Informations for Sponsors
The Center for Clinical Studies Borstel has three main focuses: translational research, diagnostic or biomolecular investigations on clinical biomaterials and trials according to German Medicine Act (Arzneimittelgesetz, AMG) on therapeutic compounds (phases I - IV). On the on hand, the laboratory infrastructure in Borstel facilitates rapid access to clinical and research laboratories on the campus. On the other hand, our close proximity to the hospital wards and the outpatient department of the “Medizinische Klinik” allows easy recruitment of ambulatory and bed-bound patients for clinical research. Based on this closely woven connection between basic research, laboratories and patient management, we can offer a wide spectrum of resources and options that can be used for scientific purposes. More details about our facilities and staff can be found here. Subsequently, we offer a wide range of services: planning, layout and conduct of Investigator Initiated Trials, conceptual design of study protocols, consultant services for sponsors, CRO / SMO services for sponsors of industry driven projects, etc. Please visit the following sites for further details.
Know-how
Pre-study
- Conceptual design of clinical trials
- Statistical estimations
- Budget calculations
- Creation of study protocols
- CRF design
- Communication with the Ethics Committee
During the study
- Conduct of clinical trials according to ICH-GCP
- Screening and recruiting of participants
- Professional data acquisition and documentation
- Serious Adverse Events (SAE) and Unexpected Adverse Events (UAE) Management
- Cooperation and support for external monitors and CRAs
Post-study
- Data storage
- Statistical analysis
- Writing of reports
- Support and consultant services for publications