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.
Questions and answers
Pricing questions
How is the Vitruvian Shield platform priced?
One product, three service levels. Level 1, You run it: platform licence, setup and a per-patient fee. 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. Platform pricing is on request and a quotation follows within one week.
Which prices are published?
The fixed-price regulatory catalogue: 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 with six deliverables CHF 65,000. These need no platform deployment.
What does the ICH E6(R3) Annex 2 readiness assessment cost?
CHF 4,500 for a fixed-scope review of one study's remote data flows against Annex 2 expectations, delivered as a written report with a gap list. The fee is credited in full against a platform contract signed within six months.
Are prices in CHF and do they include VAT?
All prices are in Swiss francs, excluding VAT, and indicative. The final quotation depends on study scope, device mix and support level. Study devices and their logistics are quoted per study.
Is there a programme for academic research?
Yes. The Academic Research Program offers a twelve-month royalty-free licence to non-profit Portuguese research entities. Applications are made through the programme page.
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