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 beds, spread across one three-bed room, four two-bed rooms and one single room, and is suitable for all kinds of clinical trial that require more than just short-term inpatient observation or outpatient care. The ward can be access-controlled if required.
There are also rooms for conducting screening examinations, processing samples, preparing investigational medicinal products (IMPs) and storing samples and IMPs in a temperature-controlled environment as well as a support center for monitoring subjects and offices for documents, recruitment, monitoring and other uses. 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 central trial office of the Bonn Trial Center are all right next to the Phase I Unit.
Monitoring
The beds on the ward are equipped with monitors for the continuous logging and long-term storage of 12-lead electrocardiogram (ECG), pulse oximetry, blood pressure and body temperature data. Using telemetry to capture ECG data enables mobile long-term recording.
Preparation of samples and storage
Freezers (-80/-20°C), refrigerators and cupboards 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 around the clock so that action can be taken immediately in the event of deviations from the temperature specifications.
