Phase 1 → Phase 4 build plan

Data spine (Supabase + Drizzle + RLS)

cro.* schema in Supabase with RLS deny-by-default, pgvector enabled, append-only provenance_event, staging_record, and signature tables. Drizzle migrations applied to project clkifpedvomnpgajdsid.

2026-02-12

Orchestrator kernel

services/orchestrator with the governor policy enforcement, staging-write contract, and provenance emitter. Every regulated action flows through governor.ts.

2026-02-20

E-signature service (21 CFR Part 11)

services/esign with re-authentication, stated intent, immutable signature row, and the staging→live promotion gate.

2026-03-04

Audit-trail agent (27)

agents/27-audit-trail surfaces ALCOA+ gaps from the provenance log and proposes remediations into staging.

Agents: 27-audit-trail

2026-03-18

Knowledge / RAG agent (30)

agents/30-knowledge-rag with pgvector-backed citation-grounded retrieval. Rejects any non-cited claim via packages/citations.

Agents: 30-knowledge-rag

2026-03-26

Evaluation agent (31)

agents/31-evaluation runs the promptfoo golden suite, gates prompt changes on model-registry version bumps, and ships eval dashboards.

Agents: 31-evaluation

2026-04-02

Essential Documents agent (04)

agents/04-essential-documents authors and tracks ICF, protocol, IB, and other TMF essentials. A2 supervised — drafts to staging, human signs.

Agents: 04-essential-documents

2026-04-15

Web inspection view

apps/web /inspection page surfaces the full evidence binder — signed records, provenance events, agent decisions, linked SOPs — in a single navigable view.

2026-04-22

L5 web consoles (recent features)

The web app at apps/web has shipped a full suite of consoles: staging, studies, agents, costs, risks, timeline, compliance, sitemap, digest, glossary, models, tour, /me, search, and validation registry.

2026-06-04

Data Management cluster

agents/05-edc-design, agents/06-data-cleaning, agents/07-database-lock — supervised authoring of CRFs, edit checks, and the lock package.

Agents: 05-edc-design, 06-data-cleaning, 07-database-lock

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Feasibility cluster

agents/01-site-feasibility, agents/02-country-strategy, agents/03-enrollment-forecast — proposed site lists, country mixes, and enrollment curves with cited evidence.

Agents: 01-site-feasibility, 02-country-strategy, 03-enrollment-forecast

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MedDRA / WHODrug controlled-terminology service

services/integrations/meddra and services/integrations/whodrug — looked up by safety, EDC, and medical-writing agents. Blocked on commercial license procurement.

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Safety / Pharmacovigilance cluster

agents/15-safety-intake, agents/16-narrative-drafting, agents/17-signal-detection. Causality assessment remains a human-only act — enforced architecturally in packages/policy.

Agents: 15-safety-intake, 16-narrative-drafting, 17-signal-detection

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Protocol intake agent

agents/00-protocol-intake — parses sponsor-supplied protocols, extracts structured study parameters, and seeds the rest of the agent cluster.

Agents: 00-protocol-intake

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RBQM wave

agents/12-risk-assessment, agents/13-quality-tolerance-limits, agents/14-central-monitoring — risk register, QTL drift detection, central-monitoring triage.

Agents: 12-risk-assessment, 13-quality-tolerance-limits, 14-central-monitoring

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Medical writing cluster

agents/20-csr-drafting, agents/21-publication-support — citation-grounded section drafting for CSRs and manuscripts. A2 supervised across the board.

Agents: 20-csr-drafting, 21-publication-support

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Biostats SAP authoring

agents/22-sap-drafting drafts the Statistical Analysis Plan with cited references back to the protocol, ICH E9, and CDISC standards.

Agents: 22-sap-drafting

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TLF generation with double-programming gate

agents/23-tlf-primary and agents/24-tlf-validator produce two independently programmed copies. Promotion to live requires a numeric-equality gate plus a human signature — the double-programming gate.

Agents: 23-tlf-primary, 24-tlf-validator

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