Services

The beds on the ward are equipped with monitors for the continuous logging and long-term storage of telemetric 12-lead ECG, pulse oximetry and blood pressure data. All monitored beds and the vital signs of all subjects can be viewed on a monitor via the care center.

As well as offering continuous nursing care and the potential presence of a physician around the clock, the ward is also included in the University Hospital’s emergency plan in order to guarantee maximum safety for subjects. The experienced trial team works in line with updated emergency standard operating procedures (SOPs) and is given regular training on basic life support (BLS) measures both in house and by colleagues from Anesthetics. A separate emergency management agreement is also in place with the Clinic for Anesthesiology and Surgical Intensive Care Medicine. The intensive care unit (ICU) is just a few minutes’ walk away in the same building complex. Trials can even be conducted under direct anesthesiological supervision if need be, ideal conditions for first-in-human (FIH), early-phase and other trials with stringent safety requirements for their subjects.

The Phase I Unit follows standardized processes in line with the regulations for Phase I/FIH trials, which can be adapted in line with the sponsor’s requirements or supplemented with the sponsor’s own SOPs as required.

The extensive list of SOPs is reviewed and updated by the quality management team at the central trial office of the Bonn Trial Center, and trial personnel are given regular training.

The University Hospital Bonn’s kitchen can prepare tailored meals that take account of various kinds of diet. This can be particularly useful in the case of food interaction trials, metabolic trials, dietetic products or active ingredients in food supplements but is also important for the well-being of our trial participants.

• Healthy subjects

Suitable subjects of any gender with different characteristics (smokers, age, allergy sufferers, etc.) can be recruited at short notice using an extensive database run in cooperation with the German Aerospace Center (DLR), among others. Additional public advertising for specific trials, e.g. in newspapers or on notices posted around the University, can also be arranged with minimal lead time if required.

• Patient populations

Cooperation arrangements with the relevant clinics provide access to the various patient cohorts that can be recruited from the outpatient clinics and wards at the University Hospital Bonn.

The TriNetX research platform enables trial organizers to gauge their recruitment potential over a certain period or even to identify specific possible participants by running pseudonymous searches of the University Hospital Bonn’s patient data using certain inclusion and exclusion criteria.

As a full-service hospital, the University Hospital Bonn comprises 38 clinics and 31 institutes and thus offers every option in terms of innovative patient care. These include diagnostic imaging and laboratory analysis methods as well as a wide range of surgical and interventional techniques for all patients, from newborns through to the very elderly. Trial projects in the Phase I Unit can also benefit from this expertise and the available personnel and infrastructure.

Needless to say, the measurements that are particularly important in a trial project include radiological imaging (ultrasound, X-ray, computed tomography (CT), magnetic resonance imaging (MRI)), cardiac diagnostics (long-term ECG/blood pressure, echocardiography) pulmonary diagnostics (lung function) and obtaining cerebrospinal fluid samples

We enjoy close links with the following departments in particular:

• Medical Clinic I (General Internal Medicine, Gastroenterology, Hepatology, Nephrology, Endocrinology, Infectiology)

• Medical Clinic II (Cardiology, Pneumology, Angiology)

• Dermatology

• Rheumatology

• Anesthesia and Intensive Care

However, we also run joint projects with specialist clinics from the Bonn Center of Neuroscience (Neurology, Neuro-Oncology, Psychiatry) and Pediatrics.

Just like a full-service CRO, the central trial office of the Bonn Trial Center provides personnel, expertise and infrastructure for planning and conducting clinical trials and fulfills the duties of a sponsor of regulated trials. It can supply comprehensive expertise for an early-phase clinical trial project if required:

• Regulatory affairs

• Project management

• Monitoring

• Biometrics

• Data management

• Pharmacovigilance

Working together with the Phase I Unit, therefore, it can perform all the responsibilities of the test center and sponsor for conducting trial projects.

• Storage

In the Phase I Unit, IMPs can be stored centrally at -80°C, -20°C, +4°C and room temperature under temperature- and access-controlled conditions in air-conditioned, sealed rooms.

• Preparing IMPs and reconstitution

The Phase I Unit has its own pharmacists and physicians with the experience needed to prepare IMPs for which there is no GMP-compliant manufacturing process or that need to be manufactured in a cleanroom. Needless to say, reconstitution can be done easily.

• Hospital Pharmacy

The central Hospital Pharmacy at the University Hospital can be involved in the manufacturing and storage processes if required. It offers cleanrooms for sterile production and the manufacture of cytotoxic drugs in cleanliness classes B to D as well as staff with the relevant specialist expertise. There are also additional options here for storing IMPs at -80°C, -20°C, +4°C and room temperature under temperature- and access-controlled conditions.

