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What an agent could do
Identify possible adverse-event reports and route them for timely human review.
The decision underneath
What may it classify or escalate, and who decides whether a report is complete?
01
Where most ideas start
"Use AI to make drug safety reporting faster."
✕ Too vague
Make it specific
02
A workable use case
We want an agent to identify possible adverse-event reports in study-site messages and incoming safety inquiries, flag missing case details, and route time-sensitive cases to a qualified safety reviewer in time for required assessments and reporting.
Measure it
03
How you'll know it works
If the agent really helps, these numbers should change. Measure them before it goes live, then again after:
Time to first safety review; Cases missing key information; Overdue safety reports
Then decide
04
The decision to make first
May it assign a preliminary case category or request missing information without prior human approval? Who determines reportability and completeness before a case is submitted or closed?
Settle this before the agent goes live, not after.
Your turn
05
Pick a business problem in your organization that is expensive, slow, risky or frustrating. Then work through these four questions, as in the workshop:
1
What business problem are we solving?
2
Who would sponsor this, and why?
3
What measurable business result should change?
4
What would make this difficult to scale here?
Quick test: task or decision?
Is this only a task you want AI to perform, or a business decision you want an agent to help make or execute?