Medical Data Infrastructure

Auditable Backend for
Adaptive Clinical Trials

Modern trials are moving from centralized hospitals into patients' homes. Unify dynamic patient schemas, wearable time-series metrics, medical imagery, and immutable audit logs in one HIPAA-ready platform.

Clone Clinical Trial Blueprint Read the Docs

The Tension: Protocol Agility vs. Regulatory Rigidity

"Adaptive Trials" change their protocol mid-stream based on early findings, but healthcare software is notoriously hard to modify. You need a database that can evolve its schema in minutes, without ever breaking the strict audit trails demanded by regulators.

✗ Standard healthcare databases require weeks of engineering to add a new biomarker field.
✗ Wearable heart-rate data (metrics) is stored separately from patient demographics (dimensions).
✗ Isolating PII from data scientists usually requires complex data duplication pipelines.
✗ No automatic, tamper-proof logs to track when a doctor alters a dosage.

The Decentralized Trial Blueprint

Omnismith's headless engine supports 9 distinct data types. Build your exact protocol requirements dynamically—from numerical dosages, to blood-test PDFs, to MRI scans, to continuous biometric streams.

✓ Dynamic Templates: Add new biomarkers or lab result fields without database migrations.
✓ Rich Data Types: Natively store medical Images and lab report Files directly on the patient record.
✓ Continuous Metrics: Ingest high-speed biometric data from Apple Watch or Garmin APIs.
✓ Relational Entities: Link specific remote sensors to individual patients.

Template: Trial Participant

Patient Name String (PII)

Contact Phone String (PII)

Current Dosage (mg) Number

Blood Test Results File Upload

Baseline Scan Image Upload

Template: Remote Wearable Device

Device ID String (Unique)

Assigned Patient Reference → Trial Participant

Heart Rate (BPM) Metric (Time-Series)

Blood Glucose Metric (Time-Series)

Malleable Starting Point

Customize with Claude Desktop or Claude Code

What you say next to Claude

Blueprints in Omnismith are malleable starting points rather than rigid templates. Ask Claude to install this blueprint into your Omnismith project, then reshape the resulting schema in plain English:

Prompt for Adaptive Clinical Trials

Install the Clinical Trials blueprint into my Omnismith project, then refine the resulting schema: add an 'Adverse Event Severity' list attribute (Mild, Moderate, Severe) to the Trial Participant template and enforce investigator sign-off in the audit trail.

Runs via Omnismith MCP Server (https://mcp.omnismith.io/mcp) Claude MCP setup guide

Attribute-Level PII Isolation

Keeping data scientists away from Personally Identifiable Information is critical. Omnismith goes beyond module-level permissions by offering Resource-Scoped Permissions at the exact attribute level.

✓ Module Scopes: Allow users to view and edit entities, but disallow module settings.
✓ Template Scopes: Grant access to 'Wearables' but deny access to 'Participants'.
✓ Attribute Deny Lists: Give analysts view-access to a patient's dosage and lab files, but strictly deny access to the 'Name' and 'Phone' attributes.

Analyst Role Configuration

Participant Name

Template: Trial Participant

DENY

Contact Phone

Template: Trial Participant

DENY

Current Dosage (mg)

Template: Trial Participant

VIEW

Immutable Medical Auditing

Omnismith automatically generates a permanent ledger for every single entity change. Prove exactly when a physician authorized a new dosage, or when a lab technician uploaded the latest blood results.

✓ Meets the rigorous audit trail requirements of modern medical software.
✓ Track attribute changes, file uploads, and relationship mapping.
✓ Filter historical changes by physician, date, or specific biomarker.

Patient Audit Ledger

[email protected] 2 hours ago

Changed Current Dosage (mg): 15 → 25

lab-integration-api 1 day ago

Changed Blood Test Results: empty → blood-panel-oct.pdf

[email protected] 2 days ago

Changed Baseline Scan: empty → mri-scan-001.png

Ingest Telemetry Directly from Wearables

Stream high-frequency metric data from smartwatches, continuous glucose monitors, or bespoke remote sensors directly into Omnismith using the optimized metrics endpoint.

# JS: Webhook receiving Apple Watch HealthKit data

async function ingestBiometrics(wearableId, bpm, glucose) {
  const url = `https://api.omnismith.io/v1/entities/${wearableId}`;
  
  await fetch(url, {
    method: 'PATCH',
    headers: {
      'Authorization': 'Bearer omni_integration_token_xxx',
      'Content-Type': 'application/json'
    },
    body: JSON.stringify({
      attributes: {
        heart_rate_bpm: bpm,
        blood_glucose: glucose
      }
    })
  });
  // Returns 204 No Content
}