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.
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.
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.
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
Questions and answers
Platform questions
What does the Vitruvian Shield platform include?
Six modules on one data model: ePRO (available), remote patient monitoring (available), eConsent (available), electronic data capture (in development), AI analytics (in development) and CTMS (roadmap). A device compatibility matrix lists every supported wearable and its status.
How does data get from a wearable into the study dataset?
Devices are activated per study. The Analog Devices Study Watch is integrated natively; the Dexcom G7 CGM, Corsano CardioWatch and X-trodes dry-electrode EEG arrive through Thryve aggregation; camera-based contactless vital signs (rPPG) are in validation. Every record carries provenance, identity assurance, a signal-confidence score and an audit trail.
Does the platform integrate with Medidata, Veeva or Oracle?
Yes, through the CONNECT integration layer, which plugs wearables, biosignal streams and decentralised study modules into existing enterprise clinical stacks. The platform sits alongside the sponsor's EDC and is designed to deliver CDISC and HL7 FHIR exports.
Where is study data hosted?
On Microsoft Azure in European Union regions by default, with regional data residency available on request. Hosting suppliers' certifications are not presented as the company's own.
What role does AI play in the platform?
An AI-assisted questionnaire and CRF builder is in development and an AI accessibility assistant for patients completing questionnaires is in validation. Clinical AI is held on a 2027 to 2029 timeline; the company does not ship clinical AI before the evidence is there.
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Talk to us about your next study.
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