Services

• Advice on study conception, study design, regulatory classification, sponsor obligations, funding and cost calculation, statistical advice in collaboration with Biometrie Ulm, review of the study protocol/trial protocol and study documents
• Advice and support for research applications
• Compliance check (sponsor assurance) to recommend sponsor acceptance by the UKU, mandatory for studies with medicinal products, medical devices and publicly funded studies in accordance with professional regulations
• Risk-based quality management (RbQM) in clinical trials according to GCP

The ZKS Ulm supports you in the following areas