Data Input Options
Upload Excel files, CSVs, EDC exports, or connect directly to your clinical data warehouse via API. We support CDISC standards (SDTM, ADaM) for seamless integration.
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How It Works
How Genivra Works: Step-by-Step.
From data upload to trial optimization, here's a detailed walkthrough of how our platform transforms your CNS trial strategy with AI-powered insights.
01
Connect Your Data
Begin by securely uploading your trial data, biomarker results, and protocol documentation.
What We Analyze
Protocol details, patient inclusion/exclusion criteria, dosing regimens, primary/secondary endpoints, biomarker data (blood, CSF, imaging), adverse events, and demographics.
Data Security
Your data is encrypted end-to-end (AES-256), stored in HIPAA-compliant infrastructure, and never used to train models accessible to other customers.
Typical Upload Time
Most customers complete data upload in 15-30 minutes. Our team provides hands-on support for complex datasets or legacy systems.
02
AI Analysis
Our AI engine compares your trial against 10,000+ historical CNS studies to identify patterns.
Comparative Analysis
We match your trial against similar studies by indication, mechanism of action, target population, and design characteristics.
Failure Pattern Detection
Our models flag protocol elements historically associated with failure—such as overly broad inclusion criteria, suboptimal endpoints, or inappropriate trial duration.
Success Factor Identification
We identify which elements of successful trials (e.g., specific biomarker thresholds, patient enrichment strategies) are present or absent in your protocol.
Processing Time
Initial analysis completes in 5-10 minutes. Deep biomarker correlation and subgroup analyses may take 30-60 minutes for complex datasets.
03
Generate Insights
Receive actionable recommendations to optimize trial design and reduce failure risk.
Risk Assessment Report
A comprehensive report scoring your trial’s success probability across multiple dimensions (patient selection, endpoint choice, dosing strategy, trial duration).
Protocol Optimization
Data-driven suggestions for modifying inclusion/exclusion criteria, refining endpoints, adjusting dose selection, or implementing biomarker stratification.
Biomarker Insights
Identification of predictive biomarkers that correlate with success in similar trials, including thresholds for patient enrichment or stratification.
Benchmarking
See how your trial compares to industry averages and best-in-class designs for your indication, with specific areas for improvement highlighted.
04
Optimize & Execute
Implement recommendations and continuously monitor trial performance with ongoing support.
Implementation Support
Our clinical development experts help you translate AI insights into protocol amendments, statistical analysis plans, and regulatory submissions.
Ongoing Monitoring
Track your trial’s progress against predictive benchmarks. Our platform flags emerging risks and provides adaptive recommendations.
Iterative Refinement
As new data becomes available (interim analyses, biomarker results), re-run analyses to refine predictions and adjust trial strategy in real-time.
Regulatory Readiness
Generate reports suitable for FDA/EMA submissions, including methodology descriptions, validation evidence, and supporting literature.
Get Started
Ready to Get Started?
See Genivra in action with a personalized demo using your trial data.