Pharmacovigilance & Drug Safety

AI that an FDA BIMO inspector can replay signal by signal.

ICH E2B(R3) + EU GVP demand that every PV decision be traceable to source. CrewAI and Relevance can do triage; they can’t produce the audit trail. Sovereign Matrix is the only AI agent stack that ships ALCOA+ records and cryptographic chain-of-custody for every safety signal.

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Primitives shipped for pharmacovigilance

ICSR triage with full citation chain

Agents ingest case intakes from MedDRA-coded sources (call center, literature, social listening, partner-CRO feeds). Severity, expectedness, and listedness classifications cite the exact source row. Hallucination guard (verifier layer 6) rejects any unsupported claim before it reaches the medical reviewer.

Signal detection with replay-bundle export

Agents run disproportionality analyses (PRR, ROR, IC) over your aggregated PV dataset. Every signal emits a signed receipt with the underlying case ids; medical-safety officers replay the analysis on demand. Cook 56 audit-bundle subscription delivers the monthly signal review to Drug Safety leadership.

Aggregate report drafting (PBRER / PADER / DSUR)

Agents draft PBRER (EU), PADER (US legacy), and DSUR (clinical) sections against the latest cumulative case dataset. Citation guard verifies every cumulative incidence figure, every signal status, every benefit-risk paragraph ties to source data. Multi-party attestation: PV scientist + medical reviewer + safety officer co-sign.

ICH E2B(R3) XML compatibility

Receipts include the canonical E2B(R3) message identifier so reports route directly into your safety database (Argus / ArisGlobal / Veeva Vault Safety) without remapping. Inspector pulls the bundle; system imports it natively.

21 CFR Part 11 + EU GVP audit posture

ALCOA+ records on every action (Cook 94 receipt-chain ratchet makes the trail tamper-evident). EU GVP Module VI 'minimum criteria for a valid ICSR' enforced at agent intake. FDA BIMO inspector receives a replay-ready bundle with cryptographic chain-of-custody.

Three workflows landing on day one

"Triage today's case intake — flag any expedited reports for medical review."

Agent ingests the day's intake from call center logs + medical literature + partner-CRO feeds.
Classifies seriousness (death / life-threat / hospitalization / disability / congenital / other medically-important).
Determines expectedness against the latest CCDS for each implicated drug.
Flags expedited reports for 15-day reporting; routes to medical reviewer with citation map.

Triaged case load + signed receipts + expedited-flag list. PV ops time -65% on routine triage, zero missed-expedited cases in QA review.

"Run this quarter's PRR analysis for drug X across the cumulative dataset."

Agent assembles cumulative ICSRs for drug X + cumulative ICSRs across the reference population.
Computes PRR + ROR + IC for every MedDRA PT pair exceeding the disproportionality threshold.
Outputs signal list with case-level drill-down; receipt commits the dataset hash so the analysis is replayable.
Bias auditor flags any signal whose case mix is demographically skewed for human review.

Quarterly disproportionality report + replay bundle. Medical reviewer triages signals; FDA / EMA inspector replays any analysis on demand.

"Draft the PBRER section 16 benefit-risk evaluation for the upcoming PSUR filing."

Agent assembles the cumulative + interval safety data, the efficacy update, and the regulator's prior-cycle assessment.
Drafts section 16 with explicit citations to every claim.
Hallucination detector rejects any phrasing that overstates the benefit or minimizes a known signal.
PV scientist + medical reviewer + safety officer co-sign via multi-party attestation (Cook 39).

PBRER section 16 + signed handover to regulatory affairs. -70% on first-draft authoring time, zero unsupported claims in QA review.

Pre-mapped to PV regulatory controls

ICH E2B(R3) — Individual Case Safety Reports

ICH E2D — Post-Approval Safety Data Management

ICH E2E — Pharmacovigilance Planning

ICH E2F — Development Safety Update Reports (DSUR)

EU GVP Modules I-XVI

FDA 21 CFR 314.80 — Postmarketing reporting of ADR

21 CFR Part 11 — Electronic Records / Signatures

FDA BIMO inspection-readiness for PV operations

From case intake to PSUR — every safety decision cryptographically signed.

Sovereign’s signed-receipt fabric is the safety net your PV organization wants when the FDA arrives. Continuous ALCOA+ evidence. Replayable signal analyses. Zero deficiency findings on §314.80.

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