Premises
The Phase I Unit is equipped with everything it needs to conduct trials in a professional and standardized way. It has a total of ten fully monitored bedswith one three-bed room, four two-bed rooms and one single bed room, and is suitable for all kinds of clinical trial that require long-term inpatient observation or simply outpatient care. The ward can be access-controlled if required.
There are also rooms for screening examinations, processing biological samples, preparing investigational medicinal products (IMPs) and storing samples and IMPs in a temperature-controlled environment, a a central base for monitoring subjects and offices for documentation, recruitment and, monitoring. With a common room, internet connection and bedside TVs, the ward also provides a comfortable atmosphere for subjects taking part in the trials. The pharmacy, the central laboratory, the research laboratories, the BioBank and the Clinical Study Core Unit of the Study Center Bonn are all situated in direct neighbourhood of the Phase I Unit.
Monitoring
The beds on the ward are equipped with monitors for the continuous recording and long-term storage of 12-lead electrocardiogram (ECG), pulse oximetry, blood pressure and body temperature. Using telemetry to capture ECG data enables mobile long-term recording.
Preparation of samples and storage
Freezers (-80/-20°C), refrigerators and cabinets at room temperature can be used to store biological samples and IMPs. These can be locked, are located in air-conditioned, access-controlled rooms and have their temperature monitored centrally 24/7 so that action can be taken immediately in the event of deviations from the temperature specifications.