Value chain — stage 07
Pharmacovigilance & safety
Case intake, coding, narratives, literature screening, signal detection and aggregate reports — the highest-volume regulated text work in the industry.
- ICSR intake & case processing
- MedDRA coding & narratives
- Literature monitoring
- Signal detection
- Aggregate reporting
In depth
3 articles
Specific problems, specific answers, each written against a named source and dated.
Case study: The Triage Layer a Biotech Put in Front of Its Safety Database
A 2017 triage layer in front of Argus, read against the reporting clocks it cannot move and today's AI intake.
Safety · 11 min readEvery Marketing Authorisation Holder Now Owes a EudraVigilance Signal Duty
The pilot list ended, the notification form disappeared, and most signal management procedures describe a regime that no longer exists.
Safety · 14 min readEMA Now Emails Your QPPV a Monthly List of Late Cases
How compliance is computed, which reports are excluded, the timezone trap, and why inspectors already hold exactly the same data.
Safety · 13 min read