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