Center for Clinical Trials: Our range of services

The Center for Clinical Trials (ZKS) at MHH offers academic researchers, as well as pharmaceutical and medical device companies, first-class conditions for competent and rapid implementation of all phases of their clinical trial - "on time and on budget" at Hanover Medical School (MHH ).

CRO - Services for IITs and for industry sponsors

We serve all aspects of an academic CRO for the successful realisation of AMG and MDR/MPDG - projects, as well as non-interventional studies for Investigator Initiated Trials (IITs) with MHH sponsorship and contract research projects with external sponsor:

• Initial inquiries regarding projects and studies in collaboration with ZKS (CRO Services) or the Phase I Unit (ECTU)
• Clinical Trial Consulting and Project Planning
• Clinical Project Management
• Clinical Monitoring
• Budget Planning & Financial Management
• Sponsor MHH - Quality Management
• Quality Management in Clinical Trials
• Regulatory Affairs (Submissions to Regulatory Authorities, Medical Writing, Key Data for MHH)
• Data Management (using MARVIN from AB Cube and SecuTrial from interActive Systems)
• Biometrics & Pharmacovigilance (in cooperation with the Departments of Biometrics and Clinical Pharmacology at MHH)

Experienced phase I unit for early and translational Proof of Concept (PoC) trials including First in Human (FIH) trials

The Clinical Research Center Hanover provides your research-based pharmaceutical company with a fully equipped clinical-operative Early Clinical Trial Unit (ECTU) that has been employed by MHH since 2014 and that has retained its Early Phase Medical Team from that time on. Here, healthy volunteers and patients who are generally mobile and do not require special care can be treated and medically monitored as part of early phase study protocols. The clinical trial unit is operated together with CRC partner Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), with both legal entities, Fraunhofer ITEM and MHH, employing their respective medical early phase teams in the CRC at the ECTU.

Clinical research in all indication areas and development phases (I - IV)

ZKS covers every development phase in clinical research and every medical indication area, with the research priorities of the MHH - 1) infection and immunity 2) transplantation and regeneration 3) biomedical technology and implants 4) oncology (the latter in close cooperation with the CCC Lower Saxony) - at its core and works closely with the clinics of the MHH as a university clinic for supramaximal care and all MHH teaching hospitals in the Hanover region in order to ensure the timely recruitment of patients.

FRMU Contract Consulting Services

The FRMU provides support with business issues relating to economic projects with a volume > 50,000 € according to the MHH third-party funding guideline. Consulting services include financial and risk management as well as developing a budget proposal.