin clinical trials more than 20 years, and supervised by an experienced dermatologist whom expert on related field.
Visual Assessment including:
A. Safety and Tolerance evaluation :
B. Efficacy Evaluation :
Skin Ligthening (face, arm, underarm, leg)
Skin Moisturising
Skin Evenness and Radiance
Shiny/Oily Skin
Anti Aging
Anti Dark Spot
Anti Melasma
Anti Under Eye Dark Circle
Pore on Face
Acne on Face by Dermatologist
Smoothness and Chicken Skin on Underarm
Dryness on Elbow and Knee
Dryness, Callouses, Cracking on Heel and Sole/ball