Preeti Verma/LinkedIn

Aug 16, 2026, 14:27

Preeti Verma: The Case of the Missing Clue – Why Databases Need a Clinician’s Eye

Preeti Verma, Associate Vice President of Qinecsa Solutions, shared a post on LinkedIn:

“The Case of the Missing Clue: Why Databases Need a Clinician’s Eye

An Individual Case Safety Report (ICSR) arrives in the PV database:

An automated system logs the event, codes the terms, and moves on.

But as a former gynaecologist, my clinical alarms go off.

I start looking for what isn’t there:

The Obstetric Context: Is she postpartum? Could she be in early undetected pregnancy? Both can significantly alter the baseline risk of thrombosis.
The Genetic Risk: Is there an undocumented family history of Factor V Leiden or other thrombophilias?
The Lifestyle and Clinical Context: Was she on a long-haul flight? Had she recently undergone surgery? Was she immobilised for another reason?

A PV safety database will see a drug – event pair.

A clinician sees a complex patient history waiting to be uncovered.

Without targeted follow-up questions to fill these critical gaps, our understanding of causality and clinical relevance may remain incomplete.

Data processing handles the ‘what.’

Clinical experience helps uncover the ‘why.’

PV peers, what is the one predisposing factor you find most frequently missing from your ICSRs?”