Fraunhofer ITEM: Services in Respiratory Clinical Trials


  • Scientific consulting
  • Identifying appropriate proof-of-concept models and study designs for trials
  • Developing study protocols
  • Clinical conduct of trials
  • Patient information and informed consent forms (ICFs)
  • Submitting requests for ethical review of mono-center trials
  • Recruiting patients and healthy volunteers
  • Updating and archiving trial-related documents
  • Process monitoring by a separate quality control department