Quality assurance and process improvement

- Conducting GCP audits for clinical trials, for example in preparation for external audits or inspections

- Support for audits by third parties (incl. official inspections)

- Supporting the MHH trial sites on overarching quality management topics (including DIN EN ISO 9001)

- Collaboration in process improvement in cooperation with various MHH Facilities or Institutions, e.g. inspection bodies, Ethics Committee, Legal Department, Third Party Funding Department and/or zQM

- Nursing and further development of the quality management systems in the ZKS and in cooperation with Fraunhofer ITEM in the CRC.