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Wordsmith Medical Writing is committed to providing high quality support and expertise to those who need a helping hand during the drug development process.

Medical Writing

  • Preparation of clinical regulatory documents at the study level, across a development program, and for submissions (eCTD modules); examples include:
  • Protocols and amendments
  • Clinical study reports
  • Patient safety narratives
  • Investigator's Brochures and updates
  • Development Safety Update Reports
  • Module 2 summaries
  • Regulatory health authority or ethics committee responses and communications
  • Management of the document development process from start to finish
  • Submission planning and oversight

Quality Control and Technical Editing

  • Full and partial review of both clinical and non-clinical regulatory documents
  • Components can include checks for the following:
  • Source verification for text and data
  • Inter- and intra-document consistency
  • Editorial review and style guide compliance
  • Alignment with templates
  • Abbreviations
  • References

Formatting

  • Application of formatting templates and styles
  • Alignment with specified formatting standards
  • Visual and technical inspection of content and attributes
  • Preparing for appropriate conversion to PDF

Publishing

  • Document-level publishing of clinical and non-clinical regulatory documents
  • Alignment with eCTD-compliant standards
  • Ensuring appropriate conversion to PDF
  • Submission-readiness quality control review

Consulting

  • Recommendations for and implementation of structures, standards, and processes
  • Training and instructional resources
  • Creation and/or maintenance of the following:
  • Style guides and conventions documents
  • Templates
  • Standard operating procedures
  • Best practices, work instructions, and job aids
  • Abbreviations
  • References
  • Other projects as requested

Software Development

  • Creative technology solutions engineering
  • Development of custom software (e.g., formatting toolbars, template add-ins)
  • Creation of associated instructional documentation
  • Implementation planning and training
Wordsmith Medical writing

Careless writing makes people doubt the science behind it.

Wordsmith Medical Writing is committed to providing high quality support and expertise to those who need a helping hand during the drug development process.
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