The Phase I Unit has the capability and expertise required to conduct and evaluate specialized pain simulations using the cold pressor test. This is particularly relevant as a way of gauging the analgesic effects of new compounds in healthy subjects and can provoke cardiovascular effects at the same time. The effects can also be compared against the pharmacokinetic data on the active ingredients.

The Phase I Unit is a clinical and pharmacological partner of the RePo4EU consortium, which advises on, plans and implements drug repurposing strategies. Where requested by the authorities, Phase I trials help in particular to confirm safety in the case of higher doses, combinations of active ingredients or specific populations.

We can provide you with comprehensive advice on relevant strategies, put you in touch with the right people and plan and conduct your trial projects for you.

• The BioBank Bonn supports clinical and translational research as well as basic research, e.g. into developing diagnostic, prognostic and predictive biomarkers for specific illnesses. This involves collecting, storing or supplying biological samples and their derivatives (whole blood/serum and other bodily fluids or tissues) in accordance with the applicable SOPs). Most storage is done at -80°C, although there is capacity to bring this down as far as -170°C if needed.
• Clinical data associated with the samples can also be stored in the BioBank Bonn’s database.
• If required, samples can be subjected to specialist assays and corresponding analysis results generated or the samples sent on to partners.
• The following assays are offered as standard:
  • Extraction of nucleic acids
  • Peripheral blood mononuclear cell (PBMC) isolation
  • Separations of cell subpopulations
  • Cytokine release assays

• Clinical chemistry

The central laboratory of the University Hospital Bonn can provide support within the institution and offers instant analysis of biological samples. All the analyses that a full-service hospital might require can be carried out here:

• Clinical chemistry
• Hematology
• Hemostaseology
• Immunology (allergy diagnostics, autoimmune diagnostics)
• Endocrinology
• Tumor markers
• Specific diagnostics (e.g. electrophoresis, high-performance liquid chromatography (HPLC), oligoclonal bands)
• Reference laboratory
• Therapeutic drug monitoring and pharmacokinetic analyses

• Basic research

The scientific work at the Institute of Clinical Chemistry and Clinical Pharmacology focuses particularly on viral immunology, immuno-oncology, exosomes, circulating nucleic acids and therapeutic oligonucleotides. The individual working groups can lend their expertise to planning and developing specific immunological questions and their diagnostic readouts. Tailored exploratory investigations can be formulated based on the following assays:

• Cell culture
• Immunophenotyping
• Functional immunoassays in whole blood, in PBMC or on isolated cell fractions
• Cytokine release, surface expression, killing, gene expression, etc.
• Fluorescence activated cell sorting (FACS) analyses
• NanoString expression analyses
• Meso Scale Discovery (MSD) cytokine multiplex assays
• Developing new assays in consultation with the client
• SNP/methylation/mRNA/miRNA analysis
• Sequencing using next-generation sequencing

The possibility of validating these assay methods can also be explored if required together with the central laboratory and the quality management team at the central trial office.

• Laboratory for specific lipid subanalysis

The laboratory led by Professor Lütjohann has been conducting research into the cholesterol and bile acid metabolism for over 30 years. It has developed a number of analytical tools to detect and monitor the progress of therapy in the case of hypercholesterolemia and in situations including rare congenital disorders of the cholesterol and bile acid metabolism, both at cellular level and in vivo or ex vivo.

ImmunoSensation is a Cluster of Excellence funded by the German Research Foundation (DFG) that studies innate immunity beyond the boundaries of traditional immunology. Its researchers include immunologists, neurobiologists, system biologists and mathematicians from the Faculty of Mathematics and Natural Sciences at the University of Bonn as well as the German Center for Neurodegenerative Diseases, which is part of the Helmholtz Association.

It aims to advance innovative research into potential treatments and support clinical research in the context of conducting trial projects. Besides providing access to expert advice, it also allows working groups to get directly involved in evaluating and interpreting trial results, most notably through developing and integrating laboratory assays.

The close relationship that we enjoy with the Clinics for Cardiology and Pneumology, Diagnostic and Interventional Radiology, Neuroradiology and Nuclear Medicine at the University Hospital Bonn means that diagnostic and imaging procedures for examining clinical trial patients can be organized at any time.

These include:

• Computed tomography (CT)
• Magnetic resonance imaging (MRI)
• Positron emission tomography (PET-CT)
• Scintigraphy
• X-ray diagnostics
• Ultrasound examinations
• Echocardiography