Our CPU is equipped with a central surveillance system, which has been established together with Siemens on the basis of Elpro measuring devices. Suppliers are qualified within our Quality Management System; software is validated following the requirements of US CFR 21 Part 11.
Freezers, refrigerators and the IMP storage area including safes for the storage of opioids are under continuous surveillance and allow tracking of all critical steps.
Alarm runs on a 24/7 external emergency phone with qualified and trained background service for immediate intervention and a pre-specified emergency scenario.
Emergency calls run on the same central Siemens-based surveillance system and initiate a pre-specified emergency cascade documenting the call as well as the response. Emergencies are escalated via loudspeakers with specified and localised announcement as well as via internal emergency phones.
Our intensive assessment station is equipped with a total of 6 beds with cardiovascular surveillance specifically designed for first-in-human studies with an MTD approach and other studies requiring a high-security level .
If a standardised temperature is necessary, e.g. for certain pharmacodynamic interventions, all relevant areas are air-conditioned.