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.
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
Template: Remote Wearable Device
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
Template: Trial Participant
Template: Trial Participant
Template: Trial Participant
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
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}/metrics`;
await fetch(url, {
method: 'POST',
headers: {
'Authorization': 'Bearer omni_integration_token_xxx',
'Content-Type': 'application/json'
},
body: JSON.stringify({
attribute_values: [
{ attribute_id: "heart_rate_bpm", value: bpm },
{ attribute_id: "blood_glucose", value: glucose }
]
})
});
// Returns 202 Accepted
} Further Reading
Learn more about how Omnismith handles data isolation and project scopes to ensure enterprise-grade security for sensitive information.
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Clone Clinical Trial BlueprintQuestions about PII isolation? hello@omnismith.io