Target
- Global Translational Medicine
- Clinical Development
- R&D
The problem
At 6 months per molecule, traditional assessment limits R&D teams to 2–3 decisions per year, leaving valuable candidates deprioritized and late-stage risks unpredicted.
The solution: the 1st structured Benefit-Risk regulatory-qualified framework
Comprehensive BRA delivered in 3–4 weeks : 11, 700 evidence sources analyzed across clinical trials, publications, and regulatory data, with full traceability.
6-step Strucutres Benefit-Risk Evaluation methodology : from study configuration and disease analysis to head-to-head product profiling against authorized comparators.
AI-powered extraction and harmonization of benefit and risk data points across pre-clinical and clinical evidence, validated against FDA & EMA recommendations.
Capacity multiplied from 2 molecules/year to 12+ per team without headcount increase.
The impact
Our clients' Global Translational Medicine teams benchmarked ArcaScience's platform directly against previously completed expert-led Benefit-Risk Assessments.
Our AI assessment systematically captured 100% of known risks while identifying additional key potential risks,
applying 80% reduction in time and cost per analysis.
Reviewed and validated by original study owners, cross-functional BRA and AI expert teams.
“As Benefit-risk Assessment experts, we're naturally skeptical of automated approaches. But when we benchmarked the BRA platform against our own completed study, the quality was undeniable. The outputs are rigorous, fully sourced, actionable & appreciated by regulators.”