Clinical trials with medicinal products and medical devices

Be it the exclusion of an irritative or allergenic potential, the 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 carry these out 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. We are happy to conduct the following studies for you:

• Safety studies (Phase I)
• PK-studies (Phase I)
• Proof-of-Principle/Proof-of-Concept (Phase II a)
• Dose finding (Phase II a/b)

• Pivotal Studies (Phase III)
• Postmarketing Studies (Phase IV)
• Bioequivalence studies

Bioequivalence of topical medicinal products – the vasoconstriction test

In contrast to systemically available medications, there are very few possibilities for proving the bioequivalence of topically applied medications without a clinical study on patients. An important exception in this case is the corticosteroids. For these, we offer the vasoconstriction test in accordance with FDA guidance. Because of its comprehensive experience in conducting this test, proDERM already has a prescreened panel of “responders”. For other substances, it is increasingly possible to demonstrate bioequivalence by dermatopharmacokinetic parameters using Raman spectroscopy.

Clinical Assessment of Medical Devices

Now, with the 4th revision of the Guideline, the requirements for the evaluation, testing and certification of medical devices have increased significantly. Specifically, the Guideline now describes, in very much more detail, how and over what period of time a clinical assessment is to be conducted. In addition, specifications regarding the data collection and literature search are given. A significant modification is the compulsory handover of the assessment protocol that describes the methods used in the clinical evaluation and the steps performed. In addition, the room for interpretation in the use of data of a comparison product is significantly reduced by the Guideline’s revision.

In the framework of the certification of your medical device, our team of scientists and physicians is available to you as a competent service provider for clinical evaluations, and as a ‘Think Tank’. Our support ranges from well-designed, scientific studies on the conduct of literature searches to the creation of experts‘ reports or concept papers. It is especially in the case of semi-solid topical formulations for application to the skin or in the eye that our many years of experience in dermatology and ophthalmology excels.

Examples of this are artificial tears for application in the eye and products for the improvement of the skin barrier.