Safety & Quality bundle · for VP Quality
Catch risk, report safety, and close the loop on one record
Caliber, Canary, and Credo give the quality office one substrate for risk monitoring, pharmacovigilance, and the QMS — every signal, case, and CAPA tied to the same governed OMOP record an inspector can trace.
The problem today
Quality leaders run RBQM dashboards, a safety database, and a QMS that don't talk to each other, so a KRI breach becomes an email, a deviation is free-text re-keyed from the EDC, and inspection evidence gets assembled by hand across systems.
Faster
Signal to action without re-keying
A Caliber KRI breach or Canary case can surface in Credo as a candidate deviation or CAPA instead of an email, so the signal-to-CAPA loop ICH E6(R3) expects runs as a workflow rather than manual hand-offs.
Better
Risk detected before the CRF shows it
Because risk and safety signals compute off the same governed OMOP record, Caliber can flag EHR-observed events a site has not yet reported and Canary can evaluate them against real-world history — context CRF-bound tools structurally cannot see.
Cheaper
One validation story, not three
Risk, safety, and quality records share the platform's hash-chained Part 11 audit envelope, e-signature, and OMOP substrate, replacing three separately-validated point tools with one inspection-readiness story.
How this bundle composes
Capture issues, monitor risk, report safety, and preserve the validation evidence an inspector will ask for.
Caliber turns risk-based quality management into an always-on early-warning system, detecting risk where it appears first — including EHR-observed events a site has not yet reported — and routing it to the person who can act.
Canary is the safety system of record for CuRE-platform studies and registries — running the regulatory case lifecycle from intake through E2B(R3) submission and running signal detection on the same OMOP store the rest of the suite reads.
Credo is the clinical-GCP quality management system — the canonical home for deviations, CAPA, and GCP/protocol training, with every quality event tied to the study-conduct data it concerns rather than parked in a separate quality silo.
Curtain gives privacy and data-governance leads a human-in-the-loop review over de-identification and re-identification risk, so data releases are gated on inspectable evidence computed against the same governed OMOP record the rest of CuRE analyzes — not a separate privacy tool with its own copy of the data.
Safety signal to quality action
Follow one safety concern from a pharmacovigilance signal into a tracked quality action — Canary's real MGPS methodology validates a drug–event disproportionality signal (EB05 ≥ 2), Caliber's centralized statistical monitoring turns it into an AE-under-reporting KRI that flags the outlier site, and Credo grades the deviation, routes it to a CAPA, and binds the CAPA's effectiveness close back to the same KRI so fresh data — not a human assertion — decides the fix worked.
Surface the validated disproportionality signal
Over the whole synthetic spontaneous-reporting database, Canary's real MGPS methodology quantifies which drug–event pairs report more than expected. The shrinkage-robust EB05 validates the genuine signal and dismisses the merely-frequent.
| Drug | Event | PRR | EB05 | Triage |
|---|---|---|---|---|
| SSRI-Z | Serotonin syndrome | 18.2 | 10.99 | validated |
| Statin-Y | Rhabdomyolysis | 14.9 | 9.48 | validated |
| Biologic-V | Injection-site reaction | 11.6 | 8.39 | validated |
| Anticoagulant-X | GI haemorrhage | 7.0 | 5.42 | validated |
| NSAID-W | Acute kidney injury | 5.0 | 3.97 | validated |
DuMouchel MGPS shrinkage separates the planted adverse reaction from background events that are merely reported often — only the validated pair carries EB05 ≥ 2. That validated pair is the safety signal this journey hands to quality.
A validated safety signal is not the end — it is a quality question: is a site under-handling this reaction? Caliber's centralized statistical monitoring takes it up next.
This is the full cross-app journey — open it alongside every CuRE journey.
Why it holds up
- Caliber, Canary, and Credo read and write to the same governed OMOP record, so a deviation, a safety case, and a CAPA can point at the exact subject, visit, and site row they concern — not a free-text copy.
- Quality events flow across the suite: Caliber RBQM signals and Canary case throughput can arrive in Credo as candidate deviations or CAPAs, and dispositions flow back as context.
- Every risk signal, safety case, and quality-event mutation is sealed in the platform's hash-chained 21 CFR Part 11 / Annex 11 audit trail with e-signature, so the validation evidence an inspector asks for is a by-product, not a project.
- Capability direction: aggregate safety reporting, live-gateway E2B(R3) connectivity, supplier/CRO oversight, and cross-study KRI benchmarking are positioned around the same OMOP evidence base, not delivered as separate integrations.
The apps in this bundle
Caliber turns risk-based quality management into an always-on early-warning system, detecting risk where it appears first — including EHR-observed events a site has not yet reported — and routing it to the person who can act.
- RWD-native RBQM can flag EHR-observed events a site has not reported yet, then draft the investigation narrative and CAPA trail.
- The signal engine drives both execution surfaces CuRE owns — Control monitoring-visit planning and Capture targeted SDV — the closed RBQM loop CluePoints can't own end-to-end.
Canary is the safety system of record for CuRE-platform studies and registries — running the regulatory case lifecycle from intake through E2B(R3) submission and running signal detection on the same OMOP store the rest of the suite reads.
- 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.
Credo is the clinical-GCP quality management system — the canonical home for deviations, CAPA, and GCP/protocol training, with every quality event tied to the study-conduct data it concerns rather than parked in a separate quality silo.
- QMS evidence is linked to the same governed study and operational record as the rest of CuRE, not parked in a separate quality silo.
- Root-cause analysis queries the actual OMOP subject/visit/site data — an RCA no document-only QMS (MasterControl, ETQ) can run.
Curtain gives privacy and data-governance leads a human-in-the-loop review over de-identification and re-identification risk, so data releases are gated on inspectable evidence computed against the same governed OMOP record the rest of CuRE analyzes — not a separate privacy tool with its own copy of the data.
- The de-id review workbench renders prosecutor/journalist/marketer risk and population-uniqueness against a threshold — the numbers a privacy officer signs an Expert Determination on — not just binary k/l/t flags.
- Curtain renders the de-identification and risk work computed by Conduct and Calculate against one governed OMOP record — not a bolt-on privacy tool with its own copy of the data.
See the Safety & Quality bundle in action
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