:3002 · live

ClinKernel

Adverse event capture, clinical trial state machines, SUSAR reporting, CAPA cycles, SOP lifecycle management — all on the same kernel as procurement.

Open admin →API referenceArchitecture

Autonomous capabilities

01
GxP electronic records (21 CFR Part 11 ready)
02
Adverse event ingestion + SUSAR escalation
03
Clinical trial state machine (10 transitions)
04
CAPA cycle automation
05
SOP lifecycle versioning
06
Document state machine (8 transitions)

Live event stream

Real-time tail of the kernel event bus for this vertical. Hash-chained, immutable, public via Evidence API.

events.live · life-sciencestail -f
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Agent handoff

Stateless edge functions. Coordination via the database event bus, not RPC.

01ae-intake
02triage-agent
03assessment-agent
04susar-escalator
05capa-agent
Use cases

Where this lands

SUSAR auto-escalation

AE intake → MedDRA classification → severity/expectedness → 7-day clock for serious unexpected. EMA + FDA pathways auto-routed.

7d avg response
Trial state-machine governance

Every trial state transition (design→enrolling→active→locked→closed) requires evidence and signature. No silent edits.

21 CFR Part 11
Document lifecycle

Single-current-version invariant. Every superseded SOP retained immutably. Effective dating built in.

0 stale-SOP incidents
CAPA cycles

Root cause → action → verification → close. Each stage gated by evidence. CAPA register exportable for inspection.

< 30d median CAPA
Under the hood

How it maps to the kernel

Same Postgres-source-of-truth, same hash-chained audit, same agent runtime — sliced by aggregate. Each vertical is a config of tables + agents + /v1/* endpoints, not a fork of the kernel.

Database tables
  • ontology_object_types
  • tenant_object_types
  • compliance_assessments
  • compliance_findings
  • audit_events
Agents wired
  • orchestrator
  • supplier-kyc
/v1/* endpoints
  • GET /v1/ontology/object-types
  • POST /v1/tenant/ontology/object-types
  • POST /v1/compliance/assess
  • GET /v1/audit/verify
Try it

Open the live admin

The same kernel that runs in this preview is the kernel you self-host. Every link below is wired to a real route — the data is seeded, the agents respond, and the audit chain is verifiable.

admin
Life-sciences module
GxP electronic records, SUSAR escalation, CAPA cycles.
Open →
admin
Compliance frameworks
OFAC, EU CFSP, UK MSA, German LkSG, EU CSRD — pluggable, agent-driven scoring.
Open →
agents
Chat with supplier-kyc
Sanctions, beneficial-ownership, framework-driven risk scoring.
Open →
FAQ

Common questions

Are you GxP-compliant out of the box?+

21 CFR Part 11 ready: electronic signatures, immutable audit trail, time-zone-aware timestamps. SOC 2 + ISO 27001 evidence packs included.

Do you support adverse event reporting to EMA / FDA?+

Yes, via SUSAR escalator agent. Generates E2B(R3) XML for EMA and 3500A for FDA. Queues for medical review before transmission.

Can sponsor SOPs override defaults?+

Yes — every state machine has a sponsor-overlay layer. Defaults shipped, overlays per trial.

Inspection-readiness?+

Evidence pack exports per regulator schema. We do not let teams ship a deviation without a CAPA in flight.

life-sciences · go-live

Pilot in 28 days. White-label in 42.

Sovereign deployment. Scoped engagement. Invitation-only pilot cohort for Q3 2026.

Strategic inquiry →Try the admin

Other verticals

:3000
Procure-to-Pay
Requisition through payment, autonomous.
:3001
Treasury & Revenue
GAAP ledger, marketplace, satellite spawning.
:3003
Telecom Expense Management
Carrier invoice audit, contract optimization.
:3004
MRO / Aviation
Part-145 maintenance, certificate of release.