Reference
AI-Native CRO Platform Architecture — L0 to L5 layered stack
An “OS of agents” sitting over commodity GxP systems of record. The proprietary moat is at L1–L4 (data spine, orchestration, agents, accountability). Every regulated action passes through a 21 CFR Part 11 e-signature gate. Click any layer in the diagram to jump to its detail card below.
L0
Vendor Connectors
Read/write adapters to commodity GxP systems of record — eTMF, EDC, CTMS, safety, IRB, eISF.
L0
Vendor Connectors
Read/write adapters to commodity GxP systems of record — eTMF, EDC, CTMS, safety, IRB, eISF.
L0 is the boring-but-critical glue. Every external system talks through a typed adapter under services/integrations/<system>/ so that the rest of the platform sees a stable shape regardless of vendor churn. Adapters are stateless and idempotent.
Technologies
No public console routes — this layer is server-side only.
L1
Data Spine
Provenance, audit trail, staging tables, vector index, model registry — the canonical record of every action.
L1
Data Spine
Provenance, audit trail, staging tables, vector index, model registry — the canonical record of every action.
L1 is the immutable substrate. Every regulated write carries created_by, created_at, and provenance_id. Agents write to staging only — promotion to live requires a Part 11 signature row. ALCOA+ is enforced at the schema layer.
Technologies
Related routes
L2
Orchestration Kernel
Policy governor, autonomy classes, scheduling, event bus — decides what agents are allowed to do and when.
L2
Orchestration Kernel
Policy governor, autonomy classes, scheduling, event bus — decides what agents are allowed to do and when.
L2 brokers every agent action against autonomy class and policy. A4 is prohibited; default is A2 with a human gate. Scheduling is handled by Vercel Cron + Supabase pg_cron (Inngest deferred per ADR 0006).
Technologies
L3
Agents
The 30+ specialized agents — protocol intake, essential documents, audit trail, knowledge RAG, evaluation.
L3
Agents
The 30+ specialized agents — protocol intake, essential documents, audit trail, knowledge RAG, evaluation.
L3 is where the proprietary value lives. Each agent has a pinned model id in the registry, ≥10 promptfoo goldens, and a credibility dossier under docs/regulatory/. Authoring agents must ground every claim through the citations lib.
Technologies
Related routes
L4
Accountability
E-signature gate, model registry version control, validation evidence — the regulatory wall.
L4
Accountability
E-signature gate, model registry version control, validation evidence — the regulatory wall.
L4 is the line a regulator audits. Re-auth + intent + immutable signature row is required for every staging→live promotion. Any prompt change bumps a registry row; CI blocks merges without one.
Technologies
Related routes
L5
Consoles
The Next.js apps humans actually touch — operations, sponsor portal, inspection view, this very diagram.
L5
Consoles
The Next.js apps humans actually touch — operations, sponsor portal, inspection view, this very diagram.
L5 is the human surface. The operations console shows staging review queues; the sponsor portal accepts requests through the same A2 gate; the inspection view assembles a Part 11 evidence binder on demand.
Technologies
Related routes