The Infrastructure Layer for Decentralized Clinical Trials
API-first platform unifying CTMS, EDC, eConsent, ePRO, and Remote Patient Monitoring in a single compliant environment. Built with Swiss precision for global scale.
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Vitruvian Shield — Exclusive eHealth CTMS & RPM PaaS
One Platform. Six Integrated Modules.
Everything you need to design, execute, and monitor clinical trials, connected in a single regulatory ready environment.
Trusted technology partners
Two Ways to Deploy Vitruvian Shield
Pick the product line that matches your scale and integration posture.
Why Vitruvian Shield
Built different from the ground up, not a collection of acquired tools stitched together, but a unified architecture designed for modern clinical research.
Device-Agnostic
Integrate data with broad device coverage across clinical grade and consumer wearables, with direct medical grade integrations for continuous ECG, EEG, multi parameter vital signs, and camera based contactless vital sign monitoring via rPPG technology. No vendor lock-in, swap devices mid study without disrupting data continuity or compliance.
AI-Native Architecture
Machine learning isn't bolted on, it's woven into the platform core. From predictive enrollment forecasting to real-time adverse event detection, every module benefits from intelligent automation.
Regulatory Ready from Day One
Pre-validated against ICH E6(R3) GCP, EU GDPR, HIPAA, and FDA 21 CFR Part 11. Continuous compliance monitoring ensures your trial stays audit ready throughout its lifecycle.
AI-Native From the Core
Vitruvian Shield is built AI-native from the core. Not a roadmap overlay. Three capabilities are in active development for Q2 2026 early access with design partners.
AI Questionnaire Builder
Describe the questionnaire you need in plain language. Our AI-assisted builder generates the electronic CRF structure, validation rules, and skip logic. In active development, early access Q2 2026 for design partners.
AI Voice Assistant
Patient-facing voice guidance through study protocols, designed to reduce investigator burden and increase diary compliance. In validation with pilot sites.
AI Symptom Checker
Patient triage classification with real-time escalation to investigators for urgent symptom profiles. In development.
Clinical AI on a disciplined timeline
Clinical-decision-support AI (seizure prediction, hypoglycemia forecasting, cardiac arrhythmia detection) is held on a 2027-2029 timeline, explicitly gated on 500+ patients and 6-12 months of longitudinal data per indication. We do not ship clinical AI before the evidence is there.
The global decentralized clinical trial market is projected to grow from USD 8.8 billion in 2024 to USD 18.8 billion by 2030, at a 13.7 percent compound annual growth rate.
Source: BCC Research, March 2026
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Team members across Switzerland, Portugal, Armenia, and the UAE
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Integrated clinical platform modules
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Regulated jurisdictions of operation
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Therapeutic areas in active clinical development
Regulatory Compliance
Built to meet the highest standards of clinical research and data security.
ALCOA++
CompliantData integrity principles for attributable, legible, and complete records.
HIPAA
Designed for HIPAA alignmentPlatform architecture designed for HIPAA Administrative, Physical, and Technical Safeguards alignment.
EU GDPR
CompliantFull compliance with European data protection regulation, with study-specific Data Protection Impact Assessments and documented cross-border transfer mechanisms under Standard Contractual Clauses.
ISO 27001
In progressInformation security management system certification.
ISO 13485
In progressQuality management system for medical device manufacturing.
ICH E6(R3) GCP
PlannedGood Clinical Practice guidelines for international clinical trials.
FDA 21 CFR Part 11
PlannedElectronic records and signatures regulation for FDA submissions.
EU MDR
PlannedEuropean Medical Device Regulation for clinical software.
Advancing Research Across Therapeutic Areas
Purpose built workflows and validated outcome measures tailored to the unique demands of each therapeutic domain.
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Choose the path that fits your organization. Each route goes directly to the right internal owner.