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Clinical trials

Project preparation

Study protocol, CRF, informed consent, patient information

  • Development of documents up to final layout
  • Review / audit of external trial documents
  • CRF artwork, production planning and supervision of printing

Ethics committee procedure / authorities

  • Preparation and submission of documents to ethics committees and
    competent authorities
  • Preparation of additional, country-specific formalities
  • Processing of comments
  • Processing of amendments
  • Reporting procedure to local authorities
  • Ensuring the duty to inform (e.g. SUSARs, amendments)

Study medication, lab, measurement devices

  • Randomisation procedure, emergency envelopes
  • Planning and organisation of central lab
  • Demand planning and packing of lab material and measurement devices
  • Planning and organisation of medication shipments