Medical Writing

RPI, a globally trusted eCTD vendor, provides technical and medical writing and editing services for regulatory submissions in eCTD format. Example eCTD Submission documents include:

  • Study protocols and amendments
  • Investigator’s Brochures
  • Clinical study reports
  • Patient narratives (safety and efficacy)
  • Module 2 summaries (quality, nonclinical, and clinical)
  • Integrated summaries of safety and efficacy (ISSs and ISEs)
  • Development and management of document timelines
  • Nonclinical reports (i.e. pharmacokinetic and pharmacodynamics)
  • Scientific manuscripts for publications
  • White papers
  • Pre-meeting briefing documents
  • Product labeling
  • SOPs
  • Press releases

Clinical Science expertise and activities include:

  • Expert and insightful interpretation of clinical data and statistical results and integration of results within studies (PK, PD, efficacy and safety) enabling better understanding of the therapeutic issues and more effective regulatory interactions
  • Review and editing of SAPs (Statistical Analysis Plans) and TFLs (Tables, Figures, and Listings)
  • Developing clinical study designs and plans in conjunction with study statisticians and clinical operations
  • Clinical science-perspective on protocols and clinical development plans (i.e. integration and balancing of clinical and statistical significance)
  • Communication and coordination of issues between statistical/programming, clinical, regulatory, and other relevant functional areas

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