• Writing of documents in the electronic common technical document (eCTD) format including clinical summaries and clinical overviews
  • Responses to questions from authorities
  • Writing of clinical study reports (CSRs)
  • Writing/co-authoring of:
    • Statistical Analyses Plans (SAPs) for pooled analyses
    • Briefing Books
    • Investigational Brochures (IBs)
    • Orphan drug designation applications
    • Risk Management Plans (RMPs)
    • Summaries of Product Characteristics (SmPCs)
    • Paediatric Investigation Plans (PIPs)