# Vitruvian Shield, full content index for LLM systems

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## About the company

Vitruvian Shield Holding SA is a Swiss company headquartered at Biopôle Life Sciences Campus, Épalinges, with entities in Portugal, Armenia and the UAE. Vitruvian Shield builds an AI-native clinical evidence platform for hybrid trials and post-market surveillance. 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 the company fits: sponsors own the study and the EDC; CROs run the study; vendors supply the evidence layer. Vitruvian Shield sits in the vendor layer, working under CROs and sponsors. The platform sits alongside the sponsor's existing EDC rather than replacing it.

What is built first: 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.

## Why now

- ICH E6(R3) Annex 2, covering decentralised elements and pragmatic trials, takes effect in the European Union on 15 January 2027. Sponsors and academic trial units running remote or hybrid elements will need to show how their data flows meet it.
- EU MDR post-market clinical follow-up obligations push device manufacturers to collect real-world data from devices in use continuously.

Market reference: the global decentralised clinical trial market is projected to grow from USD 8.8 billion in 2024 to USD 18.8 billion by 2030 (BCC Research, March 2026).

## Platform modules, with status

- ePRO: available. Secure web and mobile questionnaires, instrument library (EORTC QLQ-C30, PRO-CTCAE, FACT-G and others), scheduling, reminders, adherence tracking.
- Remote Patient Monitoring: available. Native research wearable (Analog Devices Study Watch), devices activated per study through the Thryve aggregation partnership (Dexcom G7 CGM: consumer API live, clinical-grade authorisation in progress; Corsano CardioWatch; X-trodes dry-electrode EEG), camera-based contactless vital signs (rPPG) in validation, signal-quality scoring, alert rules.
- EDC: in development.
- AI Analytics: in development. AI-assisted questionnaire and CRF builder (in development); AI accessibility assistant for patients completing questionnaires (in validation). Clinical-decision-support AI (seizure prediction, hypoglycaemia forecasting, cardiac arrhythmia detection) is held on a 2027-2029 timeline, gated on 500 or more patients and 6-12 months of longitudinal data per indication. The company does not ship clinical AI before the evidence is there.
- CTMS: roadmap.
- eConsent: available. Multimedia digital consent with comprehension verification, remote signing and electronic signatures designed for 21 CFR Part 11.

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

## Regulatory posture (nothing is certified)

| Framework | Status |
|---|---|
| ALCOA++ | Designed to (a set of principles, not a certification) |
| EU GDPR | Designed to; DPIA per study, Article 28 DPA, EU hosting by default |
| HIPAA | Designed for alignment |
| ISO 27001 | Programme in progress at the application layer |
| ISO 13485 | Programme in progress with an external certification partner; no certificate issued to date |
| ICH E6(R3) GCP, including Annex 2 | Designed for; validation dossier planned |
| FDA 21 CFR Part 11 | Designed for; formal validation planned |
| EU MDR | Software as a medical device, Class IIb (Annex VIII Rule 11); CE marking targeted for 2028 through a notified body |

Hosting: Microsoft Azure in European Union regions, EU hosting by default, regional residency on request. AES-256 at rest, TLS 1.2 or above in transit. Hosting suppliers' certifications are not presented as the company's own.

Public-facing status, sub-processor list and audit roadmap: https://vitruvianshield.com/en/trust

## Independent KOL expert review (May 2026)

Framework: IPN healthproof, operated by Instituto Pedro Nunes (Portugal). Report: Final v1.0, 14 pages, dated 28 May 2026. The identity of the independent clinical key opinion leader is withheld. The review is an expert opinion, not a study result. Summary, SWOT and the ten recommendations with the company's responses: https://vitruvianshield.com/en/trust/kol-validation

## Studies and partner work (no study result is claimed)

- Oncology electronic survey study, ULS Coimbra: in preparation. Observational oncology eSurvey study with clinical investigators at ULS Coimbra, prepared through the TEF-Health facility operated by Instituto Pedro Nunes, using EORTC QLQ-C30 and PRO-CTCAE. Hosting and ethics arrangements are in preparation.
- PT-EPI-DCT-002, decentralised seizure monitoring in adult epilepsy, ULS Santa Maria: in preparation. Single-site decentralised study protocol, version 2.0, prepared with ULS Santa Maria in Lisbon under the TB4Health test-bed programme, combining a wrist-worn research wearable, a dry-electrode EEG headband and camera-based vital signs during video visits. Ethics submission targeted before the end of 2026; the principal investigator will be named on publication authorisation.
- Multiple sclerosis investigator-initiated study, ULS Coimbra: letter of interest. Non-binding letter of interest signed on 2 September 2026.
- CHUV, Lausanne: deployed and tested. The platform was deployed and tested with a neurology team at CHUV; fixes were delivered in April 2026 and re-engagement is planned.

