Self-assessed evaluation
Preliminary self-assessed evaluation by the clinical expert against the Vitruvian Shield product dossier and supporting material.
Trust Portal · Independent KOL Validation
Independent clinical KOL validation
Vitruvian Shield was assessed by an independent clinical expert through Instituto Pedro Nunes, under the IPN healthproof Develop, Validate, Comply discipline.
Report Final v1.0 · 14 pages · completed 2026-05-28. Identity of the independent clinical KOL is withheld in accordance with the report's anonymity provisions.
Independent Clinical Validation
Vitruvian Shield underwent independent clinical KOL validation through Instituto Pedro Nunes, the Portuguese research and innovation institute, under the IPN healthproof framework. The assessment was finalised on 28 May 2026 as a 14-page report, version Final v1.0.
IPN healthproof operates under the Develop, Validate, Comply discipline applied to health technologies in Portugal. The validation was conducted by an independent clinical KOL whose identity is withheld in accordance with the report's anonymity provisions. The KOL is referred to throughout this surface as the independent clinical KOL or the clinical expert.
The unredacted report remains the property of Instituto Pedro Nunes and is available to investors and qualified institutional partners under non-disclosure on request, through the request form in the Download and request section below.
Validation methodology
Guided 1:1 meeting
One-to-one guided meeting following a product demonstration, covering clinical relevance, technological differentiation, SWOT analysis, adoption pathways, and impact metrics.
Expert assessment report
Consolidated expert assessment report, version Final v1.0, signed by the independent clinical KOL.
Verdict
The validation concluded that Vitruvian Shield is a clinically valuable and strategically promising platform for decentralized and hybrid clinical research. The assessment confirms the platform addresses real pain points in current clinical trial workflows, including patient travel burden, dropout risk, fragmented digital tools, underreporting of symptoms between visits, manual data entry, limited real-time visibility, and the absence of continuous real-world data capture.
The strongest value proposition identified by the clinical expert lies in the combination of a unified clinical research platform, electronic patient-reported outcomes, patient event reporting, wearable and rPPG-based physiological data, electronic documentation, role-based governance, multilingual patient interaction, and modular API deployment.
The clinical expert noted that this combination is particularly relevant for academic centres and medium-sized research organisations that do not have access to enterprise-grade decentralized clinical trial infrastructure.
The oncology use case was identified as an especially credible initial clinical validation pathway.
SWOT
Reproduced from the report's Final Assessment in anonymised form. Quadrants render in a two-by-two grid; items inside each quadrant are kept compact.
Strengths
- Unified platform combining CTMS, EDC, eConsent, ePRO, RPM, document management, patient communication and data-capture functions
- Clinically meaningful support for decentralized and hybrid trials
- Prospective symptom and adverse-event reporting that reduces recall bias
- Remote monitoring that may reduce patient travel burden and dropout
- Usefulness for real-world evidence and post-marketing studies
- Portuguese-language and multilingual support with voice-based AI interaction
- Wearable and rPPG integration
- Role-based access and audit trail logic
- Modular API deployment compatible with REDCap and existing CTMS or EDC stacks
- Option of national or hospital-based data hosting
Weaknesses
- Early stage of clinical adoption without large-scale published implementation evidence
- Absence of peer-reviewed comparative studies against standard workflows
- Ongoing certification and regulatory maturation requirements, particularly for AI, RPM and SaMD functions
- Digital-literacy barriers in older or frailer patient populations
- Need for initial training and protected implementation time on the clinical side
- Some integrations not yet fully production-mature
- Dependence of clinical value on careful workflow configuration
Opportunities
- Investigator-initiated studies at academic hospitals without dedicated DCT infrastructure
- Oncology as a high-potential entry indication
- Chronic disease management more broadly, including neurology, cardiology, diabetes, respiratory and metabolic conditions
- Remote and geographically dispersed populations
- Phase III and IV observational and post-marketing studies
- Multicentric studies benefiting from harmonised data capture
- Early free or low-cost institutional pilots generating evidence that supports future procurement and investment
Threats
- Evolving regulatory requirements for AI and SaMD
- Ethics committee, DPO and hospital IT review delays
- Competition from established global platforms with brand recognition and procurement relationships
- Clinician resistance to perceived administrative overhead
- Limited clinical credibility until peer-reviewed publications and multicentre data are available
- Cost sensitivity in public hospitals and academic studies
- Reputational risk from any false expectations of AI autonomy
Recommendations and our response
The ten recommendations from the report, paired with Vitruvian Shield's published response for each.
Recommendation 1
Start with focused investigator-initiated pilots.
Our response
The Vitruvian Academic Research Program launched in May 2026 in Portugal is the formal vehicle for investigator-initiated pilots, providing a 12-month royalty-free institutional license with 100 GB per study per calendar year and a single Institutional Administrator model.
Recommendation 2
Prioritize oncology and chronic disease use cases.
Our response
Oncology and chronic disease are the two indications prioritised in the active Portuguese clinical pipeline.
Recommendation 3
Define workflow ownership before deployment.
Our response
The platform's role-based access control enforces workflow ownership at protocol level and is documented in the Trust Portal.
Recommendation 4
Measure impact using operational and data-quality metrics.
Our response
The academic license contractually commits each pilot to track operational and data-quality metrics including dropout rate, avoided in-person visits, data-entry time, query and correction rate, ePRO completion rate, time from event occurrence to reporting, and patient and caregiver usability.
Recommendation 5
Design for older and digitally less confident patients.
Our response
The AI voice assistant is in active validation with pilot sites for exactly this purpose, with caregiver-assist workflows on the Q4 2026 roadmap.
Recommendation 6
Generate independent validation evidence.
Our response
The Academic Program is engineered as a peer-reviewed publication pipeline with co-authorship under ICMJE criteria and a Publications page on this website tracking every output.
Recommendation 7
Document regulatory and data-protection boundaries.
Our response
This Trust Portal is the public expression of that documentation, with DPA template, DPIA template, sub-processor list, data-residency map, audit-trail specification, validation summary, vulnerability disclosure policy and certification roadmap published and downloadable.
Recommendation 8
Offer modular deployment for mature centres.
Our response
Vitruvian Shield CONNECT is the productised modular API integration layer for institutions already operating Medidata, Veeva, Oracle or REDCap.
Recommendation 9
Prepare an ethics and DPO briefing pack.
Our response
An Ethics and DPO briefing pack is available to institutional partners on request and is also bundled in the Academic Program onboarding kit.
Recommendation 10
Build an ROI narrative for hospitals and sponsors.
Our response
An ROI evidence pack is being assembled with anonymised data from the Academic Program pilots and will be published as a quarterly Vitruvian DCT Economics report starting Q4 2026.
Download and request
Two paths: download the Vitruvian Shield anonymised Validation Summary, or request the unredacted IPN report under non-disclosure.
Validation Summary PDF
A Vitruvian Shield-produced summary covering methodology, verdict, SWOT and the ten recommendations with our responses, in anonymised form. Available behind a short identification form.
Request the Summary PDF
Unredacted IPN report (NDA)
The full 14-page IPN report, version Final v1.0, available to investors and qualified institutional partners under non-disclosure. Requests are reviewed within five business days.
Request the Unredacted Report (NDA)
Identity of the independent clinical KOL is withheld in accordance with the validation report's confidentiality provisions. IPN and IPN healthproof are named as the validation framework provider; they are the institutional process, not the KOL.