Before being put on the global market, products, according to the regulations of their sector, shall generally be tested to be safe for human health, if used under normal or reasonably foreseeable conditions. After having performed the toxicological evaluation and preliminary in vitro studies, it is possible to check the product tolerability through studies which involve human beings, with the aim of protecting companies and consumers.
In order to achieve this goal, at CDC Dermo-Clinical Research Institute and other external medical studies, we perform specific safety tests on volunteers, enrolled according to specific inclusion and exclusion criteria. The aim of the tests is to clinically evaluate the irritation, sensitization, tolerability of the products and the occurrence of undesirable effects, under the supervision of specialized medical staff. Tests are performed by using CE-labelled non-invasive instruments and medical devices. They are conducting in compliance with any current regulation and recognized EU and international guidelines. Studies on skin irritation (human cutirection) of medical devices are conducted according to the provisions of the UNI EN ISO 10993-10 standard.
Bio Basic Europe guarantees to meet the ethical principles of the Biomedical Research, as described in the World Medical Association Declaration of Helsinki, regarding the correct execution of clinical studies on human beings.