Qualifications

All studies are conducted according to Good Clinical Practice standards (ICH-GCP).

Over several years we gained experience with clinical trials under German Medicine Act (AMG), ranging from toxicity and dose finding studies to pivotal licensing trials and observational studies after marketing (phases I – IV).

The Center for Clinical Studies is headed by Krista Stoycheva, an ICH-GCP trained physician with experience in internal medicine and international clinical trials.

The senior study coordinator, Andrea Glaewe, has a Certificate of Completion of Training (CCT) in Pharmacology and Toxicology and many years of experience in translational clinical research.

Our study nurses are certified by the German Association for Applied Human Pharmacology (AGAH). They ensure our high standards for the acquisition and documentation patient related data. All logistic operations, the appointment bookings, the reservation of laboratory capacities and diagnostic procedures as well as and the shipping of samples are co-ordinated by study nurses.

Our laboratory staff are familiar with most biomolecular methods that are currently in clinical and research use. Our infrastructure allows the processing, storage and shipment of biomaterials from patients without any delay.

Furthermore, associated members of staff provide us with statistical know how and access to the biobank of the Research Center Borstel.