From literature monitoring to ICSR drafts.
More literature cases per reviewer. Case decisions remain with your team.
Patient 4 of 4 · patient assessment
Should this patient proceed to intake?
Case identity
Eva L. Sullivan, PharmDCorresponding author
Safety information
reported with→
Proposed resultReady for intakeReporter, patient, ceftaroline, and events identified
Confirm patientNeeds review
Patient 444-year-old man · ceftaroline
Source articlePage 4 of 7 · Case 4
Pilot targetUp to 60%
Lower cost per ICSR, measured on your cases.
Agree the acceptance criteria first. Then measure corrections, reviewer time, and cost on the same case set.
Designed to support21 CFR Part 11EU Annex 11ICH E2B(R3)GVP Module VIGAMP 5
What your team can test.
Designed around CIOMS Working Group XIV principles for AI in pharmacovigilance.
- Case output
- Compare the populated fields and narrative with the publication, then test the draft XML against the named regional profile and safety-system configuration.
- Validation
- Agree intended use and acceptance criteria. Review release identity, change control, production monitoring, and the evidence Premise supplies.
- Data handling
- Review data flow, access, retention, subprocessors, model-training terms, the DPA, and the security assessment.
- Audit trail
- Inspect proposed values, source evidence, reviewer actions, configuration versions, timestamps, and approval meaning.
The founders run the pilot.
Siddish and Ashwanth · hello@premise.bioRun a pilot on your cases.
We handle the setup around your current process. Your team reviews the output.