Traceable back to the data
Every fact in a narrative — dates, doses, lab values — is checked against the safety database directly, not copied from a prior draft, so nothing drifts from what actually happened in the study.
What's included
What goes into each narrative
- Case identification against the safety database for every death, SAE, and study discontinuation meeting narrative criteria
- A structured narrative covering relevant history, event onset, treatment, and outcome for each case
- Dates, doses, and event terms cross-checked against the safety database and coded terminology before drafting
- Consistent narrative format applied across all cases in the study, ready for CSR appendices
- Medical review of causality language and terminology before the narrative is finalized
- Narratives delivered in step with the CSR full writing timeline
Consistent voice across every case
One team drafts every narrative in the study, so terminology and structure stay consistent whether the CSR carries five cases or fifty, and pairs cleanly with lay summary development when a plain-language version is also needed.