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Quality Management

Ensure and managing quality

CTCC understands clinical Research as backbone of patient care.

CTCC is obligated by the University of Cologne (UoC), by national law (i.e. AMG, MPG) and international regulatory bodies (i.e. ICH-GCP, DIN ISO 14155, DIN ISO 9001) to uphold quality standards. The quality management of the CTCC tends to ensure all quality relevant processes, arrangements and procedures. CTCC is certified in accordance with DIN ISO 9001. This signet stresses our ambition to fulfill expectations of clients, partners, providers and staff in order of legal requirements and our own approach.

Tasks

Quality Management

  • Development, Establishment and safeguard according to determined (international) quality standards
  • international quality assurance
  • Certified in accordance with ISO 9001

The quality management mandate of CTCC contains the following components:

  • Continuous management and updating of a comprehensive system of Standard Operating Procedures (SOP).
  • Verification that centralised work processes in confirmation with SOPs.
  • Continued training of staff through regular courses as well as internal and external advanced education.
  • Participation in national and international specialty committees, i.e. in the Network of the Coordination Centers for Clinical Studies (KKS Network) and in the European Clinical Research Infrastructure Network (ECRIN). 

Name

Titel

Function

Fon +49 221-478-

Fax +49-221-478-

Email

Meta, Drita

 

Quality Management Lead

88148

88209

drita.meta[at]uk-koeln.de

Schwanke, Uwe

Dr. rer. nat.

Quality Management

84641

88209

uwe.schwanke[at]uk-koeln.de