STUDY MANAGEMENT

Our team of international scientists develops tailor tailor-made solutions for you according to your requirements to ensure the success of national and international clinical and technical studies:

  • Study preparation incl. literature research for the clinical evaluation of IVD/Medical Devices
  • Risk-based planning and monitoring of all processes in all project phases
  • Medical writing, selection of suitable study sites
  • Contracting, creation of Case Report Forms (CRFs), Patient Information and Informed Consent
  • Compilation of the documentation, application and submission to the competent national and international authorities (CA) and ethics commitees
  • Coordination of the monitoring process, data management and data analysis
  • Regulatory and organisation of the scientific advice of CA and notified bodies
  • Biostatistics
  • Support during the CE-certification of your products (both in the EU and the US (510(k)-Clearance))
  • Post Market Clinical Follow-up (PMCF)