How does PGxAI integrate with our existing EDC platforms?
PGxAI offers standardized HL7/FHIR-based interfaces, making it compatible with leading EDC systems like Medidata Rave, Oracle Clinical, REDCap, and more. Our implementation specialists guide you through setup and ensure a seamless data flow between your trial databases and the PGxAI engine.
Which phases of clinical trials does PGxAI support?
Our platform is designed for all phases—I through IV. From dose-finding and safety monitoring in early phases to large-scale efficacy validation and post-marketing surveillance, PGxAI tailors insights to each stage of drug development.
Is patient data secure on PGxAI?
Yes. We adhere to HIPAA and SOC 2 standards, implementing end-to-end encryption, access controls, and robust audit logs. Our partnership with InterSystems IRIS for Health also ensures high-performance data handling with full compliance.
Can PGxAI help with patient recruitment and stratification?
Absolutely. PGxAI’s genetic marker analysis aids in identifying the most suitable patients for your study, increasing enrollment speed and minimizing dropouts due to adverse events.
Does PGxAI provide real-time alerts for drug-gene interactions?
Yes. Once integrated with your EDC or trial management system, PGxAI issues automated flags when specific gene variants indicate potential safety concerns or dosing adjustments.
Does PGxAI generate insights usable for regulatory submissions?
Yes. PGxAI captures detailed, timestamped logs of genomic analyses, recommendations, and outcomes. These data points can strengthen your filings with bodies like the FDA or EMA, demonstrating a robust, evidence-based approach.
Can we pilot or customize the platform for unique study protocols?
We encourage pilot projects. Our team works closely with CROs to tailor PGx modules, integration workflows, and reporting templates to align with specific therapeutic areas or trial designs.
What kind of training or support does PGxAI provide?
Your team receives comprehensive onboarding, including virtual workshops and documentation. We also offer 24/7 technical support and periodic platform updates to keep pace with evolving clinical and regulatory requirements.