Writing Services
Clinical trial-related documents
• Clinical Study Protocols
• Integrated Clinical/Statistical Reports (Phases 1-4)
• Patient Narratives
• Manuscripts
• Abstracts and Posters
• Project-related Newsletters
• Informed Consent Forms
Regulatory Documents
• CTD Summaries of Clinical Safety and Integrated Summaries of Safety (ISS)
• CTD Summaries of Efficacy and Integrated Summaries of Efficacy (ISE)
• CTD Clinical Overview (including Benefit/Risk summary)
• Other CTD components (eg, prescribing information and patient information leaflet)
• NDA 120-day Safety Updates
• Investigational New Drug Applications
• Investigational New Drug Annual Reports
• Investigational Drug Brochures
• FDA Meeting Packages