Built for Pharma Sponsors
Reduce trial timelines by months, cut monitoring costs by 40%, and maintain real-time audit readiness across your entire portfolio.
The Challenges You Face
Fragmented Technology Stacks
Managing separate vendors for CTMS, EDC, eConsent, ePRO, and RPM creates data silos, integration overhead, and compliance gaps between systems.
Slow Enrollment & High Dropout
Traditional site-based models limit your recruitment pool and burden patients with frequent clinic visits, driving dropout rates above 30% in many indications.
Rising Monitoring Costs
On-site monitoring visits consume 25–30% of trial budgets. Manual source data verification is slow, expensive, and still misses critical data quality issues.
Regulatory Complexity
Navigating FDA, EMA, and local authority requirements across multi-region trials requires constant vigilance and manual compliance tracking.
Limited Real World Data Capture
Episodic clinic-based assessments miss the continuous patient experience between visits, leaving gaps in safety signals and efficacy evidence.
How Vitruvian Shield Helps
Unified Platform, Zero Silos
Replace 5–7 point solutions with a single integrated platform. Data flows automatically between modules, no middleware, no manual reconciliation, no compliance gaps.
Decentralized Trial Capabilities
Remote consent, home-based monitoring, and mobile ePRO let patients participate from anywhere. Reduce site dependency and expand your enrollment reach.
Risk Based Monitoring Built In
AI powered centralized monitoring replaces costly on site visits. Automated data quality scoring, protocol deviation detection, and targeted site alerts.
Continuous Compliance
Pre-validated against ICH E6(R3), GDPR, HIPAA, and FDA 21 CFR Part 11. Automated audit trails and compliance dashboards keep every study inspection-ready.
Continuous Data Capture
Broad device coverage streams real world patient data 24/7 through direct medical grade integrations for continuous ECG, EEG, multi parameter vital signs, and camera based contactless monitoring via rPPG. Capture safety signals, treatment response, and quality of life metrics between visits.
Let's Talk
Choose the path that fits your organization. Each route goes directly to the right internal owner.