Consumer Product Clinical Assessment (CPCA)

Prodia the CRO is the first full service CRO in Indonesia which provides full support to pharmaceutical,
biotech industries, and consumer product industries (especially in cosmetics and toiletries) to conduct
GCP clinical trials.

Main services offered by CPCA includes :

Product Efficacy Assessments 

Assessment of Product Efficacy including visual assessment by trained expert assessors, instrument measurements by trained operators and self perception questionnaires by trained personnel. CPCA has personnel and experts with GCP certificates who have been involved in the skin clinical trials for more than 20 years. Supported by the latest instruments and technology, and has served several companies in many countries.

A. Visual Assessment including :

  1. Tolerance evaluation:
    • HRIPT,
    • patch test, and
    • dermatological control of the tolerance
  2. Safety evaluation: erythema and dryness
  3. Efficacy evaluation:
    • Skin ligthening (face, arm , underarm)
    • Anti ageing
    • Anti Dark spot
    • Anti Dark Circle
    • Smoothness and Chicken Skin on Underarm
    • Moisturising (callouses/cracking/discoloration/dryness/roughness on heel and sole/ball and dryness/flaking/roughness on elbow and knee)
    • Pore on face
    • Acne on face by Dermatologist
    • Hair assessment
    • Consumer feedback

B. Instrumental Measurement including :

  1. Skin tension/skin elasticity/skin firmness
  2. Skin hydration
  3. Skin sebum
  4. Photography of Face, Arm, Underarm, Hair
  5. Skin color
  6. Skin texture

C. Self perception questionnaires according to study objectives and sponsor requests.

Consumer Product Clinical Assessment (CPCA)

Other services offered by CPCA includes :

  1. Protocol Clinical Study Development/Review
  2. Regulatory Approval: Ethical Approvals from independent Indonesian EC and or Material Transfer Agreement from MTA Agency
  3. Establish the site study master file
  4. Subjects Recruitment
  5. Obtain informed consent
  6. Medical history check
  7. Safety Monitoring, record and management of AE and SAE (if any)
  8. Study documents and CRF preparation
  9. Schedule subject visits
  10. Daily subject home visit to supervise/monitor product application
  11. Data Management including double data entry, data verification and data queries management, Archiving,
  12. Weekly updates and Final Report.
  13. Overall study administration and Quality Control
  14. Study Products Management including import license & Labeling