The Centre for Clinical Trials Regensburg
The Center for Clinical Studies (ZKS) at the University Hospital Regensburg – the most recent University hospital in Germany – was established proactively without public funding.
The ZKS Regensburg cooperates with all departments of the University Hospital Regensburg. The high number of 200 newly registered clinical studies per year shows the commitment of the University Hospital Regensburg to clinical research. As a service provider and research partner, the ZKS Regensburg supports clinicians in all aspects of clinical studies, from design to registration, implementation, analysis, and publication.
The ZKS Regensburg supports about 100 research projects and approximately 50 publications every year.
The ZKS Regensburg serves as the central registration office for clinical studies according to the guidelines for third-party funding of the University Hospital Regensburg. In addition, the ZKS Regensburg is the contact office for external partners from industry, pension and insurance providers as well as study groups who wish to investigate new drugs or therapies in clinical studies. All members of staff of the ZKS Regensburg are highly qualified and take part in specialized training programs on a regular basis.
The ZKS Regensburg has been a full member of the Network of the Coordination Centers for Clinical Trials (KKS Network) since 2011 and is certified according to ISO 9001:201.
Key activities of the ZKS Regensburg are:
- Planning and designing clinical studies
- Biometrics and biostatistics
- Data management
- Study coordination and study assistance
- Quality management
- Medical editing and translation
- Training courses on the Medical Products Act and the Medical Devices Act (basic, advanced and refresher courses as well as updates), dangerous goods training courses, and 3-week training courses for study assistants.
Together with cooperating partners at the University Hospital Regensburg, further services in the fields of regulatory affairs, project management, clinical monitoring and pharmaco-vigilance can be provided.
A further important task of the ZKS Regensburg is to support the emerging Comprehensive Cancer Centre of Eastern Bavaria as well as the implementation of an Early Clinical Trial Unit.
The ZKS Regensburg has particular methodological expertise in outcome assessment, healthcare research, and the development of clinical practice guidelines.