Medical Affairs & Writing

Our medical, regulatory, and scientific affairs teams provide advice and documents for all stages of product development. Our team of industry professionals has expertise in multiple therapeutic areas and is familiar with a wide variety of writing formats and styles. Working with fully ICH compliant templates or with your own templates, we can provide writing support as part of a full-service contract or as individual writing projects.

Clinipace Worldwide writing services support all service lines including regulatory, clinical development, medical communications, pharmacovigilence, and post-approval programs; and include the following deliverables:

  • Agency Meeting Briefings
  • Analytical Validation Reports
  • Clinical Protocols and SOPs
  • Clinical Study Reports
  • CMC Documents, including QOS
  • DSMB reports
  • Environmental Assessments
  • Expert Reports/Clinical Overviews
  • Informed Consent Documents
  • Investigator Brochures
  • IRB communications
  • Literature Summaries
  • Patient Information Brochures
  • Product Monographs
  • Reporting to Health Authorities
  • Scientific Abstracts, Manuscripts, Posters, Conference Reports
  • Study Protocols
  • Periodic Drug Safety Update Reports (PSUR)