Built for the Most Demanding Regulatory Environments

Every data point in Vitruvian Shield satisfies ALCOA++ data integrity principles. Attributable (who created it), Legible (clearly readable), Contemporaneous (recorded at time of activity), Original (first-capture source), Accurate (correct and verified), plus Complete, Consistent, Enduring, and Available. Automatic audit trails, timestamping, and reason for change capture ensure unbroken data provenance.

Platform architecture is designed for HIPAA Administrative, Physical, and Technical Safeguards alignment, including minimum-necessary access, protected health information de-identification pathways, and comprehensive audit logging. Business Associate Agreement program and United States Security Rule attestation are part of our US market expansion roadmap.

Full compliance with the European General Data Protection Regulation, including lawful basis management for clinical trial data processing, data subject rights workflows, Data Protection Impact Assessment documentation, cross-border transfer mechanisms (SCCs), data minimization controls, purpose limitation enforcement, and automated breach notification workflows. Privacy-by-design is embedded in every feature, with study-specific Data Protection Impact Assessments and documented cross-border transfer mechanisms under Standard Contractual Clauses.

Our Information Security Management System follows ISO 27001 framework requirements. We implement comprehensive risk assessment processes, security controls across all 14 domains, continuous monitoring and incident response, and management review cycles. Third-party certification audit is in progress.

Our development processes follow ISO 13485 quality management system requirements for medical device software. This includes design and development controls, risk management per ISO 14971, traceability from user requirements through verification and validation, CAPA processes, and supplier quality management for all third party components.

Vitruvian Shield is architected around the latest ICH E6(R3) Good Clinical Practice guidelines. Our platform supports risk-proportionate approaches to trial oversight, technology enabled participant engagement, and quality-by-design principles. Every module, from eConsent to RPM. implements the R3 emphasis on participant centric, digitally native trial processes with built in quality tolerance limits and centralized monitoring capabilities.

Full compliance with FDA electronic records and signatures regulation. Includes validated electronic signatures with two-factor identity verification, complete audit trails with timestamp and reason for change, system access controls with unique user credentials, authority checks for signature privileges, and document lifecycle management with version control and archival.

Vitruvian Shield is designed in accordance with European Medical Device Regulation requirements for clinical decision support software. Our quality management system, risk management processes, clinical evaluation procedures, and post market surveillance frameworks align with EU MDR Annex I essential safety and performance requirements for Class IIa medical device software.