Vitruvian Shield
Platform

One platform for home-collected clinical evidence

Wearable and connected-device data and patient-reported outcomes are brought into one traceable dataset that sits alongside the sponsor's existing EDC, designed to ALCOA++ data-integrity principles and GDPR requirements.

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How we fit

Three layers run a study. Vitruvian Shield sits in the third.

Sponsors

Own the study and the EDC.

CROs

Run the study.

Vendors

Supply the evidence layer. Vitruvian Shield sits here, working under CROs and sponsors.

API-first architecture

One API. Six modules. A unified data model.

A central API that orchestrates every module. CTMS, EDC, eConsent, ePRO, RPM, and AI all speak a single schema and share a single audit trail.

Hover a module to pause its orbit and see its name. Click to navigate to the module page.

  • One developer experience across every module
  • Data flows both ways — no silos, no custom middleware
  • Audit-trail evidence exported from one place

Illustrative visualisation. Module availability shown in the module grid below.

API

What we build first

The first module we are building is the evidence layer: continuous home-collected data with provenance, identity assurance, a signal-confidence score and an audit trail, designed to deliver CDISC and HL7 FHIR exports, attached to the sponsor's existing EDC. The protocol engine follows.

The platform sits alongside the sponsor's existing EDC rather than replacing it.

Platform modules

Six modules, one data model. Data entered once propagates everywhere it is needed, and the status of each module is stated on its card.

Roadmap

CTMS

Clinical Trial Management System for end-to-end study planning, site management, and milestone tracking.

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Roadmap

EDC

Electronic Data Capture with intelligent forms, real-time validation and a full audit trail.

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Roadmap

eConsent

Digital informed consent with multimedia support, version control, and remote signing capabilities.

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Roadmap

ePRO

Electronic Patient Reported Outcomes with adaptive questionnaires and real-time symptom monitoring.

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Roadmap

Remote Patient Monitoring

Device-agnostic wearable integration with continuous vital signs streaming and alert automation.

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Roadmap

AI Analytics

Machine learning models for predictive enrollment, adverse event detection, and protocol optimization.

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Devices: native plus on demand

Integration follows a native-plus-on-demand model: one native research wearable, and further devices activated per study through our aggregation partnership with Thryve.

Native research wearable

The Analog Devices Study Watch is the platform's native research wearable, integrated directly for heart rate, heart rate variability and ECG.

Activated per study

Dexcom G7 (consumer API live, clinical-grade authorisation in progress), Corsano CardioWatch and X-trodes dry-electrode EEG are activated per study through Thryve. Camera-based contactless vital signs (rPPG) are in validation.

All sources feed the same normalised data pipeline with provenance, signal-confidence scoring and automated quality flagging.

API-First Architecture

Every feature in Vitruvian Shield is accessible through documented, versioned RESTful APIs.

Comprehensive REST API

Full CRUD operations across all modules with OAuth 2.0 authentication and role based access control.

Webhook Event System

Real-time event notifications for study milestones, data changes, safety alerts, and compliance triggers.

FHIR R4 Compatibility

HL7 FHIR R4 resource mapping for health data interchange with EHR and hospital systems.

CDISC ODM/Dataset-JSON

Export in CDISC standards, designed for regulatory submission packages and data interchange.

See the platform in action

Vitruvian Shield Mobile App

Patient-facing iOS and Android companion app for remote monitoring and ePRO capture.

Ready to Modernize Your Clinical Trials?

Talk to us about your next study.

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Or contact our team for a personalized walkthrough.