Setting

FIM Heidelberg is a joint venture consisting of the University Medical Center, the Medical Faculty of Heidelberg, and the DKFZ, and is located in the heart of the Heidelberg University Campus and the Rhine-Neckar area (catchment area of 5 million inhabitants).

KliPS

The Clinical Research Unit (KliPS) is integrated in the Department of Internal Medicine of the Heidelberg University Hospital and conducts all study types with healthy volunteers and adult and pediatric patients. KliPS consists of an ambulatory and a stationary area (11 beds), in which study participants can be accommodated for various time periods (shower facilities, dorm rooms and a lounge equipped with cable television, daily newspaper, and internet are available). Purpose-equipped rooms are dedicated to the preparation and storage of study medication and to the processing, storage, and shipment of study samples. All outpatient clinic rooms and all beds are equipped with an intensive care monitoring system (Mortara Surveyor S12) with invasive pressure measurement, continuous digital 12-lead ECG, telemetry etc.. All monitors are linked to a central monitoring room where study data is continuously supervised and stored. KliPS has a well-established quality management system and is certified according to ISO 9001:2015.

NCT

Similar to the model of American Comprehensive Cancer Centers, the Heidelberg National Center for Tumor Diseases consolidates patient care, cancer research, and cancer prevention. The NCT is a cooperation project of the Heidelberg University Medical Center, the German Cancer Research Center (DKFZ), the Heidelberg Thoracic Clinic (Thoraxklinik), the Heidelberg Orthopedic University Hospital, and the German Cancer Aid. An interdisciplinary tumor outpatient clinic is the central gateway for all adult and pediatric oncological patients of the NCT. The NCT performs tumor diagnostics. All patients are treated according to international standards and to the recommendations of dedicated tumor boards consulted for every patient. New scientific information is transferred into diagnostics, therapy, and the prevention of cancer. A substantial fraction of all patients participates in clinical trials which are supported by a study center, a clinical studies.

KKS Heidelberg

The Coordination Center for Clinical Trials (KKS) was established by the Medical Faculty of the Heidelberg University to support clinical trials and efficiently improve the quality of clinical studies. The KKS ensures the compliance with applicable guidelines and laws during the entire study period thus guaranteeing an internationally competitive quality level. The KKS is divided into different areas of responsibility, such as (scientific) project coordination, clinical monitoring, and pharmacovigilance. Biometrics and data management processes are carried out in close cooperation with the Heidelberg Institute of Medical Biometrics and Informatics (IMBI). Data acquisition is supported by a validated RDE (remote data entry) system.