Early Clinical Trial Unit (ECTU)

The ECTU, housed in the Clinical Research Center Hannover (CRC), offers 20 phase I beds in an intermediate care setting, as well as outpatient clinics, special diagnostic rooms and other professional infrastructure for conducting early clinical trials of phases I to IIa, as well as experimental proof of concept trials. Under the umbrella of a highly developed quality management system, the focus is on quality-assured drug development and research into new modes of action.

In MHH trials at the translational infrastructure Clinical Research Center (CRC), a Principal Investigator (PI) from an MHH specialist clinic always works closely with the ECTU study team (OE 8660). The ECTU, which is integrated into the ZKS staff unit, acts as a translational Clinical Trial Unit (CTU) and Site Management Organization (SMO).

The ECTU team supports the clinical researchers and project managers right from the project initiation phase for all contract research studies planned at the MHH. Basic clinical-operative feasibility issues are examined, including the selection of the investigational site within the MHH.

In case of the CRC being chosen as investigational site for an early clinical trial, the ECTU team supports the scientific project management with highly qualified study staff (investigators, study nurses, medical record specialists) in designing and implementing all the operational, medical, and scientific tasks within the framework of the clinical trial management and documentation. The ECTU provides overall organizational support for the implementation of the project at the CRC in order to ensure that the project runs smoothly and that all necessary study activities of the project are integrated into the quality assurance systems of MHH and CRC.