Zum Inhalt springen
Post-Authorization Clinical Studies (Phase IV), Safety Studies (PASS), Efficacy Studies (PAES) and Observational Studies (NIS)
- Project management
- Literature search
- Analysis of data gaps
- Scientific reviews
- Transition of research ideas to precise study designs
- Preparation of study protocols
- Preparation and submission of study documents for government agencies and ethics committees
- Preparation of clinical research forms and case report forms
- Preparation of clinical study reports
- Submission and registration of study results to government agencies and ethics committees
- Publication and presentation of study results (DE/EN)
- Support preparation of governmental required plans and reports for medication, medical devices and in-vitro-diagnostics
Non-animal basic and pre-clinical research
Consulting – Management -Training – SETUP
Cell-based model testings <<< & >>> IT-based simulation models
- Scientific investigation on specific testings
- Preparation of study protocols and designs
- Vendor selection and qualification (laboratories specialized on non-animal testings)
- Management, monitoring, quality assurance
- Data hosting (vendor)
- Statistical analysis
- Preparation of publication and presentation of study results
