Our state-of-the-art facility provides outstanding medical capabilities. Our CRO owns 35 beds for early phase clinical trials like pharmacokinetic, bioavailability and bioequivalence studies, thereof 10 beds with intensive monitoring capabilities dedicated for First in Human studies, 8 examination rooms, on-site specimen processing lab, biological sample refrigerators and freezers, fully equipped intensive monitoring suite, secure record and drug storage space.
Academic clinical trials are essential for clinical research especially for optimizing patient treatment.
Even though the legal responsibilities, tasks and duties are the same s for conventional clinical trials, IITs are special due to the fact that the financial budgets are in general limited. The peculiarities and difficulties have to be considered, an optimal planning from the very first moment is mandatory in order to perform and finalize them successfully.
Our clinical monitoring group is highly experienced in all monitoring related activities. Our CRAs/Lead CRAs are responsible for and committed to conducting all activities in accordance with the protocol, ICH/GCP/ISO 14155 requirements, the project specific monitoring manual, applicable SOPs and all additional regulatory requirements.
We are located on the campus of the University Medical Center Hamburg Eppendorf (UKE) and this location is one of our greatest advantages in planning, recruiting and conducting clinical trials.
Compliance with this standard ensures public assurance that the rights, safety and well-being of the trial subjects are protected consistent with the principles laid down in the Declaration of Helsinki, and that the clinical data are credible.