cm.platform · early access · v0.5.43

End-to-end clinical data
workflow automation.
AI-assisted. Human-in-the-loop.

ClinMaker is the GxP-grade platform for the full clinical data lifecycle. Live today: USDM-native protocol authoring and protocol-to-EDC study build, anchored in DDF, USDM 4.0, and ICH M11. Other workflow modules are in active development.

Talk to us → See the platform → 2 modules live · early access · 21 CFR Part 11 · CDISC-native
00,00 cm.dash/live v0.5.43 2026-05-19 14:08:22 UTC
cm-dash // overview scope: protocols + builds env: prod live
Protocols in flight+3 wk
12
Sections drafted+87 d
487
USDM 4.0 score↗
~100/100
Study builds+1 wk
4
Protocols / authoring●
ACQ-2026-001
92% approved
ONCO-2026-014
71% review
CARDIO-2026-007
38% drafting
RESP-2026-022
96% approved
DERM-2026-005
14% drafting
Standards / pinned·
USDM 4.0
ICH M11 Step 4
DDF aligned
CDASH 2.2
NCI CT 2024-09-27
+ 2 Modules live
↗ ~100/100 USDM 4.0 round-trip
· 84 ICH M11 sections
· DDF CDISC-aligned
· 21CFR Part 11 posture
§A · live currently shipped 2 modules GxP-graded · audited

Available now.
Two modules live.

Both are standards-anchored, audit-aware, and ready for early-access pilots. AI assists where structured drafting is high-leverage; humans approve every change.

deeper tour →
§01 live protocol_authoring
Protocol authoring.
USDM-native.

Author M11-aligned protocols section by section with a Claude-powered co-pilot. Every Code field binds to CDISC CT. CORE rules engine runs as the pre-export compliance gate.

DDF USDM 4.0 ICH M11 NCI CT
  • 84-section M11 generator, every section AI-drafted, human-approved
  • USDM 4.0 export + import; round-trip score ~100/100 on CORE rules
  • Bidirectional consistency — amendments auto-flag stale sections
  • Every AI decision audited with model version + actor type
read §01 in depth →
§02 live study_build
Study build.
Protocol to EDC.

Read a USDM-based study definition (or a protocol PDF, or a USDM-JSON export) and generate a CDASH-aligned casebook. Forms, fields, codelists, edit checks. Deploy to Medidata Rave or Veeva Vault.

USDM PDF USDM JSON CDASH 2.2
  • Three intake formats: USDM study definition, protocol PDF, USDM JSON
  • CDASH casebook output ready for Rave Architect or Veeva Casebook Objects
  • Visit schedule + form set derived from the protocol's SoA
  • Auto-generated SDS, eCRF spec, UAT scenarios
read §02 in depth →
§B · roadmap under development 10 modules target: end-to-end

On the roadmap.
Under development.

The vision is end-to-end automation, module by module, with human review gates at every AI assist. Here's what's next on the build path. Pilots may include scoped previews.

vision → end-to-end
§03
Data ingestion
Unified vendor pipeline for EDC, central labs, imaging, ePRO, RTSM, devices.
under dev
§04
Validation
Three-level rule engine (syntactic, logical, cross-source) with severity routing.
under dev
§05
Query management
One lifecycle across validation findings, reconciliation, coding ambiguities.
under dev
§06
Medical coding
MedDRA + WHO Drug with AI-assist proposals and human review gate.
under dev
§07
Reconciliation
SAE + external sub-agents for safety-DB and vendor cross-source consistency.
under dev
§08
SDTM / ADaM
Mapping spec, conformance, Define.xml, ADaM scaffolds for submission.
under dev
§09
Analytics
Role-aware KPIs, risk flags, lock-readiness gauges, study insights.
under dev
§10
Patient profile
Longitudinal subject view (visits, AEs, labs, vitals, exposure, ePRO).
under dev
§11
Audit trail
Append-only, ALCOA+, 7-year retention. Infrastructure exists; workflow integration in progress.
under dev
§12
User admin & help center
RBAC, MFA, separation of duties, in-app guidance with citation-verified AI Guide.
under dev
cm.demo

Bring us a protocol.
We'll show you the live modules.

Thirty-minute working session — not a deck. Live USDM authoring, a mid-study amendment flow, and a CDASH study build. Early-access pilots welcome.

Talk to us → or hello@clinmaker.com