Agentic AI for Clinical Data

End-to-End Clinical Data
Automation, Reimagined.

From protocol authoring to regulatory submission — ClinMaker orchestrates the entire clinical data lifecycle with autonomous AI agents, so your team can focus on science.

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Dashboard
Studies
Ingestion
Validation
SDTM
Analytics
Active Studies
12
Open Queries
247
Coding Complete
94.2%
AI Actions Today
1,847
Recent Study Activity
ONCO-2024-0145Live98.4% clean
CARDIO-2025-0032UAT87.1% clean
NEURO-2024-0089Live96.7% clean
DERM-2025-0011Build--
Query Trend (30d)
21 CFR Part 11 • Annex 11 • ICH E6(R3) GCP • CDISC CDASH / SDTM / ADaM • Built for GxP-regulated environments
9
Autonomous Agents
142
Data Model Tables
400+
API Endpoints
100%
Audit Trail Coverage
The Platform

One pipeline. Protocol to submission.

Click any stage to explore how ClinMaker automates each step of the clinical data lifecycle.

📄
Protocol
Authoring
🛠
Study
Build
📥
Data
Ingestion
✅
Data
Management
🚀
SDTM /
ADaM
📈
Analytics &
Profiles
📚
CDISC
Standards
⚡
AI
Insights
Protocol Digital Authoring

Author protocols with intelligence, not just text

ClinMaker's protocol authoring module lets you build study protocols in a structured, version-controlled environment with AI assistance at every step.

  • Rich-text editor with ICH M11 section structure
  • AI-powered section generation from study metadata
  • Version control with side-by-side diff comparison
  • One-click DOCX protocol draft export
  • Schedule of Activities matrix editor
  • Country-specific regulatory addendum support
Protocol Sections
Editor
Versions
Export
B
I
H1
H2
T
📎
6.1 Study Design
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of Compound XYZ-401 in participants with moderate-to-severe...
6.2 Endpoints
Primary: Change from baseline in HbA1c at Week 24.
Secondary: Proportion of participants achieving HbA1c <7.0%...
Study Build

From protocol to EDC in hours, not weeks

Translate protocol requirements into a CDASH-aligned EDC design with forms, fields, edit checks, and codelists — ready for Rave or Veeva.

  • AI-assisted form and field generation from protocol
  • CDASH-aligned CRF library with reusable templates
  • Edit check builder with rule engine
  • Codelist management with CDISC controlled terminology
  • Rave Architect / Veeva Vault EDC artifact export
  • ePRO/eCOA multilingual localization support
Study Build — Forms
Forms
Edit Checks
Codelists
Demographics
12 fields · Complete
Vital Signs
8 fields · Complete
Adverse Events
15 fields · Complete
Con Medications
11 fields · Review
Lab Results
14 fields · Complete
Eligibility
9 fields · Complete
EDIT CHECKS: 47 active rules
92% validation coverage across all forms
Data Ingestion

Connect any source. Normalize everything.

ClinMaker's intelligent ingestion pipeline connects to EDCs, safety databases, labs, imaging, ePRO, RTSM, and devices — recognizing schemas and mapping to a canonical data model automatically.

  • 280+ column alias dictionary with AI inference
  • Four-step pipeline: Connect, Validate, Normalize, Publish
  • Quarantine workflow for malformed data
  • Dry-run test loads before going live
  • Incremental loads with change detection
  • Source-specific health dashboards
Ingestion Sources
Sources
Staging
Upload
SourceTypeStatusLast Sync
Rave EDCAPILive2 min ago
Argus SafetySFTPLive15 min ago
Central LabFileLive1 hr ago
ePRO VendorAPIStaging--
ECG DeviceFileConfig--
Data Management

Validate, code, reconcile, and query — all in one place

ClinMaker combines validation, medical coding, reconciliation, and query management into a unified data management workflow powered by AI agents.

