Clinical trials regarding the tolerability and effectiveness of medicinal products, medical devices and cosmetics
Be it the exclusion of an irritative or allergenic potential, proof of bioequivalence, or an efficacy investigation – we are available to you as an experienced and competent full-service partner with internationally recognized study protocols which cover the requirements of European and US regulatory authorities, to carry out GCP-compliant clinical trials as well as trials subject to regulatory approval. We conduct these in compliance with the relevant statutory requirements, guidelines and standards for dermatological, allergological, ophthalmic and dental medicinal products, as well as for medical devices. As a rule, we carry out your testing assignment as part of a monocentric study at our main site in Schenefeld near Hamburg. If necessary, we can also offer you a multi-center trial based on our network of qualified test centers.
In Dermatology, Oral Care, Ophthalmology, Hair Care, Women’s Health and Sun Care
We serve the need for scientific evidence and claims support studies with a variety of established study protocols, specified either by guidelines such as those issued by the FDA, Colipa, or ISO and/or which have been proven over years of practice and thus have been established by us as a standardized solution. In addition, we offer you an expansion of our existing study designs, e.g., by integrating additional parameters or by transferring to another regulatory level. We also develop individual study designs. For an overview of the available studies, click on the appropriate product category.
We can examine the tolerability of your product with a series of epicutaneous tests. This determines whether a test product causes a reaction after application to the skin. The different test designs differ, e.g., in the duration of the application phase, the test area, and the type of application (open, semi-occlusive, occlusive). We also recommend appropriate designs for specific product categories.