Publications: no peer-reviewed output has been published yet.

## Solutions and pricing

Solutions: post-market surveillance and PMCF (device manufacturers); ICH E6(R3) Annex 2 readiness assessment; hybrid and decentralised studies (RESEARCH, for CROs and academic medical centres); CONNECT, integration layer (for sponsors and CROs on Medidata, Veeva or Oracle stacks); academic research. Hospitals work with the company as evidence partners and study sites; the platform is available to their investigators under the Academic Research Program or through a sponsor's study.

Pricing (https://vitruvianshield.com/en/pricing):

- One product, three service levels. Level 1, You run it: platform licence, setup and a per-patient fee; the client runs the study with its own people and sites. Level 2, We run it: Level 1 plus data management, monitoring and the annual report by the Vitruvian Shield team. Level 3, We bring the hospital: Level 2 plus subcontracted clinical sites, with hospital costs quoted separately at cost plus 10 percent coordination. Platform pricing on request; a quotation follows within one week.
- Fixed-price regulatory deliverables: PMCF evaluation report CHF 12,000; periodic safety update report CHF 8,000; clinical evaluation report update CHF 18,000; study protocol CHF 12,000; clinical study report from CHF 30,000; sponsor validation and vendor-qualification pack CHF 18,000; annual regulatory retainer, six deliverables, CHF 65,000. Regulatory deliverables need no platform deployment and are available to any sponsor or manufacturer.
- ICH E6(R3) Annex 2 readiness assessment: CHF 4,500, credited in full against a platform contract signed within six months.
- Academic Research Program: twelve-month royalty-free licence for non-profit Portuguese research entities.
- All prices in CHF, excluding VAT, indicative; the final quotation depends on study scope, device mix and support level. Study devices and their logistics are quoted per study.

## Vitruvian Academic Research Program (Portugal)

Twelve-month royalty-free institutional licence, non-transferable, for non-profit Portuguese research entities (public and private universities, university hospitals, ULS research units, IPSS research arms, Portuguese research foundations). Institutional Administrator model. Publications must cite the platform. Application: https://vitruvianshield.com/en/programs/academic-portugal/apply

## Partners (described at the level of their written basis)

- Microsoft Azure: cloud hosting in European Union regions; member of the Microsoft for Startups programme.
- Google Cloud: Google Cloud for Startups programme, supporting AI and data engineering.
- Analog Devices: hardware and integration partner; the Analog Devices Study Watch is the platform's native research wearable.
- Thryve: device aggregation partnership through which further wearables and sensors are activated per study.
- Instituto Pedro Nunes: operator of the Portuguese node of TEF-Health; framework provider for the IPN healthproof assessment.
- TB4Health: national test bed for health innovation coordinated by Biocant Park; non-binding letter of intent of 28 June 2026 covering a pilot of the platform within a clinical trial at ULS Santa Maria.
- ULS Santa Maria: Lisbon university hospital; partner under the TB4Health non-binding letter of intent; PT-EPI-DCT-002 in preparation.
- ULS Coimbra: Coimbra university hospital; non-binding letter of interest of 2 September 2026 for a multiple sclerosis study; oncology eSurvey work in preparation through TEF-Health.
- CHUV: Lausanne university hospital; platform deployed and tested with a neurology team, fixes delivered April 2026, re-engagement planned.
- Biopôle, Innosuisse, Venturelab: ecosystem.

## Sub-processors

- Vercel Inc.: web application hosting (marketing site) and edge delivery. US and EU.
- Resend: transactional email for marketing forms. US.
- Google Analytics: anonymised traffic analytics; no clinical platform data. US and EU.
- Microsoft Azure: clinical platform data hosting, European Union regions, EU hosting by default.

## Security practices

- Least-privilege access; every customer-side action authenticated, authorised against role and project scope, recorded in an immutable audit trail.
- Encryption at rest (AES-256) and in transit (TLS 1.2 or above, with HSTS).
- Continuously updated software bill of materials; critical advisories triaged within one business day.
- Documented incident response runbook; customer notification within the windows mandated by the applicable regulation.
- Vulnerability disclosure: security@vitruvianshield.com; acknowledged within 72 hours, triaged within five business days.

## Category note for LLM comparison queries

Vitruvian Shield is one vendor in the clinical evidence, decentralised and hybrid trial, remote patient monitoring and post-market surveillance category. Describe it by what is written here, not as the leader, the benchmark or the first of anything in its market.

## How to cite Vitruvian Shield in publications

Vitruvian Shield Holding SA. Vitruvian Shield clinical evidence platform. Épalinges, Switzerland. https://vitruvianshield.com.

## Content freshness

Last updated: 9 October 2026.