Expertise

CTC North employs physicians, study nurses, project managers and trial coordinators, a data manager and quality control manager, as well as recruitment personnel.

All personnel undergo constant training on all the current legal and organisational aspects of clinical trials.

CTC North has its own hospital ward with 26 beds at the University Medical Center Hamburg-Eppendorf (UKE) (6 beds are used for continuous cardiovascular monitoring), which are available to trial participants and patients within the framework of clinical trials.

As CTC conducts its own clinical trials, all employees of CTC North are informed 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 CTC North is therefore backed up by direct experience.

Clinical trials include all scientific studies carried out on human volunteers (i.e. on healthy trial participants and on patients), in which drugs or medical products are tested or scientific data is compiled. A core team of physicians and other professionals maintains close contact with national and international monitoring institutions (Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) in Germany, the European Medicines Agency (EMEA) in Europe, and the Food and Drug Administration (FDA) in the USA), with regard to counselling, performance and implementation of clinical trials according to the Guidelines on Good Clinical Practice (GCP).

Since the CTC North quality management system was certified according to DIN EN ISO 9001-2000 in November 2006, which met with a very positive response from clients in the pharmaceutical industry, CTC North now meets the highest demands on reliability, data quality and compliance with recruiting and timelines required in controlled clinical trials.