We work "exclusively" in accordance with internationally established standards
It includes:
- study protocol preparation
- CRF/CIB design
- selection and recruitment of investigational sites
- organisation of clinical investigator meetings
- inhouse CRA-training
- monitoring, quality control and audits
- communication with the ethical review boards/regulatory authorities
- support for patent applications
Data management
- statistical trial planning including CRF preparation
- randomisation
- design of data structures/data entry masks
- double data entry
- query management
- efficacy evaluation
- biometrical consulting
Medical Writing
- integrated study reports according to ICH/Sponsor SOP
- investigator brochures, publications, lectures and posters
- analysis of trials, writing of final reports and clinical expert reports
- presentation of trial results at international congresses and events
- publishing of trial results in highly respected international peer-reviewed journals
We are directly associated with several investigator networks (GPs, diabetologists, endocrinologists) and in possess of one of the most efficient CRO networks in Europe. Furthermore, we offer the performance of clinical trials in collaboration with our inhouse principal investigator and clinic.
