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Clinical Research Unit (KliPS)

Mikus
 
 
 
 
 

 

The Clinical Research Unit is specialized in planning and conducting clinical trials of early phases 0 and I including first-in-human trials. With its specialized infrastructure, the legal, ethical, and technical framework reproducible data of highest quality are generated and the safety of the study participants in strict accordance with all ethical and legal conditions is ensured. KliPS plays an important role in transferring new substances from the pharmaceutical industry and also from academic sites resulting from translational research into clinical phases efficiently and safely. 

 

 

Staff 

Head:Prof. Gerd Mikus, MD, MSc
Scientific Staff:

Antje Blank, MD
Dr. med. Andrea Huppertz
Mazyar Mahmoudi
Peter Rose
Dr. Anja Williams

Practical Year:Julia Salvatore

Study Coordinator:            

Marlies Stützle-Schnetz, MSc

Study Nurse:Marlen Dettmer
Anna-Lena Dierlich
Katharina Hilse
Petra Hüholt
Katja Käss
Florian Michel
Sophie Sherman
Brigitte Tayrouz
Doctoral Students:

Philipp Baumgärtner, cand. med
Yoana Aurelia Djaelani, cand. med.
Annika Elbe
Christian Ott, cand. med.
Marlene Schaumäker, cand. med.
Lars Werntz, cand. med.
Helen Wu, cand. med.
Vanessa Zhu

Services

Clinical trials phase 0, I and II

If you are looking for a competent partner for conducting your clinical trials we are happy to make you an offer. Please complete  the application form ‚Clinical Drug Trials’ and send it via e-mail or fax to Prof. Dr. Mikus (for contact details please see form).

Projects / Research Focus

  • Development, validation and application of new models for phenotyping
  • Inhibition and induction of  CYP3A4 with midazolam as a marker
  • Oncological phase I and II-trials in patients with breast, esophagus, gastric, hepatic, colon and pancreatic carcinoma
  • First-in-man trials (Opens external link in new windowFIM) with volunteers and patients

Methods and Equipment

The Study Center KliPS is located in the Department of Internal Medicine of the Heidelberg University Hospital. Study participants can be accommodated on the ward (12 beds) for several days or weeks (shower facilities, dorm rooms and a lounge equipped with cable television, daily newspaper, and internet are available). Special rooms are designated for the preparation and storage of study medication, and for processing and storing samples.

Outpatient clinic rooms and all beds are equipped with an intensive care monitoring system (Mortara Surveyor S12 with non-invasive blood pressure measurement, continuous digital 12-lead ECG, telemetry, etc.). All monitors are linked up to a central monitor where data are continuously supervised and stored. The computers at KliPS are equipped with the integrated clinical data capture and data management software Promasys®. KliPS has a well-established quality management system and is certified according to ISO 9001:2008.

Cooperations

  • Koordinierungszentrum für Klinische Studien Heidelberg (KKS)
  • Institut für Rechtsmedizin, Universität Heidelberg
  • Abteilungen der Medizinischen Klinik (Krehl-Klinik), Universität Heidelberg
  • Nationales Centrum für Tumorerkrankungen (NCT)
  • Hautklinik, UniversitätsKlinikum Heidelberg 
  • Universitäts Frauenklinik, UniversitätsKlinikum Heidelberg
  • CRS Andernach
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