MEDICAL WRITING

Medical Writers at Exom Group are professionally qualified in combining medicine, science, writing skills and simplicity to deliver concise documents for all stages of a clinical trial, supporting regulatory submission, project management, up to the final report.

OUR SERVICES

  • Trial synopses, protocols and amendments
  • Patient information sheets & informed consent forms
  • Case report form (CRF) design
  • Patient questionnaires & diaries
  • Standard operating procedures (SOPs )
  • Integrated Summary of Safety (ISS) reports
  • Non-clinical pharmacology and toxicology reports
  • Integrated clinical trial reports (ICH E3) / interim reports
  • Case Narratives
  • Abstracts & Manuscripts
  • Newsletters, advertisements for clinical studies
  • Documentation for congress exhibits
  • Investigator’s Brochure integrations(IBs)
  • Data safety monitoring board (DSMB) manuals
  • Written and tabular summaries
  • Benefit/risk assessment reports
  • Medical and scientific literature reviews
  • Investigational Medicinal Product Dossiers (IMPDs)
  • Investigational New Drug documents (INDs)
  • Paediatric Investigation Plans (PIPs)e
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