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MHH - CRC Core Facility and Financial Risk Management Unit (FRMU)

MHH – Clinical Research Center (CRC) – professional translational infrastructure for early phase clinical trials and drug research

 

The MHH - Clinical Research Center (CRC) provides professional infrastructure for the organization and clinical conduction of early phase and proof of concept clinical trials for clinician scientists from all MHH clinical departments. Key priorities are quality controlled drug development and investigation of new mechanisms under the umbrella of a highly developed quality assurance system.

 

At CRC, early phase trials are conducted in close collaboration between a clinician scientist as Principal Investigator (PI) and clinical operational expert staff of the MHH - CRC Core Facility, which acts as Clinical Trial Unit (CTU) and Site Management Organization (SMO) of the MHH at CRC.

 

As Site Management Organization, the MHH - CRC Core Facility provides organizational support for the implementation of the study project at the CRC in order to ensure a smooth project flow and the integration of all required study activities of the project into the quality assurance system of the CRC.

 

The worldwide increasing regulatory requirements for clinical trials (Drug and Medical Device Act, ICH GCP) are becoming more and more demanding, which is especially true in Germany. Therefore, Medical Universities are required to provide specialized structures and in particular professional staff to fulfill the core responsibility of “conducting clinical research”.

Financial Risk Management Unit (FRMU)

 

The FRMU supports and advises Clinician Scientists and PIs of MHH in the calculation of contract research study site budgets. This includes financial and risk management, development of a site budget proposal and preparation and/or execution of negotiations with pharmaceutical sponsors.

Feasibility requests:

Prof. Dr. med. Christoph Schindler, Head MHH - CRC Core Facility
Phone: +49 511/5350-8300 or
E-Mail: MHH-CRC.feasibilitymh-hannover.de