Clinical Research Services for Dermatology Ophthalmology Allergology Oral Care About proderm Approach Service Study types Equipment Quality Consulting Site Management Publications
2 3 About proderm 2011 Establishment of Sensory Laboratory 86 95 75 2007 Incorporation of Oral Care Clinic Trusted Partner What started as a dermatological CRO in 1994 is today a clinical research service provider with an unmatched range of methodology, equipment and highly dedicated scientific experts. 50 43 2002 Start of Hair Care Laboratory 36 proderm was founded in 1994 by Klaus-P. Wilhelm, MD, Professor of Dermatology, a renowned specialist in dermatopharmacology and dermatotoxicology. 2000 Establishment of Deodorant and Antiperspirant Facilities With the motto 'Dedicated to Skin', the proderm research team has been dedicated since then, body and soul, to conducting clinical dermatological studies. 23 29 This clear focus has been expanded over the years by other core areas such as the indications of ophthalmology, oral hygiene and hair care. Nevertheless, 1997 Opening of Sun Protection Laboratory even after almost 20 years of work, proderm stands primarily for one thing: Continuity! 16 Continuous growth, continuous leadership, continuous independence - last but not least a continuously expanding scientific methods of highest quality. 1995 Implementation of Pharmaceutical Division 1994 Foundation of proderm # of employees: 4 # of studies p.a.: 40 5 Milestones No. of employees
4 5 Services Full Service From early phase consulting until archiving of study data - we are the professional, flexible, and trustworthy partner for your development project. proderm covers all aspects of a clinical trial. Thus, customers have the opportunity to individually define the type and scope of the desired service from our range of services. Cooperation usually starts with the development of an optimal study design and continues with obtaining the regulatory approval. After suitable patients or volunteers are recruited and the study is conducted in our clinical unit, the project is finalized by Data Management, Statistics and Medical Writing. Regardless of the type and scope of the project, with a total of 95 employees, we always assure that there is a substitute for all functions. With that we can react with high flexibility to the needs of our customers, even in times of high workload. a Consultancy a Regulatory Approval a Patient Recruitment a Project Management a Data Management a Statistics a Report Writing a Archiving
6 7 Approach Providing Professional Solutions Dedicated experts, innovative equipment and experience are the success ingredients of the professional solutions we offer for both individual and standard study objectives. We combine our passion for clinical research with our approach towards quality. For this reason, proderm stands not only for dedication, but also for professionalism, scientific methods and innovation. a Professional a Scientific a Innovative This is the foundation of our daily work, in which the needs of our customers take center stage. This is also our impetus for continuously striving for improvement. There are no differences made. Whether a top ten global player, a medium-sized enterprise or a startup, whether a standard test or an individual study design our principles are applied to all projects at all times.
8 9 Study types Safety & Tolerance Efficacy & Claim Support proderm conducts clinical phase I/IIa trials for pharmaceuticals, medical devices, cosmetics, food supplements and consumer products. In most cases, it is a matter of proving the tolerability or efficacy of topically applied products. Systemically acting products are also investigated as long as the primary target criteria are the effects on the skin or mucous membrane. With the proderm Pharma and proderm Cosmetics departments, proderm is embracing the fact that the regulatory environment and thus the conditions for a clinical trial vary greatly depending on the product to be tested. Under the direction of Dr. Reinhold Gahlmann, proderm Pharma investigates in predominantly monocentric trials: the local tolerability of topical medicines the bioequivalence of corticosteroids the efficacy of drugs or topical medical devices in proof-of-concept studies. At the same time, proderm Pharma has a network of qualified investigators in clinics and practices for multi-center studies. a Pharmaceuticals a Medical Devices a Cosmetics a Food Supplements a Consumer goods a Skin Care a Oral Care a Hair Care a Eye Care a Sun Protection a Intimate Hygiene Stefan Bielfeldt and his team in the proderm Cosmetics Division focus on the tolerability and proof of efficacy of cosmetics, food supplements and consumer products.
10 11 Equipment Experienced, Innovative, One of a Kind The multitude of innovative technologies (i.e. Raman Spectroscopy) and the extensive knowledge of our researchers to apply these techniques make us a one of a kind CRO. Our technical equipment goes far beyond known standards and is unique in the global CRO landscape. Thus, we are, for example, one of the few institutes that can offer the non-invasive technologies of confocal microscopy and Raman spectroscopy in combination. At the same time, we set benchmarks by our own developments. With our USR-CliP (Unit for Standardized and Reproducible Clinical Photography), we can, for example, achieve a high level of reproducibility and color fidelity in clinical photography. Our MacIS (Macroscopic Imaging System), on the other hand, allows unparalleled standardized macro photography. a 3D Scanners for Profilometry a In-vivo Confocal Microscopy a In-vivo Confocal Raman Spectroscopy a Clinical Photography a IR Thermography a Laser Perfusion Imaging a Radiometers a Videomicroscopy a UV Radiation Devices a Force Meters In our tests, we combine the various technologies in a validated environment and can thus present our sponsors with undreamt of solutions.
