STUDY MANAGEMENT
Our international team develops tailor-made solutions according to your requirements to ensure the success of national and international clinical and analytical performance studies:
- Study design, incl. literature search
- Study preparation
- Risk-based planning and monitoring of the processes in all project phases
- Creation of performance study plans, selection of suitable clinical sites
- Statistical consultation, including sample/subject size planning
- Preparation of investigator contracts, preparation of Case Report Forms (CRFs), and Informed Consent
- Compilation of the documentation, application and submission to the responsible national and international authorities and ethics committees
- Cross-functional coordination of the study team
- Organization of scientific advice
- Preparation of the study report
