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Phase I Services - Medical Writing


BCI’s medical writing consultants will either develop or assist the client in developing clear, concise documents that are scientifically / medically accurate and fully compliant with regulatory requirements. BCI can assist with global IND or clinical trial applications and other regulatory submissions such as:

  • Global clinical trial applications
  • Drug, device and biologics marketing applications
  • Preclinical and scientific reports
  • Investigator brochures
  • Premarketing and post-approval annual reports
  • Phase I-IV protocols and integrated clinical statistical reports (ICSR)

BCI’s medical writing consultants are experienced in the preparation of :

  • Clinical development plans
  • Protocols
  • Clinical study reports
  • Clinical sections of Common Technical Documents (CTDs)
  • Clinical sections of New Drug Applications (NDAs)
  • Investigator brochures and annual updates
  • Pharmacovigilance documents
  • Pre-FDA meeting briefing documents
  • Preclinical study reports, expert reports, and summaries
  • Written and tabular summaries
  • Benefit/risk assessment reports