CRC - Early Clinical Trial Unit (ECTU)

Center for Early Clinical Trials and Drug Research

The Clinical Research Center (CRC) with its 20-bed translational Clinical Trial Unit, outpatient clinics and special diagnostic room’s offers professional infrastructure for conducting early phase clinical trials I - IIa) as well as experimental proof of concept studies. Under the guidance of a highly developed quality assurance system, the focus is on quality-assured drug development and research into new mechanisms of drug action.

In MHH studies at the CRC, a Principal Investigator (PI) from an MHH specialist clinic always works closely together with the study team of the MHH - Early Clinical Trial Unit consisting of GCP-trained physicains, nurses and medical documentalists. MHH - Early Clinical Trial Unit supports clinical researchers and project managers in the project initiation phase for all contract research studies planned at the MHH. Questions of basic feasibility including the choice of the investigational site can be discussed.

If an early phase trial is also conducted clinically and operatively at the CRC Hannover, the MHH - CRC Early Clinical Trial Unit - Team supports the scientific project management with highly qualified study personnel also in the planning and execution of all operative, medical and scientific tasks including study execution and study documentation. The MHH - Early Clinical Trial Unit provides the project management with overall organizational support for the implementation of the project at the CRC Hannover in order to ensure a fluent project flow and the integration of all necessary study activities of the project into the quality assurance system of the CRC Hannover.

The increasingly demanding legal requirements (AMG, MPG, ICH GCP) and framework conditions for the conduction of clinical trials, which are becoming more and more stringent worldwide, but especially in Germany, require that university hospitals establish and maintain professional structures and, in particular, sustainable personnel competencies in order to fulfil the university's core task of "conducting clinical drug research".

MHH Guideline “Trial Conduction of early clinical trials at the MHH” – please press here!

 

Please send study requests directly to:

Prof. Dr. med. Christoph Schindler

 

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