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Clinical Technologies Implementation

Clinical Technologies Implementation includes:

  • Integration of diagnostic and therapeutic nuclear medicine instruments in the early phases of drug development programmes
  • Specialised advice, planning, organisation and coordination of clinical trials under the general regulations regarding radiation protection legislation (StrSchV, RöV, EURATOM etc.)
  • Expert package for the application of radio-immunological therapeutic procedures
  • Cooperation with corresponding internal and external University Medical Center partners

The integration of functional imaging and therapeutic nuclear medicine technologies mainly in the early phases of drug development (Clinical Technologies Implementation; CTI) is relatively young and has significantly influenced drug development concepts in the pharmaceutical industry in particular for dose finding and dose regime studies. Functional imaging procedures in nuclear medicine enable, for example, direct radiolabelling of drugs, thereby allowing for the depiction of the mechanism of action. The newly installed area of CTI in the Clinical Trials Center Freiburg accommodates this development and advises the sponsors in drug development programmes regarding all possible radiation protection issues during clinical trial protocol preparation (StrSchV, RöV, EURATOM etc.) or in the development of new therapy concepts (e.g. radio-immunotherapy, receptor-mediated internal radiotherapy etc.). The CTI division should be understood within the specialist field of radiopharmaceutical studies as an interface to the following existing Clinical Trials Center Freiburg units:

  • Medical project supervision
  • Study Assistance
  • Project Management

This means that through the Clinical Trials Center Freiburg, clinical studies from the special areas of nuclear medicine/radiopharmacy/radiology can also be planned, conducted, coordinated, evaluated and assessed. The particular infrastructure necessary for this purpose of cooperating partners for nuclear medicine or radiology can be constructed by the Clinical Trials Center Freiburg.

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