API-first DCT platform · Swiss company · EU-hosted
Your whole decentralised trial, in one live view.
Participants stay at home. Their wearables, diaries and consent flow into one audit-trailed record, and our team turns it into the regulatory evidence your study needs.
- ePRO · RPM · eConsent · EDC · CTMS available
- AI Analytics in development
Demonstration study · illustrative figures
- APDC Health Award 2025
- WSA Portugal 2024
- Global Leverage Award 2026 · finalist
- Frontiers Health 2026 · Start-up Discovery, Berlin
- Partners: Analog Devices · Thryve · IPN · TB4Health · APDP · ULS Santa Maria · ULS Coimbra · PCI (Creative Science Park) · Innosuisse · Venturelab
Why now
Two regulatory timelines are moving clinical evidence into the home.
Annex 2 takes effect in the EU
ICH E6(R3) Annex 2
Annex 2 of ICH E6(R3), 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.
ICH E6(R3) Annex 2 readiness assessmentCHF 4,500EU MDR post-market clinical follow-up
EU MDR post-market clinical follow-up obligations push device manufacturers to collect real-world data from devices in use continuously, not episodically.
Post-market surveillance and PMCFPlatform modules
Six modules, one data model. Everything needed to design, run and monitor hybrid and decentralised studies, connected in a single environment. The status of each module is stated on its card.
The product
One record for the investigator and the participant.
Investigators follow vital signs, events and documents per participant. Participants see their own readings and report events from their phone.
Platform screens with placeholder data
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.
Regulatory compliance
Designed for regulated clinical research. The status of each framework is stated as designed to, designed for, in progress or targeted.
ALCOA++
Designed toDesigned to ALCOA++ data-integrity principles. ALCOA++ is a set of principles, not a certification.
EU GDPR
Designed toDesigned to GDPR requirements, with a Data Protection Impact Assessment per study, an Article 28 data processing agreement and EU hosting by default.
HIPAA
Designed for alignmentPlatform architecture designed for HIPAA Administrative, Physical, and Technical Safeguards alignment.
ISO 27001
In progressInformation security management system programme in progress at the application layer.
ISO 13485
In progressQuality management system programme for medical device software in progress; no certificate has been issued to date.
ICH E6(R3) GCP
Designed forArchitecture designed for ICH E6(R3), including Annex 2 on decentralised elements, which takes effect in the European Union on 15 January 2027.
FDA 21 CFR Part 11
Designed forElectronic records and audit trails designed for 21 CFR Part 11; formal validation is planned.
EU MDR
TargetedSoftware as a medical device under EU MDR 2017/745; CE marking targeted for 2028 through a notified body.
Where we work
Land through regulation. Expand by patients.
We work in Portugal and Switzerland today: clinical partners in Portugal, headquarters in Epalinges. The Annex 2 readiness review opens the next markets.
- Now
Portugal · Switzerland
Clinical partners in Lisbon and Coimbra; headquarters in Epalinges.
- 2027
France · Spain · Italy · United Kingdom · Germany · Nordics
ICH E6(R3) Annex 2 readiness reviews for sponsors and CROs with decentralised elements.
- 2028
EU device makers, then the United States
Post-market clinical follow-up and evidence under EU MDR.
Pricing
ICH E6(R3) Annex 2 readiness assessment
CHF 4,500
Credited in full against a platform contract signed within six months.
Request an assessmentOne product, three service levels
- Level 1You run it
- Level 2We run it
- Level 3We bring the hospital
Platform pricing on request; a quotation follows within one week.
See the platform in action
Vitruvian Shield platform overview
Technology, clinical and ecosystem partners
Recognition
- European CEO of the Year 2024-2025Awarded to Paulo Martins
- Portuguese National Innovation Award 2024Awarded to Paulo Martins
- APDC Health Award, First Place 2025
- World Summit Awards Portugal 2024 Winner
- Finalist, Global Leverage Award 2026
- Frontiers Health 2026, Berlin
- Independent expert review completed through IPN healthproof, May 2026
Questions and answers
Frequently asked questions about Vitruvian Shield
What is Vitruvian Shield?
Vitruvian Shield is an AI-native clinical evidence platform for hybrid trials and post-market surveillance. It brings wearable and connected-device data and patient-reported outcomes into one traceable dataset that sits alongside the sponsor's existing EDC. The company is headquartered in Switzerland with entities in Portugal, Armenia and the UAE.
Does Vitruvian Shield replace our EDC?
No. The platform is an evidence layer that works next to the EDC a sponsor already uses, such as Medidata, Veeva or Oracle. Home-collected data carries provenance, identity assurance, a signal-confidence score and an audit trail, and the platform is designed to deliver CDISC and HL7 FHIR exports into that existing stack.
Who uses Vitruvian Shield?
Sponsors running hybrid or decentralised trials, contract research organisations, academic medical centres and hospital research units, and medical device manufacturers who need post-market clinical follow-up and registries. Vitruvian Shield sits in the vendor layer, working under CROs and sponsors.
Which platform modules are available today?
Five modules are available: ePRO, remote patient monitoring, eConsent, electronic data capture and CTMS. AI analytics is in development. Each module page states its own status.
Is Vitruvian Shield certified under ISO 27001, ISO 13485 or CE marked?
No certificate has been issued to date. ISO 27001 and ISO 13485 programmes are in progress, the platform is designed to ALCOA++ data-integrity principles, GDPR, ICH E6(R3) including Annex 2 and FDA 21 CFR Part 11, and CE marking under EU MDR is targeted for 2028 through a notified body. Hosting is on Microsoft Azure in European Union regions.
How do we start working with Vitruvian Shield?
Request a commercial briefing or a demo. Platform pricing is on request and a quotation follows within one week. The ICH E6(R3) Annex 2 readiness assessment, a fixed-scope review priced at CHF 4,500, is a common first step and is credited in full against a platform contract signed within six months.
ICH E6(R3) Annex 2 readiness assessment
- Review of the decentralised elements in your protocol
- Gap list against Annex 2, ranked by inspection risk
- A written report your team can file
30-minute briefing · video call
See your protocol on the platform.
Bring a study you are planning. We map its visits, devices and endpoints live. Briefings in English, French, German, Portuguese and Spanish.
Monday to Friday, 08:00 to 18:00 Zurich time