Carolina Medical Writers, LLC, provides regulatory writing services for pharmaceutical companies, biotechnology companies, and clinical research organizations (CROs). We bring a wealth of medical writing experience to your program. Carolina Medical Writers  is adept at working with client report templates and style guidelines or can use our own established templates and standards. In either case, we are committed to the details that help ensure your finished document is of the highest quality.

We are pleased to offer medical writing, editing, and quality-review services for the following documents:

  • Clinical Study Reports (Phases I-IV)
  • Investigator Brochures
  • Investigational New Drug (IND) Annual Reports
  • Study Protocols
  • Informed Consent Forms (ICFs)
  • Patient Narratives
      • Serious Adverse Events (SAEs)
      • Adverse Events (AEs) Leading to Withdrawal
      • Other Significant AEs
  • Additional Portions of the Common Technical Document (CTD)
  • Standard Operating Procedures (SOPs)
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