The in-house ward is equipped to host subjects under standardized conditions in the context of clinical trials such as PK-, BE-, DDI studies. In addition, the outpatient unit as well is designed to manage clinical assessments and subject monitoring in the context of ambulatory trials.
There are several function rooms, which are used for clinical investigations:
examination rooms, blood sampling rooms, laboratories for preparation and basic analysis of several biological matrices (e.g. blood, urine, sputum). Furthermore a dedicated room for various clinical assessments (e.g. ECG, blood pressure and pulmonary function tests incl. body plethysmography and spirometry) is available. The function rooms are partially air-conditioned.
The continuous monitoring of safety parameters (e.g. pulse rate, 3-lead ECG, oxygen saturation in peripheral blood) in combination with an alarm system and storage of data is nowadays mandatory for certain studies in early clinical development, e.g., First-in-Man (FIM) trials. Inamed is always committed to the highest quality standards in clinical research, and that is why Inamed has now refurbished its in-house 6-bed Intensive Monitoring Unit which is part of Inamed’s in-patient ward dedicated to the conduct of clinical studies (for further information see below). Inamed’s Intensive Monitoring Unit comprises 6 measuring stations that are equipped with modern Draeger Monitors and peripheral devices which allow the monitoring and recording of all well-established, non-invasive vital parameters. In addition to the bed-site monitors, all safety information is simultaneously displayed on a central monitor by using a modern telemetric system. Alert ranges for the different safety parameters can be individually selected according to the requirements of a certain study.