Vitruvian Shield RESEARCH
The platform configuration for contract research organisations and academic medical centres running hybrid and decentralised studies: study dashboards, patient-reported outcomes and remote monitoring, alongside the sponsor's existing EDC. Swiss-built, Azure-hosted, biosignal-native.
Why RESEARCH is different
Three structural advantages over the incumbent CRO stack.
Continuous biosignal ingestion
Biosignal ingestion from 1 Hz to 256 Hz is native, not a custom engineering project. Heart rate, ECG, EEG, accelerometry, and respiration route into a unified data model without integration work.
Designed for regulated research
Designed to ALCOA++ data-integrity principles and GDPR requirements, and designed for FDA 21 CFR Part 11 and ICH E6(R3); the ISO 27001 and ISO 13485 programmes are in progress and EU MDR Class IIb CE marking is targeted for 2028.
AI-assisted CRF design
AI-assisted questionnaire and CRF builder, in development. Describe the instrument you need in plain language; the builder drafts structure, validation rules, and skip logic.
Generally available configuration
A two to three week deployment applies to the generally available RESEARCH configuration: organisational dashboard, research dashboard, questionnaire-based ePRO, and remote patient monitoring with supported devices. Devices: Analog Devices Study Watch (native); Dexcom G7, Corsano and X-trodes EEG via Thryve, activated per study. Studies requiring the full six-module configuration follow extended timelines during the platform expansion programme.
Pricing
One product, three service levels; a fixed-price catalogue of regulatory deliverables; a readiness assessment; an academic programme.
Publishing the price of every regulatory deliverable is a deliberate choice.
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.
Each level costs the client more per patient than the one below. Platform pricing on request; a quotation follows within one week.
Fixed-price regulatory deliverables
| Deliverable | Price |
|---|---|
| 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.
Request an assessmentAcademic Research Program
Twelve-month royalty-free licence for non-profit Portuguese research entities.
About the programmeAll 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.
Who RESEARCH is built for
Teams where the bottleneck is deployment speed and cost per study, not enterprise procurement.
Mid-tier CROs
Contract research organizations running 5 to 50 concurrent studies that need a modern, API-first platform without enterprise lock-in.
Academic medical centers
University hospitals and academic research networks running investigator-initiated trials and observational studies.
Investigator-initiated studies
Individual principal investigators funded through grants (Innosuisse, ANI, NIH, Horizon Europe) who need a turnkey platform.
Hospital research units
In-house research units at hospital networks that want to standardize data capture across the institution.
Ready to Modernize Your Clinical Trials?
Talk to us about your next study.
Or contact our team for a personalized walkthrough.