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