In the case of Serious Adverse Events (SAEs) and/or Serious Unexpected Adverse Events, MRC’s team of nurses can supplement the data captured in MedWatch forms with SAE Narrative Writing. MRC’s SAE Narrative Writing includes:
- In-depth medical record review
- Summarization and highlight of relevant clinical information
- Concise and comprehensive narrative report presented in chronological sequence
- Report submission directly to the FDA on client’s behalf, or delivered to clients in their preferred formats
- Assigned nurse staff who possess significant critical care experience and knowledge across a wide variety of clinical specialities
