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Overview

Streamline Clinical Trials with Seamless Technology & Workflow Integration

Merge PGx insights directly into your trial data systems, empowering CROs and sponsors to make smarter decisions in real time.
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Overview
Clinical research hinges on efficient data management and rapid, evidence-based decision-making. PGxAI’s Technology & Workflow Integration ensures that critical pharmacogenomic insights flow seamlessly alongside patient data in your Electronic Data Capture (EDC) systems, Laboratory Information Systems (LIMS), and analytics platforms. This unified approach helps your teams pinpoint genetic risks and optimize therapies without disrupting established trial processes—ultimately boosting precision, compliance, and trial success rates.
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Interoperable with Popular EDCs: Medidata Rave, Oracle Clinical, REDCap, and more
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Built on InterSystems IRIS for Health: Ensuring scalable data throughput and real-time analytics
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HIPAA & SOC 2 Compliance: Secure handling of PHI across global trial sites
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Adaptive Integration: Tailored to Phase I–III and post-marketing studies, adapting to evolving protocol needs
Key Features
Serving every stakeholder in healthcare
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EDC Compatibility
Easily exchange patient data, lab results, and genetic markers through HL7/FHIR-based interfaces
Automatic push/pull of PGx insights into your chosen EDC forms
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Real-Time Alerts & Dashboards
Automated flagging of gene-drug interactions, dosing adjustments, or adverse event risks
Custom views for clinicians, data managers, and project leads
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Automated Workflow Tools
Pre-screening for genetic eligibility criteria
Streamlined randomization and dose-escalation decisions powered by PGx-driven algorithms
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Secure, Scalable Infrastructure
End-to-end encryption for all trial data
Horizontal scaling to accommodate multi-site trials and large patient cohorts without performance bottlenecks
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24/7 Support & Training
Dedicated specialists assist your teams with setup, user onboarding, and ongoing best practices
Regular updates to keep your integration aligned with evolving clinical and regulatory standards
Integration
Real-World Use Cases
Merge PGx insights directly into your trial data systems, empowering CROs and sponsors to make smarter decisions in real time.
1. Assessment
• Review your existing EDC setup, data workflows, and trial objectives
• Plan integration approach based on protocol phase, sample size, and trial design
2. Configuration & Pilot
• Implement HL7/FHIR interfaces and map PGx data points to your EDC fields
• Conduct a test run with a small cohort or single site
3. Full Deployment
• Extend PGxAI insights across all participating sites
• Train key personnel on interpreting gene-drug recommendations and addressing flagged alerts
4. Ongoing Optimization
• Monitor system performance and user feedback
• Evolve the platform to handle updated inclusion/exclusion criteria, emerging biomarkers, or new protocols
Benefits
Benefits for CROs & Sponsors
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Reduced Manual Tasks
Automatic data exchange eliminates re-entry errors and speeds up trial operations
Improved Compliance
Seamless documentation of genetic rationale for protocol amendments or safety measures
Faster Interim Analyses
Real-time AI-driven insights enable timely modifications to trial arms or dosing regimens
Stronger Competitive Edge
Sponsors gain confidence in your ability to run data-driven, high-fidelity trials
Whats next
Elevate Your Clinical Research Workflows
Contact Our CRO Team
Collaborate on a pilot integration tailored to your trial requirements
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Request a Demo
See how PGxAI integrates with your preferred EDC or analytics platform
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Learn More
Explore how our scalable, secure infrastructure supports complex, multi-site clinical studies
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