Every interaction with a healthcare provider is regulated. Orange Vault scans every DCR for off-label promotion, missing fair-balance, and gift-value violations — extracts adverse events from free-text — and gives you an immutable audit trail across 18 regulated tables.
Six modules built for the regulated reality: scanning, extracting, gating, versioning, logging, reviewing.
Every DCR scanned for off-label, fair-balance, gift-value, unsubstantiated claims.
Free-text scanned for ADRs. Drug, symptoms, severity, timeline auto-extracted.
Append-only consent records per doctor, per channel. Outreach gated across the suite.
Drug labels, clinical trials, safety updates, approval letters — versioned with workflow.
Every regulated mutation across 18 tables in an immutable log. Per-row history view.
Acknowledge, dismiss, escalate, resolve. Every decision audited.
Compliance officers operate primarily in Vault, but its sensors live across CRM, PromoMats, and Medical.
The compliance home — findings queue, AE detection, consent, audit, document register.
Source of every DCR scanned by the watchdog. Inline guidance to reps before submission.
MLR workflow with versioned approvals. Every promotional asset tied to an audit log entry.
Two AI capabilities, both running over the same hybrid retrieval engine. Strict human confirmation on AE.
Promotional compliance scanner with optional drug-label context per region.
PV auto-extraction from unstructured text — drug, symptoms, severity, timeline. Human confirms.
Auto-route incoming regulatory mail to the right product, region, and reviewer.
Spot DCR patterns that look like data fabrication or off-label clustering.
"In the last audit they asked for the row history of one specific DCR from 11 months ago. We had it on screen in 30 seconds."Head of Compliance · mid-cap pharma · 14 months on Orange
Orange speaks the language of each role — without forcing one team to adopt another's tools.
30-minute demo. We'll mock your real workflow live.
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