Implementation Steps

Clinical & Operational Review: Determine trial objectives, existing workflows, and key biomarkers relevant to your study.

Data Infrastructure Analysis: Identify integration points with EDC systems, internal databases, or any other data capture tools.

Mapping Gene-Drug Panels: Align the relevant PGx markers with your specific protocol (oncology, cardiology, psychiatry, etc.).

System Integration: Establish secure, HIPAA-compliant interfaces (HL7/FHIR) for bidirectional data flow between PGxAI and your EDC/LIMS.

Small-Scale Trial Run: Conduct a mini rollout or simulate patient enrollment to validate setup, check performance, and refine alerts.

Stakeholder Training: Familiarize clinicians, data managers, and coordinators with PGxAI’s interface, AI alerts, and reporting features.

Company-Wide Rollout: Integrate PGxAI insights into live trials, enabling real-time gene-drug interaction checks and personalized dosing recommendations.

Ongoing Support: Access 24/7 assistance, troubleshooting, and updates to address evolving trial requirements or regulatory changes.

Performance Monitoring: Track key metrics—enrollment speed, dropout rates, adverse events, and trial timelines.

Feedback & Iteration: Incorporate user feedback, adjust dosing strategies, and maintain alignment with protocol amendments or new drug-gene insights.

Regulatory Submissions: Leverage PGxAI’s data logs and outcome analyses to strengthen FDA, EMA, or other regulatory agency filings.