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MEDICAL WRITING
Trio works with a network of experienced independent medical writers who are industry trained. Through this network, Trio can provide a writer experienced in the preparation of almost any clinical document type for inclusion in IND and CTD submissions or for other regulatory use required for a clinical study including: |
- Protocols and amendments
- Clinical study reports – full and abbreviated reports and synopses
- Clinical pharmacology study reports - full and abbreviated reports and synopses
- Investigator’s Brochure/Product Monographs, other product/drug information
- Summary submission documents - safety (ISS, Safety Report), efficacy (ISE), pharmacology; toxicology
- Clinical Overview for a CTD
- Health outcomes reports
- IND annual reports
- NDA annual reports
- 4-month NDA/CTD US submission updates
- Summary documents for interim reviews
- Narratives for deaths, other serious adverse events, and certain other significant adverse events
- End of Phase briefing documents
- Package labeling; subject/patient labeling
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