The research division Clinical Research is divided into the departments Clinical Research at the Frankfurt am Main site, Clinical Research and Phase I Unit at the Göttingen site and Clinical Research and Phase I and II Unit at the Berlin site.
Clinical Research - Frankfurt am Main
The division consists of an interdisciplinary team, which includes Clinical Project Management and Medical & Scientfic Operations for the implementation of innovative biostatistical methods in case number planning and study design.. An in-house biomaterial bank for the supplementary collection of various biomaterials from serum to skin samples, allows the incorporation of these samples into basic scientific analysis and characterization of diseases. Through strategic networking with the Fraunhofer Institute for Intelligent Analysis and Information Systems IAIS, a partnership on Healthcare Analytics in Translational Medicine has been established that integrates state-of-the-art data science methods into translational research.
Clinical Projectmanagement AMG/Non-AMG
(Direction: Dr. Tanja Rossmanith)
For joint research projects and contract research in the Clinical Research department all necessary infrastructural prerequisites and the necessary expertise for conducting clinical studies in accordance with all national and international specifications, including studies according to AMG and MPG are available. A quality management system enables the conduct of investigator-initiated clinical trials under sponsorship of the Fraunhofer-Gesellschaft. The indication-specific expertise of specialists for all immune-mediated and inflammatory diseases is ensured by the close proximity and cooperation with the clinical centers of the University Hospital Frankfurt.
Medical & Scientific Operations & Characterisation of Immunopathology
(Head: Dr. Michaela Köhm)
The working group Medical & Scientific Operations provides a team of scientists and physicians to develop and implement care-relevant study ideas in cooperation with the clinics of the University Hospital Frankfurt. Through innovative study designs, project-specific statistical algorithms and the development of novel, specific outcome parameters such as the use of predictive, novel and innovative imaging, integrated solutions can be offered from the initial study idea to the final report, adapted to the respective problem. The innovative study ideas and their solution concepts can be implemented by the data management and biostatistics team and directly displayed in the data collection and evaluation. Additionally, clinical research projects with focus on Characterization of Immunopathology and biomarker development, e.g. for early diagnosis of immune diseases, are initiated and performed.
Early Drug Development & Human Pain Models
(Head: Dr. Carmen Walter)
The working group Early Drug Development has a modern phase I unit, in which studies of early clinical drug development (e.g. pharmacokinetics, pharmacodynamics, bioequivalence studies) can be performed under optimal conditions. An experienced and highly qualified team of (specialist) doctors and study nurses takes care of the study participants during all phases of their treatment.
The working group with its research focus in Human Pain Models can offer a wide range of high-quality clinical pharmacology services. Here, the scientific focus is pain, analgesia, smell and taste. Standardized methods of pain measurement are used, which, among other things, serve the development of analgesic drug candidates in healthy subjects.
(Head: Dr. Robert Gurke)
The working group enables measurements of small exogenous and endogenous molecules by coupling of liquid chromatography and mass spectrometry while adhering to the highest analytical standards. One focus is on measuring lipid mediators and determining their relevance in the pathogenesis of immune diseases. The mass spectrometry platform is also available for measurements of further analytes (e.g. drugs and their metabolites) as part of (clinical) research projects.
Clinical Research and Phase 1 Unit - Göttingen
(Head: Prof. Dr. Martin Weber, Göttingen)
The working group provides the infrastructure and human resources to carry out clinical studies in the early phases of drug development in the indication area neuroinflammation. A modern phase I unit and an excellent interdisciplinary team offer all the structural requirements for the use of new drug candidates in healthy volunteers and patients with controlled disease activity.
Clinical Research and Phase 1 and 2 Unit - Berlin
(Head: Prof. Dr. Markus Magerl, Berlin)
With a focus on mast cell-mediated diseases and their differential diagnoses, our study center conducts phase I and II clinical trials. The team, consisting of investigators and study nurses, conducts studies in collaboration with sponsors. The connection to the Charité - Universitätsmedizin Berlin with the corresponding clinical focus as well as the integration of our staff into the special consultation hours of the Charité ensure the necessary clinical expertise and efficiency in recruitment. For investigator-initiated studies, our institution can assume the sponsor function in mono- and multicenter studies from the beginning.