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Clinical Research Support
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Medical Writing
Medical Writing Information Sheet

DMID-CROMS provides the medical writing services outlined below

  • Protocol and Informed Consent/Assent Documents
    • Development – initial and amendments
    • Template conversion – convert protocol to an appropriate template
    • Distributing for review
    • Collating and incorporating comments
    • Redaction services
    • Quality review – review for consistency of content, conformance with DMID templates, and applicable regulations, guidelines, and DMID policies
  • Investigator Brochures (IBs)
    • Drafting sections and/or entire document
    • Updating with current data
    • Quality review
  • Manual of Procedures (MOPs)
    • Development
    • Collating and incorporating comments
    • Quality review
  • Annual IND Reports and Clinical Study Reports
    • Compiling data into report format per applicable guidelines
    • Drafting sections and/or entire document
    • Writing report synopsis
    • Distributing for review
    • Collating and incorporating comments
    • Finalizing report
  • Manuscripts, Abstracts, and Presentations
    • Assisting in drafting manuscripts, abstracts, and presentations
    • Quality review and compliance with target journal style
    • Developing text and format for effective presentations
  • Statistical Analysis Plan
    • ​​Redaction Services​
  • Other Services
    • Translations – Protocol and protocol-related documents
    • Develop, review/revise protocol-related documents, such as data collection forms and case report form completion guidelines