Safety case mgmt · Drug safety officers / PV scientists
CuRE Canary
Pharmacovigilance — case management, MedDRA coding, E2B(R3), and OMOP-native signal detection.
What it does
Pharmacovigilance — case management, MedDRA coding, E2B(R3), and OMOP-native signal detection. One sealed evidence chain from AE source to regulator acknowledgment — the submitted E2B payload and the ACK/MDN live in the same Part 11 envelope as the case.
Key capabilities
- AE case management
- MedDRA coding + AI-drafted case narratives
- E2B(R3) regulatory export
- Signal detection (PRR / ROR / EB05) on OMOP
- EVDAS / eRMR signal-source integration
- Literature monitoring + ICSR-from-literature
- AI-drafted aggregate-report narratives (DSUR/PBRER)
- Cross-app subject safety-context panel
What sets it apart
- One sealed evidence chain from AE source to regulator acknowledgment — the submitted E2B payload and the ACK/MDN live in the same Part 11 envelope as the case.
- EVDAS/eRMR signal management (the EMA obligation live since 12-Feb-2026) and a Cascade code-break that drives the expedited-reporting clock — the safety system and the IRT on one substrate.
- Aggregate reports, RSI/expectedness, WHODrug, live gateways, safety letters, and pharmacoepi signal evaluation run on the same OMOP evidence base.
- Signal detection runs on the same OMOP as analytics — no separate PV warehouse.
- E2B(R3) export and MedDRA coding are first-class, not bolted-on integrations.
Find a safety signal, live
Pick a drug–event pair from a synthetic spontaneous-reporting database, drag the observed co-report count, and watch the disproportionality statistics — PRR, ROR (both with 95% confidence intervals), the chi-square, and DuMouchel's Empirical-Bayes EBGM / EB05 — recompute in your browser, then the pair's triage move between validated, watchlist, and dismissed.
A synthetic spontaneous-reporting database of 60,000 reports across 5 drugs and 7 events.
| Event + | Event − | |
|---|---|---|
| Drug + | a = 288 | b = 1,312 |
| Drug − | c = 1,512 | d = 56,888 |
Drag above the expected count to manufacture disproportionality — watch EB05 shrink low counts back toward the null.
EB05 ≥ 2.0 and ≥ 3 co-reports ⇒ validated. Product default is 2.
EBGM is the Empirical Bayes Geometric Mean of the reporting ratio under a two-component Gamma-Poisson (DuMouchel MGPS) posterior; EB05 is its conservative 5th-percentile lower bound — the score Canary triages on because it self-corrects for the small counts that inflate raw PRR/ROR.
All pairs · ranked by EB05
| Drug → Event | a | PRR | EB05 | Disposition |
|---|---|---|---|---|
| SSRI-Z → Serotonin syndrome | 121 | 18.15 | 10.99 | Validated signal |
| Statin-Y → Rhabdomyolysis | 138 | 14.87 | 9.48 | Validated signal |
| Biologic-V → Injection-site reaction | 105 | 11.59 | 8.39 | Validated signal |
| Anticoagulant-X → GI haemorrhage | 288 | 6.95 | 5.42 | Validated signal |
| NSAID-W → Acute kidney injury | 191 | 5.00 | 3.97 | Validated signal |
| NSAID-W → GI haemorrhage | 163 | 3.41 | 2.79 | Validated signal |
| SSRI-Z → Nausea | 229 | 1.42 | 1.24 | Watchlist |
| SSRI-Z → Headache | 182 | 1.31 | 1.13 | Watchlist |
| NSAID-W → Nausea | 238 | 1.21 | 1.07 | Watchlist |
| Statin-Y → Acute kidney injury | 49 | 1.32 | 0.97 | Dismissed |
| Anticoagulant-X → Acute kidney injury | 48 | 1.21 | 0.89 | Dismissed |
| Statin-Y → Serotonin syndrome | 12 | 1.21 | 0.62 | Dismissed |
Every statistic is computed in your browser from the synthetic 2×2 tables — no backend. Notice a high raw count is not enough: a common event like a background headache can post a big a yet stay dismissed once EB05 shrinks it against how often it is reported anyway. That shrinkage is what separates a real signal from reporting volume.
Why this is more than a toy
These are the FDA/EMA/WHO-UMC disproportionality formulas — Evans (2001) PRR, van Puijenbroek (2002) ROR, and DuMouchel's (1999) Multi-item Gamma-Poisson Shrinker — ported faithfully from CuRE's signal-detection methodology, including the product's default MGPS prior and the EB05 ≥ 2 triage rule. The key move a real PV engine makes, and this demo shows, is shrinkage: a common event with a big raw count stays dismissed once EB05 corrects for how often it is reported anyway. In the product, Canary runs this over an OMOP-native report store and routes validated signals into case management.
See CuRE Canary in action
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