From study planning to the final report
proDERM as a full-service institute
We are a leading international contract research organization specializing in the conduct of clinical studies in the areas of skin, mucosa, hair, eyes and mouth. We carry out studies on medicinal products, medical devices, cosmetics, nutritional supplements and consumer goods alike, and competently comply with the various regulatory and legal requirements. As a competent, full-service partner, we supervise your study project in all its phases – from planning to the preparation of the final report. In most cases, cooperation begins as early as the development of a suitable study design and continues with the obtaining of regulatory approval. After recruiting suitable patients or test subjects and then conducting the study in our clinical unit, the project is finalized by the departments of Data Management, Statistics, and Medical Writing.
proDERM | Your partner for trustworthy clinical studies.
In Dermatology, Oral Care, Ophthalmology, Hair Care, Women’s Health and Sun Care
Our offer includes the following services:
- Development of the test design
- Regulatory notification to an independent IRB or submission for approval to BfArM and Ethics or DIMDI (depending on the test product)
- Recruitment of the patients/test subjects
- Healthy study participants
- Special collectives such as rosacea, psoriasis, atopic dermatitis, etc.
- Study implementation, taking into account corresponding guidelines
- According to the Cosmetic Directive of the EU 76/768 EEC and EC Regulation 1223/2009
- According to ICH-GCP and the German Medicines Act (AMG)
- According to ISO 14155 and ICH-GCP, the Ordinance on Clinical Trials of Medical Devices (MPKPV) and according to the Medical Devices Act (MPG)
- Project management
- Quality management
- Data management
- Statistics
- Report creation
- Archiving
Consulting, Network Services, Site Management
We are pleased to support you with consultation well before the start of your clinical study. Here we analyze existing preclinical and galenic data when needed, or examine strategic options and specifications. We work out development plans from the start to the approval and design safety and efficacy studies tailored to your specific needs. We also have access to a pool of cooperation partners whom we have audited, thus offering you services that go beyond our core Phase I/II business. We have a well-established network of quality-certified, dermatological testing centers. These are managed and activated from a central position if our own recruiting possibilities are insufficient for recruiting all the subjects needed for a study.
- Toxicological investigations
- Formulation optimization
- Patient recruitment
- First-In-Man-Studies
- PK-Studies
- Studies with hospitalization
- Proof of Principle
- Legal representative
- Generation of Dossier
- Consulting related to market entry strategy
- IND
- Investigator Meeting
- Monitoring/Auditing
- Site Initiation
Contract research you can rely on
We deliver reliable and meaningful results
“Our understanding of quality is to make the highest demands on ourselves and our work”. Since our founding in 1994, this guiding principle, like no other, has shaped us in our day-to-day activities. As a result, you will experience the special “proDERM quality” reflected in our slogan “Research to rely on”, and which you will discover in the form of meaningful results.
But what does this mean exactly? Quality is nothing other than the ratio of actual properties to previously formulated requirements. Many institutions are content to comply with legal and regulatory requirements. Our philosophy, on the other hand, is to offer you a service based on the highest standards. We have summarized how we take these standards into consideration in our daily work using some case studies:
Quality management according to ISO 9001
The essential basis of our “quality” is, of course, our ISO 9001 quality management system, which supports us in fulfilling the described requirements with quality controls, internal audits, standard operating procedures, etc.
