Clinical Trials & Pharmacovigilance

AI you can put in front of an FDA BIMO inspector.

ICH GCP E6(R3) + 21 CFR Part 11 demand attributable, contemporaneous, tamper-evident records with cryptographic signatures. Sovereign Matrix is the only AI agent stack that ships an inspection-ready TMF posture board out of the box.

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Primitives shipped for clinical trials

21 CFR Part 11 electronic signatures

Multi-party attestation (Cook 39) gives PI + sponsor + CRA cryptographically-distinct signatures on every monitoring report. Each signature carries name, timestamp, and meaning-of-signature — exactly what 21 CFR Part 11 §11.50 demands.

ICH GCP E6(R3) ALCOA+ audit trails

Every agent action emits an attributable, contemporaneous, original, accurate record. Receipt-chain ratchet (Cook 94) makes the trail tamper-evident — inspectors verify in-place without trusting the sponsor's database.

Protocol-deviation logging + impact analysis

Site staff describe the deviation in natural language; the agent classifies severity, maps it to the protocol section, drafts the CAPA, and queues it for sponsor review. Hallucination guard ties every claim to the source document.

Trial Master File (TMF) automation

Receipt timeline (Cook 55) reconstructs the full TMF chronology from signed source records. Inspection-ready bundles auto-generate for the EMA / FDA inspector with a single CTA.

Site-monitoring visit narratives

CRA dictates findings; agent composes the monitoring report against the latest protocol amendment. Citation guard verifies every dose, every endpoint, every adverse event ties back to source data.

Three workflows landing on day one

"Draft the SDV monitoring report for yesterday's Site 042 visit."

Agent pulls the visit log, the source-data verification entries, and the latest protocol amendment.
Composes the GCP-format monitoring report with every finding tied to source.
PI signs electronically (21 CFR Part 11 §11.50); CRA co-signs; sponsor receives via attested bundle.
Audit-bundle subscription delivers to the TMF on a fixed schedule.

Monitoring report + receipts + ALCOA+ trail. -75% on CRA documentation time, zero §11.50 deficiencies in the inspection log.

"Log a major protocol deviation: subject 048 missed Week 4 visit window."

Site staff describes the deviation in plain language.
Agent classifies as major per the deviation matrix, drafts the impact assessment.
Sponsor medical monitor co-signs; CAPA draft auto-attaches.
Bias auditor flags any language that might minimize the deviation.

Documented deviation + CAPA + signed attestations. Inspector replays the trail in minutes.

"Prepare the inspection-readiness package for FDA BIMO visit."

Agent assembles the trial-master-file from signed source records.
Receipt timeline shows every protocol amendment, deviation, AE narrative, and monitoring visit.
Cross-tenant ZK proof (Cook 106) shares aggregate metrics with sponsor without exposing patient PHI.
Inspector receives a replay-ready bundle pre-loaded into their workpaper system.

BIMO inspection prep package in days, not months. Cryptographic chain-of-custody, zero gap.

Pre-mapped to clinical-research controls

ICH GCP E6(R3) — Good Clinical Practice

21 CFR Part 11 — Electronic Records / Signatures

21 CFR Part 50 — Informed Consent

21 CFR Part 56 — IRB / IEC oversight

EU CTR 536/2014 — Clinical Trials Regulation

ALCOA+ — Data-integrity principles

EMA / FDA BIMO inspection-readiness

HIPAA + GDPR — PHI / patient-data sovereignty

From source data to inspection bundle — every step signed.

Sovereign’s signed-receipt fabric replaces the screenshot-and- paste TMF prep your clinical-ops team does today. Continuous ALCOA+ evidence. Replayable for the inspector. Zero deficiency findings on §11.50.

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