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Medical Writing

We have superb medical and statistical writers who have received great positive feedback from sponsors and from the FDA. 

  • Clinical study reports
    • We can follow ICH guidance, if desired
    • We can follow your template, if desired
    • We can prepare a brief report or a detailed report, as you wish
  • Abbreviated study reports
    • For seriously flawed or aborted studies
    • For studies that are not pivotal
    • For studies that are not of primary interest
    • Backlog studies
    • Studies in other indications
    • Marketing studies
    • Safety studies
  • Planning documents
  • Focus reports or specialty reports
  • Position papers
  • Manuscripts
  • Articles
  • Statistical Analysis Plans (working with statisticians - ours or yours)
  • Mock Tables (working with statisticians - ours or yours)
  • Tables Manuals (working with data managers, programmers, and statisticians - ours or yours)
  • Presentations in Power Point
  • Instructions for completing case report forms
  • Coding Manuals (working with data managers - ours or yours)
  • Data Validation Manuals (working with data managers - ours or yours)

 

 

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