  • 3-level validation: syntactic, logical, cross-source
  • AI-assisted MedDRA and WHO Drug coding
  • SAE and external vendor reconciliation
  • Unified query lifecycle with AI-generated text
  • Clean patient tracker with real-time metrics
  • Database lock workflow with readiness checks
Data Management
Queries
Coding
Recon
QuerySubjectTypeStatus
Missing AE end date101-0034LogicIssued
Dose > protocol max103-0112RangeOpen
Lab unit mismatch102-0078ReconResolved
Visit date vs window101-0045LogicIssued
847
Resolved
247
Open
94.2%
Coded
SDTM / ADaM Transformation

Canonical data to submission-ready datasets

AI-bootstrapped mapping specifications transform your operational data into SDTM and ADaM domains with full traceability, conformance validation, and Define.xml generation.

  • AI-suggested variable mappings with human review
  • SDTM domain generation (DM, AE, LB, VS, CM, EX...)
  • ADaM dataset generation (ADSL, ADAE, ADLB...)
  • Define.xml and annotated CRF output
  • Conformance validation with issue tracking
  • Complete source-to-SDTM traceability
SDTM Mappings — DM Domain
Mappings
Validate
Package
subject.dob
→
DM.BRTHDTC
subject.sex
→
DM.SEX
subject.race
→
DM.RACE
site.country
→
DM.COUNTRY
intervention.start
→
DM.RFSTDTC
CONFORMANCE
96% conformant · 3 warnings · 0 errors
Analytics, Patient Profiles & Trackers

See everything. Track every patient.

Role-aware dashboards, rich longitudinal patient profiles, and clean patient trackers give your team complete visibility into study progress and data quality.

  • Role-aware KPIs for DM, Safety, CRA, Biostat, QA
  • Rich patient profiles with full longitudinal timeline
  • Clean patient tracker with real-time completeness
  • Site performance and data quality trends
  • Enrollment and event forecasting
  • Cross-study intelligence and benchmarks
Patient Profile — 101-0034
Timeline
Labs
AEs
Subject
101-0034
Status
Active
Site
Memorial Hospital
Enrolled
2025-09-14
Visit Timeline
✓
Screen
✓
Wk 4
✓
Wk 12
•
Wk 24
•
EOS
CDISC Standards Library

Complete standards, built in

ClinMaker ships with a comprehensive CDISC standards library and supports sponsor-specific data standards, so your team always works with the right terminology and metadata.

  • CDASH, SDTM, ADaM implementation guides
  • CDISC Controlled Terminology (all versions)
  • MedDRA and WHO Drug dictionary integration
  • Sponsor-specific standard extensions
  • Master Data Repository with version control
  • Cross-study standard reuse and governance
Standards Library
CDISC
Sponsor
MedDRA
StandardVersionStatus
SDTM IG3.4Active
ADaM IG1.3Active
CDASH IG2.2Active
CT Package2025-12Active
MedDRA27.1Active
WHO DrugMar 2026Active
AI Insights

Intelligence that surfaces what matters

ClinMaker's AI layer doesn't just automate tasks — it learns patterns, detects anomalies, predicts risks, and surfaces insights that help you make better decisions faster.

  • Anomaly detection across all data domains
  • Predictive analytics for enrollment and events
  • Risk-based monitoring recommendations
  • Cross-study intelligence and benchmarking
  • AI-assisted query text generation
  • Natural language chat assistant for data questions
AI Insights
Alerts
Predict
Chat
Anomaly Detected
Site 103 shows 3x higher AE reporting rate vs study average. Recommend targeted review.
Prediction
Based on current query resolution rate, DB lock target of Dec 15 is achievable with 87% confidence.
Coding Suggestion
14 verbatims match existing auto-code patterns with >95% confidence. Recommend batch approval.
Standards

CDISC-native. Sponsor-extensible.

ClinMaker is built on CDISC standards from the ground up, with full support for sponsor-specific extensions and custom data standards.

📋

CDASH

Collection standard for CRF design

📈

SDTM

Tabulation standard for submissions

📊

ADaM

Analysis standard for statistical tables

📚

Controlled Terminology

Versioned CDISC CT packages

🏥

MedDRA

Medical coding dictionary

💊

WHO Drug

Drug coding dictionary

🛠

Define.xml

Dataset metadata for submissions

🏠

Sponsor Standards

Your custom extensions and libraries

Ready to automate your clinical data lifecycle?

See how ClinMaker can accelerate your trials from protocol to submission while maintaining full GxP compliance.

Request a Demo →