Dept. of Clinical Pharmacology and Pharmacoepidemiology
Dept. of Clinical Pharmacology and Pharmacoepidemiology
Dept. of Clinical… KliPS

Early Clinical Pharmacological Trial Unit (KliPS)

The ISO 9001-certified Clinical Pharmacological Trial Unit (KliPS) plans, coordinates, and conducts early phase (Phase I/II) clinical trials, including first-in-human trials. These trials include not only Investigator-Initiated Trials (IITs), but also sponsored trials, in cooperation with partners from the Center for Internal Medicine and other departments of the hospital as well as with industry partners.

Patients and healthy volunteers are treated in the trial center as inpatients, day patients and outpatients within the framework of trials on various clinical pictures. Phase I trials with healthy volunteers are often the first and necessary step into the clinical development of a new drug. The Heidelberg campus offers an excellent environment for recruiting reliable trial participants.

An experienced team of investigators and study nurses,  state-of-the-art equipment and the connection to the Center for Internal Medicine offer an ideal environment for GCP-compliant trials.  To date, more than 140 studies have been conducted with a wide variety of drugs (chemical molecules, antibodies and RNA as therapeutics) as well as with therapeutic and preventive vaccines in various indications.

Head of Section


Our Vision


Clinical trials that investigate innovative compounds promote better drug therapies.


Our Mission


We support the translation of new compounds with our clinical expertise. Through high quality in the planning and conduct of clinical trials, we create safety for trial patients and healthy trial participants and ensure valid results as a basis for a later successful application of the new drug.

AREAS OF INTEREST

Early Clinical Trial Unit KliPSGCP-compliant trials with patients and healthy volunteersFirst-in-Human trials
early phase clinical trials in inpatient/outpatient/day-care settings  

Therapeutic Drug MonitoringTDM of antifungal therapy for the drug voriconazoleQuantification of plasma levels for monitoring and optimization of the therapy  

Special Phase I StudiesEvaluation of pharmacokinetics, -dynamics for IITs/sponsor studiesIn-depth expertise in drug development to increase therapeutic safety 

Translational Trial ConsultingBringing research to the clinic! Clinical pharmacological expertise translational projects of the Heidelberg Campus 

PharmacometricsThe right drug in the right doseSimultaneous modeling of drug concentrations and effects over time 

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