Clinical Development & Research Documents

Clinical Development & Research Documents

We create, review, and/or update…

  • Research protocols and amendments
  • Informed consent forms
  • Investigators brochures (IB)
  • Summary of changes documents
  • Investigational medicinal product dossiers (IMPDs)
  • Patient information leaflets
  • Clinical study reports (full, abbreviated, interim, and synoptic)
  • Patient-level and event-level safety narratives
  • Annotated bibliographies