Scientific Posters, Slide Decks, and Abstracts
- Used at scientific conferences to communicate clinical trial data and real-world evidence.
Peer-Reviewed Publications / Manuscripts
- Journal articles based on clinical trials, HEOR studies, or reviews.
Advisory Board Reports
- Summarize insights from external HCPs and key opinion leaders (KOLs).
Clinical study reports (CSRs)
Briefing documents
Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions
Regulatory filings: Clinical sections of IND/CTAs, NDA/BLA/MAAs and other regulatory submissions
Fast track designation, breakthrough therapy, and accelerated approval applications, PRIME assessment and conditional marketing authorization applications