Case Studies
Cardiology Programs
Novel Anticoagulant (DOAC)
Challenge
Quantifying bleeding risk reduction versus stroke prevention benefit across diverse patient populations with varying renal function
ArcaScience Approach
Integrated 4 pivotal trials and post-marketing bleeding reports from 45,000+ patients with renal function-stratified analysis
Results
- ✓Renal-adjusted benefit-risk scoring
- ✓88% accuracy in major bleeding signal detection
- ✓Label update BRA prepared in 3 weeks vs. 12 weeks historically
SGLT2 Inhibitor
Challenge
Expanding cardiovascular BRA beyond diabetes indication while managing DKA and amputation safety signals
ArcaScience Approach
Cross-indication BRA integrating HFrEF trial data with diabetes CVOT safety signals and real-world evidence
Results
- ✓Quantified cardiovascular mortality benefit
- ✓DKA risk contextualized across indications
- ✓Supported supplemental NDA BRA section
PCSK9 Inhibitor
Challenge
Long-term safety monitoring for neurocognitive effects and diabetes onset in a preventive cardiovascular therapy
ArcaScience Approach
Deployed neurocognitive and metabolic signal detection models with 7-year longitudinal follow-up data
Results
- ✓Automated neurocognitive AE surveillance
- ✓96% specificity in new-onset diabetes signal detection
- ✓PSUR generation time reduced by 62%
Aggregate Outcomes
Results Across Cardiology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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