Regulatory documents

  • Clinical trial reports, Phase I-IV
    (ICH 3 or company specific SOPs)
  • CTD:
    Clinical and non-clinical summaries, clinical overviews
  • Integrated summaries
  • Observational study reports
  • Patient survey reports
  • Periodic Safety Update Reports (PSUR)
  • Study protocols
  • Synopses

Other documents according to your needs.