Investigational site - Clinical research units
proderm has been operating its own Clinical Research Unit in Schenefeld/Hamburg - Germany. Since 1994 we are offering our extensive dermatology expertise, high-quality data and an ongoing success story in recruitment of subjects in our Headquarters in Schenefeld and since 2018 also in our additional Unit in Elmshorn 40 km north-west of Hamburg. The proderm clinical research units can be leveraged as a site in studies managed by our CRO or as an independent site for single or multicenter studies.
Our experienced and regularly trained staff consists of permanently employed and on-demand dermatologists and medical specialists, study nurses and recruitment personnel.
The proderm research units are equipped with highly specialized equipment:
- Fully air-conditioned (temperature and humidity controlled) examination rooms
- Extensive equipment for clinical photography
- Confocal microscopy and LC-OCT
- In vivo Raman spectroscopy
- State-of-the-art skin measurement equipment e.g. corneometer, tewameter, skin pH meter
- Medical examination devices e.g. Yeaple Probe, slit lamp, Tonometer
At our site we run:
- Safety and efficacy studies
- Dose finding studies
- Pivotal studies
- Post Market Follow-Up studies (PMCF)
- Bioequivalence studies (overnight stay in collaboration with Phase I partner unit in close proximity)
- Antioxidant and biomarker studies
- Serum and biopsy sampling and analysis
To accommodate even larger or very special patient populations, we have established our network of currently more than 40 pre-qualified investigational sites located in the DACH area.
While selecting external study sites, we consider among other things the following criteria:
- Indication and specialization
- Qualification (trained in GCP, ISO 14155)
- Ability of in-time recruitment patients
- Site description (facilities, team, resources)
- No competitive studies
- Accessibility, timely feedback and availability of PI and study team
In addition to these single center or multi-center phase I/II/IV trials or trials with medical devices we also participate in phase III multi-center trials as a study site or managing CRO.