Clear, compliant safety narratives that tell each patient's story
Patient narratives provide the clinical context that safety data alone cannot convey. These documents help health authority reviewers understand individual patient experiences, assess causality, and evaluate the overall safety profile of your product. Well-written narratives present complex medical histories clearly while maintaining strict adherence to regulatory requirements.
Comprehensive narratives for serious adverse events including hospitalizations, life-threatening events, and events resulting in significant disability. We present the timeline clearly to support causality assessment.
Detailed narratives for fatal events requiring thorough documentation of the clinical course leading to death. We compile information from case report forms, autopsy reports, and investigator assessments.
Documentation of early study discontinuations due to adverse events. These narratives capture the reasons for discontinuation and subsequent patient outcomes.
Documentation of significant protocol deviations that may impact data interpretation. We present the deviation, its potential impact, and any corrective actions taken.
Consistent format across narratives for efficient review by health authorities.
All data points traced to source documents for accuracy and traceability.
Review by medically trained writers ensures clinical precision.
Adherence to ICH E3 and regional requirements.
Ability to handle high volumes under tight timelines.
Our narratives include all required elements per ICH E3 guidance:
Standard narratives can typically be completed within 3-5 business days of receiving complete source data. For high-volume programs, we work with your team to establish batch schedules.
We flag missing data elements and work with your clinical team to obtain necessary information. When data gaps cannot be filled, we document them appropriately in the narrative.
Yes. We can develop narratives on a rolling basis as events occur, or compile all narratives at study completion.
Contact ESW Communications to discuss your requirements.
Contact Us Today