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 and 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 Writing, Clinical Trial Design and Scientific Operations
(Head: Dr. Stephanie Dauth)
The Medical Writing, Clinical Trial Design and Scientific Operations group consists of three thematic units:
Unit “Medical Writing and Science“ (MuW)
In the context of clinical (AMG and non-AMG) studies and research projects, the MuW unit is responsible for conducting background research, planning project/study content and preparing all necessary documentation. Together with other units and medical experts, the MuW unit develops clinical studies and funding applications (e.g., BMBF, IMI, Horizon) and conceptualize s them as required. Synopses, applications, and study-relevant documents such as clinical study protocols, patient information, and briefing documents for authorities are prepared and presented both internally and externally. Once the study/project is complete, the results are interpreted within the unit and in collaboration with other participants, and are recorded in reports. This is followed by preparing publications, abstracts, presentations and posters for congresses. The MuW unit is the point of contact for all content-related aspects of the studies/projects.
Unit “Biostatistics“
The statistical study planning, supervision and evaluation of clinical trials and other studies (according to AMG, ICH or BO) is a central role of the biostatistics unit. The main tasks are statistical conceptualization, randomization, preparation of estimands and creation of the Statistical Analysis Plan (SAP). Particular focus is given to phase II proof-of-concept studies using innovative study designs (quality-by-design).
The biostatistics unit also plays a part in national and international research projects, e.g., on topics such as eHealth and early diagnostics, in which machine learning methods are employed for reducing the dimensions of high-dimensional 'real world' and OMICS data, and classify them through supervised and unsupervised learning. We also support the characterization of data lakes, data standardization (OMOP, OMICS) and their correlations and visualizations for the development of predictive models.
Unit “Data Management”
We offer a comprehensive range of data management services for clinical trials and scientific research projects, covering everything from planning and implementation to quality assurance:
- Structured data processes: Planning, controlling and harmonizing of all data processes in accordance with current regulatory and data protection requirements (e.g. GCP).
- Data security and quality: Validated preparation of study data for statistical analysis and transfer to biostatistics.
- eCRF development: Designing, implementing and programming of electronic case report forms (eCRFs) using proven EDC systems such as REDCap and SecuTrial.
- Standardized data entry: Validated and compliant entry of clinical study data and medical coding in accordance with to recognized standards.
- Project support: Professional support throughout the entire course of the study, from preparation to completion.
Our approach ensures the quality of the clinical trial data, creating a reliable basis for valid and reproducible results.
Inflammation Medicine and Characterisation of Immunopathology
(Head: Dr. Michaela Köhm)
The working group Inflammation Medicine 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 and Human Pain Models
(Head: )
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.
Biomedical Analytics
(Head: Dr. Robert Gurke)
The working group enables precise analysis of small exogenous and endogenous molecules through coupling of liquid chromatography (LC) and gas chromatography (GC) with mass spectrometry (LC-MS and GC-MS), adhering to the highest analytical standards. A particular focus lies on characterizing the metabolome and lipidome, with an emphasis on lipid mediators, to decipher their role in the pathogenesis of immune-mediated diseases. Alterations in metabolite and lipid metabolism are meticulously captured and correlated with disease mechanisms.
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP 