UZ Leuven

The Clinical Research Unit provides a professional environment for conducting both phase I and early phase II clinical trials. Being located within one of Europe’s largest University Hospitals (UZ Leuven, about 2 000 beds) and being part of the Catholic University of Leuven (over 25,000 students), our unit has access to a large pool of healthy volunteers, specific patient populations and a wide range of hospital facilities.

The Clinical Research Unit has a large database of healthy volunteers (over 1,000 subjects) which is continuously being updated. The database includes young males and females, sterilized and postmenopausal women, smokers and non-smokers. To date, the Unit has focussed mainly on phase I research, particularly first time in man administrations, and conducted over 130 clinical studies including:

The incorporation of pharmacodynamic assessments and surrogate markers in phase I research is a specific area of interest. Pharmacodynamic tests which have previously been applied in clinical studies include:

Furthermore, close collaboration with the Center for Molecular and Vascular Biology enables us to perform clinical trials for which specialized coagulation assessments need to be performed. In collaboration with the Departments of Radiology and Nuclear Medicine, the Unit is also involved in phase I studies incorporating advanced imaging techniques (e.g. PET, MRI) in early drug development.

The Unit has a capacity of 12 beds for prolonged overnight stay. All studies are performed in compliance with the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and are approved by the Ethical Review Committee of the University which meets every month. The computerized environment allows our qualified staff to perform efficient and accurate data management according to the highest quality standards and regularly updated Standard Operating Procedures (SOPs)

Safety is a major issue in clinical research. Therefore, regular training in advanced life support, continuous updating of the emergency department about the ongoing trials and permanent on-site supervision by an anesthetist during intravenous drug administrations, are part of our standard safety precautions.

For an overview of research activities, a list of publications is provided.

For further information please contact us.

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