What's included

What goes into the CSR

• Full CSR text drafted to ICH E3 structure, section by section, from the shell built during conduct
• Narrative built directly around the tables, listings, and figures generated by our biostatistics team, not reconciled after the fact
• Safety sections aligned with pharmacovigilance and cross-checked against patient narratives and SAE listings
• Consistency review against the investigator brochure and other regulatory documents referencing the same study
• Cross-functional QC pass before the report moves to sponsor review and submission