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Catch serious drug side-effect reports, even when they sound mild

Side-effect reports say "mild" or "severe", and neither tells you whether the case is serious under the rules. This app reads each report, decides whether a seriousness rule was met and flags the urgent ones for a case processor.

For drug safety case intakeCross-domain · Pharma & Life Sciences

Why it matters

Today's manual process, and the same job with the app

A drug safety team at a drug maker, sorting incoming side-effect reports before a case processor works them.

✕Today's manual process

1Read every report to find the drug, the patient's age, the outcome and who reported it.
2Check each outcome against the seriousness rules, looking past words like mild or severe.
3Note the reporter's view on whether the drug caused it, then decide which cases go first.
4One slip means a serious case waits in the ordinary queue.
Every report read and judged manually

✓With the app

1Each report is read, and ten details are filled in from it.
2Seriousness is decided against the rules, not the report's own words like mild.
3The reporter's view is kept separate, and serious cases they link to the drug are flagged.
4Flagged cases reach a case processor first. A person still works and files every case.
People start with the urgent cases

See it work

One real case, read by the app, step by step

A consumer reports mild stomach pain in a child taking Orbadanil, with no hospital stay, yet the story describes a life-threatening episode.

Catch serious drug side-effect reports, even when they sound mildReference appBuilt to be shaped to your process
  1. 1The case report AE-0011: a child taking Orbadanil, reported by a consumer.
  2. 2The report's own word mild, the word most readers would go by.
  3. 3What does not count no hospital stay and a full recovery do not rule the case out.
  4. 4Serious under the rules a seriousness rule was met, whatever the report's wording.
  5. 5Sent to a case processor first serious, and the reporter says the drug possibly caused it.

For engineers

How it is built, and how we measured it

All fourteen steps of the build are written up, from the business case to running it in your own environment.

Kit overview →
15 of 15urgent cases flagged for reviewmeasured in 06 Evals →
53 of 55reports judged serious or not correctlymeasured in 06 Evals →
548 of 550report details read exactly rightmeasured in 06 Evals →
0.2¢to triage one reportmeasured in 07 Unit cost →

The build, step by step

14 steps

Make it yours

What you see is a reference app. We shape it to how you work.

Every part of it is built to change, and none of it means starting over.

Your rulesYour seriousness criteria, causality terms and what counts as urgent for your team.
Your recordsThe case reports and narratives your intake team already receives.
Your systemsFlagged cases go to the intake queue of your own safety database.
Your screensThe fields, wording and layout your case processors already use.

Want this for your team?

Talk to us

We can run this on your own case reports, with your own seriousness rules, inside your environment.

Talk to us →
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