Roadmap

Phase 1 → Phase 4 build plan

Every workstream that has shipped, is in flight, is planned, or is blocked. One source of truth for "what are we actually building?" — sourced from apps/web/src/data/roadmap.ts.

Phases

Done

In progress

Planned

Blocked

Phase

All phases Phase 1 Phase 2 Phase 3 Phase 4

Status

All statuses Done In progress Planned Blocked

Phase 2 — Operations cluster

Light up the agents that touch day-to-day trial operations: data management, feasibility, and the regulated dictionaries that everything downstream depends on.

ETA 2026-Q3planned

Workstream	Status	Shipped
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	planned	—
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	planned	—

Workstream

Status

Shipped

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

planned

—

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

planned

—

Phase 3 — Safety, protocol, RBQM, medical writing

Add the agents that drive medical and safety decisions, plus the protocol intake and the risk-based quality management wave. AI never makes the causality call.

ETA 2026-Q4planned

Workstream	Status	Shipped
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	planned	—
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	planned	—
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	planned	—
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	planned	—

Phase 4 — Biostats and TLF

Close the loop with statistical analysis planning and table/listing/figure generation. Highest-stakes work — gated on a double-programming sign-off.

ETA 2027-Q1planned

Workstream	Status	Shipped
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	planned	—
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	planned	—

Workstream

Status

Shipped

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

planned

—

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

planned

—

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