Prediction

Predictive Benefit-Risk Assessment for Early Phase Decision-Making

Evaluate more molecules. Make faster, better-informed development decisions.

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

Comprehensive BRA delivered in 3–4 weeks : 11, 700 evidence sources analyzed across clinical trials, publications, and regulatory data, with full traceability.

6-step BRAT 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 recommendations.

Capacity multiplied from 2 molecules/year to 12+ per team without headcount increase.

The impact

Sanofi's Global Translational Medicine team benchmarked ArcaScience's platform directly against a previously completed expert-led study. The AI assessment captured 100% of known risks while identifying additional key potential risks, reviewed and validated by the original study author and cross-functional BRA and AI expert teams.

80% reduction in time and cost per analysis.

“As BRA experts, we're naturally skeptical of automated approaches. But when we benchmarked the AI platform against our own completed study, the quality was undeniable. The outputs are rigorous, fully sourced, and actionable.”

Senior BRA Expert
Sanofi Global Translational Medicine

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