The Early Clinical Pharmacological Trial Unit KliPS plans, coordinates and conducts early phase clinical trials (phase 0/I/II, including first-in-human studies) in patients with various diseases and in healthy volunteers. It has a specialized infrastructure (intensive monitoring, overnight and day hospital and outpatient clinics) and is operated by specially and continuously trained staff. Due to a longstanding experience in the planning and implementation of translational projects we are capable to quickly and safely assure the transition from preclinical to first-in-human studies.
The trial center is part of a campus-wide network of Clinical Pharmacology Trial Centers, KliPSnet, which also includes the Pediatric Clinical Pharmacology Trial Center paedKliPS and the Pneumological Clinical Pharmacology Trial Center ThoraxKliPS.
We conduct drug trials on behalf of industry partners, in cooperation with academic partners and as self-initiated studies (IIT). In close cooperation with other departments of the campus we examine investigational drugs (biologics, vaccines, small molecules, active excipients) in patients with different, often oncological, infectious, cardiological or dermatological indications. For rare diseases, we reliably recruit patients and subjects (sometimes nationwide or using specific networks) in order to reach recruitment goals.
Click here for an overview of current cooperation partners of our trial unit.
IITs often focus on the quantification of individual differences (pharmacogenetics, elimination disorders, interactions) and are performed in cooperation with the Department’s Molecular Biology-Biochemistry Laboratory (genotyping, evaluation of biomarkers) and the Analytical Chemistry Laboratory (drug quantification in all matrices).