We employ physicians, study nurses, project managers and trial coordinators, data managers, statisticians and quality control managers, as well as recruitment personnel. All personnel undergo constant training on all the current legal and organizational aspects of clinical trials.
CTC North has its own study ward with 35 beds on the campus of the University Medical Center Hamburg-Eppendorf (UKE) (10 beds are used for continuous cardiovascular monitoring), which are available to trial participants and patients within the framework of clinical trials. As we conduct our own clinical trials on our study ward, our employees are trained on current regulations governing clinical trials and have first-hand experience in their implementation. All consulting carried out for clinical departments at the UKE by us is therefore backed up by direct experience.
Clinical trials include all scientific studies carried out in healthy volunteers and in patients, in which drugs or medical devices are tested or scientific data is compiled. A core team of physicians and other professionals maintains close contact with national and international authorities (Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) in Germany, the European Medicines Agency (EMA) in Europe), with regard to counselling, performance and implementation of clinical trials according to the Guidelines on Good Clinical Practice (GCP).