In light of over 20 years of experience, SPINCONTROL is specialized also in clinical studies for pharmaceutical products.
Spincontrol Group can design the relevant protocol which takes into consideration regulation requirements’ criteria for the evaluation of applications for the authorization of beauty claims on foods, medical devices, borderline products and dermocosmetics.
- Specific procedures for human intervention studies (adequate control group, full randomization, treatment allocation concealed, sample size calculation, ...)
- Relevance of inclusion/ non inclusion criteria for the study population in view of the target population for which the claim is intended
- Relevance of the main criteria of efficacy in view of the wording of the target claim
- Adequacy of the technical protocol in view of the recommended conditions of use and the claimed effect
- Quality Assurance System (QAS) congruent Good Clinical Practice (GCP) and ICHE6 requirements
- Authorisation to conduct biomedical research on foodstuffs, medical device and borderline products
- An internal team of experimented investigator : ophthalmologist and dermatologists
- Regulatory monitoring and scientific according to international requirements
- More than 30,000 volunteers documented on more than 300 different items (age, skin type, cosmetic habits etc.)
Techniques and claims
Our clinical studies can be performed according to different protocols Technical approach This approach is based on the use of instrumentations which allow quantitative and/or illustrative results (3D technologies (AEVA system (Eotech), image analysis, Infra-red camera, Dynaskin and all the other [...]