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Scope
- ISO 9001:2015 certified Early Clinical Trial Unit for GCP-compliant conduct of first-in-human trials and early phase clinical trials.
- 12 beds, 3 day hospital beds, and 2 outpatient rooms
- Intermediate care setting and monitoring, 24h/7d
- Connection to emergency and intensive care structures of the Medical Clinic
- Comprehensive diagnostic capabilities of a maximum care university hospital
- Effective recruitment of patients and healthy volunteers for inpatient, day-care and outpatient trials in cooperation with various partners of the Heidelberg University Hospital.
- Established processes for conducting clinical studies as cooperation projects
- Transparent separation of clinical trials measures from daily clinical routine, based on an excellent collaboration with standard hospital care
- One-stop comprehensive trial organization and processing, in close cooperation with other hospital departments
- Standardized, GCP-compliant conduct generates highest quality trial data
- Biomarker processing and drug quantification in the department's laboratories Molecular Biology-Biochemistry Laboratory and Analytical Chemistry Laboratory
Mission
Through competent planning, proven expertise and high commitment regarding the conduct of clinical trials, we create safety for both healthy volunteers and trial patients and ensure valid results.
Background
Conduct of more than 120 clinical trials according to German Medicinal Products Act (AMG) since 2008, including more than 25 first-in-human trials with small molecules, biologicals, vaccines (therapeutic, preventive, protein, RNA, vectors).
