Clinical trials

Early-phase and proof-of-concept studies

We are a highly specialized, academia-affiliated research center for early-phase and proof-of-concept clinical trials

Fraunhofer ITEM has many years of experience and expertise in the field of clinical airway research, complemented by a unique state-of-the-art infrastructure for performing clinical trials. Our focus is on airway diseases such as asthma, COPD, and allergic rhinitis, and on interstitial lung diseases, idiopathic pulmonary fibrosis (IPF) in particular.

At the Clinical Research Center Hannover (CRC Hannover), one of Europe’s leading-edge non-hospital clinical research centers, we operate in a collaborative working environment that includes outpatient clinics and overnight facilities for study participants, advanced medical equipment, magnetic resonance imaging (MRI) systems, and a state-of-the-art biobank for storing biological samples.

In cooperation with our partner at the CRC Hannover, the Hannover Medical School, we conduct clinical trials also in other therapeutic areas, mainly atopic dermatitis, psoriasis, and sleep disorders.

Fraunhofer ITEM scientists have developed a wide range of challenge models to test the human response, for example, to inhaled allergens (inhaled allergen challenge; Fraunhofer Allergen Challenge Chambers in particular). We have direct access to human samples such as bronchoalveolar lavage (BAL), sputum, serum, and plasma, and have our own immunological lab including flow cytometry, chip cytometry, and an MSD multiplex platform.

A large database of both prescreened patients (with asthma, allergic rhinitis, COPD, atopic dermatitis, or idiopathic pulmonary fibrosis) and healthy volunteers and a professional recruitment team ensure reliable time lines in the performance of clinical trials. Our research department furthermore has access to five challenge chambers – the Fraunhofer Allergen Challenge Chambers in particular – for proof-of-concept studies with sophisticated study designs using natural pollen (grass, birch), allergen extracts (e.g. cat, house dust mite), ozone, or hypoxia.

Our service portfolio for clinical trials

Fraunhofer ITEM clinical investigators perform early-phase clinical trials with new drugs and medical devices at the Clinical Research Center Hannover, one of Europe’s largest non-hospital clinical research centers.
© Fraunhofer ITEM

Fraunhofer ITEM clinical investigators perform early-phase clinical trials with new drugs and medical devices at the Clinical Research Center Hannover, one of Europe’s largest non-hospital clinical research centers.

Scientific consultancy

Identification of an appropriate proof-of-concept model and study design for your clinical trial

Development of study protocols

Conduct of clinical trials

Preparation of patient information and informed consent forms (ICFs)

Submission of requests for ethical review of monocenter clinical trials

Recruitment of patients and healthy volunteers

Update and archiving of trial-related documents

Process monitoring by a separate quality assurance department

Our clinical research methods and technologies

 

Challenge models

We have developed several challenge models, our unique Fraunhofer Allergen Challenge Chambers in particular, where pollen and other allergens can be dispersed in the air under controlled conditions.

Inflammation monitoring

Our repertoire for detailed observation and monitoring of inflammatory processes in the lungs includes a broad range of invasive and noninvasive methods.

 

Biomarkers

We process and analyze human biospecimens using a broad variety of innovative technologies and methods, including in-vitro disease models with primary cells.

 

Chip cytometry

Chip-based cell analysis, i.e. chip cytometry, allows iterative staining of cellular markers like in flow cytometry, but in addition enables analyses in stored samples.

 

Medical imaging

State-of-the-art imaging technology (MRI scanner for research only) enables noninvasive methods for quantifying morphological and functional biomarkers in our clinical research.

 

Respiratory diagnostics

Spirometry, bronchoscopy, body plethysmography, rhinomanometry, impulse oscillometry and others – we offer a broad spectrum of methods for use in clinical trials.

 

Fraunhofer Sputum Core Facility

Our experienced sputum center offers validated analytical methods for sputum analysis in multicenter clinical trials.

CRC Hannover – one of Europe’s largest clinical research centers

The CRC Hannover, one of Europe’s largest non-hospital clinical research centers, pools competencies in early-phase and proof-of-concept studies in different therapeutic areas.
© Fraunhofer ITEM

The CRC Hannover, one of Europe’s largest non-hospital clinical research centers, pools competencies in early-phase and proof-of-concept studies in different therapeutic areas.

The whole Fraunhofer ITEM clinical research team operates in the Clinical Research Center Hannover (CRC Hannover), one of Europe’s largest non-hospital clinical research centers. The CRC Hannover opened in 2014 and maximizes benefits for patients by enabling leading academic experts to pool their expertise and collaborate. In this clinical research center, three legally independent research organizations are working under one roof. While clinical investigators of Fraunhofer ITEM and the Hannover Medical School perform early-phase clinical trials with new drugs and medical devices, researchers of the Helmholtz Center for Infection Research are conducting here a part of Germany’s largest health study, known as “German National Cohort” study.

Read more about the CRC Hannover