12 13 Quality Comprehensive Quality Management and ISO Certification Our service is of high quality, and we attach great importance to this. It is therefore not surprising that our quality management system goes far beyond the standards and we are the first German dermatological CRO to have received ISO certification. Compliance with ethical standards, current legal requirements and standards, the assurance of credible and valid data, reliable compliance with target dates and, last but not least, the continuous improvement of our products and services are aspects that we emphasize in our quality management system. Our system of standard operating procedures, quality control, qualification and training has proven itself in audits by customers and authorities, and is certified according to ISO 9001. a Quality Control a System Audits a Study Audits a Validation a Qualification a Training
14 15 Consulting 100 Years of Clinical Research Experience Make use of our problem-solving capabilities and go the right path from the very beginning. You are not going the way of the standards but are blazing a new trail with your product. Your innovative formulations require a pioneering spirit and scientific excellence of the clinical implementation. Your product offers properties that cannot be proven by conventional methods. Institute founder Prof. Dr. Klaus-P. Wilhelm and the senior consultant team with Dr. Reinhold Gahlmann, Stefan Bielfeldt and Dr. Dorothea Wilhelm will steer your project in the desired direction from the very start with their over 100 years of combined experience. In addition, you will be taken care of by experts who, with experience from more than 6,000 studies and over 30,000 examined products, will hold the steering wheel firmly in their hand and accompany you on your way with advice and action to solve even the greatest challenges. a Comprehensive publications a Comprehensive academic network a Close contacts to responsible authorities a Active in national and international working scientific groups and societies Because of our extensive inventory of technical equipment, you will benefit from a maximum of flexibility and methods developed explicitly for your project..
16 17 Site Management Publications Beyond Phase I: Hospitals and Dermatologic Offices Master the multicenter challenge with the proderm network of qualified investigators. The distinctive idea of service, the passion for clinical research, the demands for quality and professionalism - our test centers have been qualified in multiple ways in order to be included in our network of clinical testing facilities. As the primary responsible CRO, we will gladly support your project with this established network through and beyond phase I in the multicenter phases of development. Of course, the multicenter study can also be the start of our collaboration. Whether starting or continuing a successful cooperation, we assume the following tasks: Creating the test protocol Obtaining the regulatory approvals and ethics opinions Organization of the investigator's meeting Training & evaluator calibration Site initiation Monitoring Data management Statistics Report writing Extract of recent Publications Bielfeldt S, Röck C and Wilhelm KP, Chances and limits of an improved method to assess water resistance of cosmetic sunscreen products in vitro on polymethylmethacrylate plates. Int J Cosmet Sci: 1-5, 2012. Bielfeldt S, Henss R, Koop U, Degwert J, Heinrich U, Jassoy C, Meyer J, Tronnier H, Jentzsch A and Blume G, Internet-based lay person rating of facial photographs to assess effects of a cleansing product and a decent cosmetic foundation on the attractiveness of female faces. Int J Cosmet Sci: 1-5,2012. Wilhelm D, Himmelmann A, Axmann E-M, Wilhelm K-P, Clinical efficacy of a new tooth and tongue gel applied with a tongue cleaner in reducing oral halitosis, Quintessence Int, 43:709 718, 2012 Daehnhardt-Pfeiffer S, Surber C, Wilhelm K-P, Daehnhardt D, Springmann G, Boettcher M, Foelster-Holst R, Noninvasive stratum corneum sampling and electron microscopical examination of skin barrier integrity: pilot study with a topical glycerin formulation for atopic dermatitis, Skin Pharmacol Physiol 25, 155, 2012. Steiling W, Buttgereit P, Hall B, O'Keeffe L, Safford B, Tozer S and Coroama M, Skin exposure to deodorants/antiperspirants in aerosol form. Food Chem Toxicol, 50: 2206-2215, 2012. Bielfeldt S, Böhling A and Wilhelm K-P, Bioengineering methods to assess aging parameters in the depth of the skin. SOFW Journal, 137: 2-9, 2011.
proderm Institute for Applied Dermatological Research GmbH Kiebitzweg 2 22869 Schenefeld/Hamburg Tel: +49-40-839 358-0 Fax: +49-40-839 358-39 www.proderm.de