We handle the planning and management of clinical trials for pharmaceuticals and medical devices across all phases and risk categories, including commercial and non-commercial (IIT) trials, as well as non-interventional studies (NIS: AWB, RWE, registry studies, cohort studies, etc.):
- Project-setup and coordination
- Project management, budget planning, contract preparation
- Selection of suitable study sites
- Creation and maintenance of the Trial Master File
- Planning, organization and conduct of expert meetings
- Investigator compensation in accordance with german law
- Material shipping
- Organization of central readings
- Detailed interim reports to ensure sponsor oversight
- Medical documentation at sites
- Other services such as: information officers (§74a), safety assessments
