Medical Writing

High-quality medical writing is integral to successful clinical research, and QST takes pride in the quality of our statistical reports. Our writers work closely with our biostatisticians and data management team to produce clinical reports, specially formatted tables and charts and detailed custom graphics. QST has co-authored the clinical sections of several FDA submissions and has experience producing submission-ready eCTDs.

Medical Writing Services
  • Protocol development
  • ICH compliant clinical study reports (CSR)
  • Abbreviated clinical study reports (CSR)
  • Statistical summaries
  • SAE narratives
  • ISS/ISE services (Integrated summaries of safety and efficacy)
  • Clinical sections for all FDA-submission documents (e.g., Module 2 and Module 5 documents)
  • Journal publications (e.g., abstracts, manuscripts)
  • Scientific presentations/Poster presentations
  • Preparation of End of Phase II and pre-NDA briefing packets
  • Package inserts
  • eCTD