ArcaScience Information

ArcaScience is setting the new standard for Benefit–Risk Assessment, leveraging AI to turn clinical uncertainty into up to +5% approval success. Our AI-Benefit-Risk Solution is the first to be fully aligned with CIOMS and ICH guidelines, featuring: > Regulatory-ready: BRA exports are compliant with CIOMS/FDA/EMA, ready for submission to regulatory agencies > Full expert control: every AI-generated item can be reviewed, edited, and validated by the expert > Cross-functional collaboration: pharmacovigilance, clinical, regulatory, and medical affairs teams work on a single shared platform across the entire drug lifecycle > AI-powered synthesis: automated identification, extraction, and structuring of clinical and safety data > 100% sourced, no hallucination: full traceability on every data point The Impact: We reduce BRA timelines from 3–8 months to just 2–3 days, deliver +5% market access, and provide best-in-class candidate optimization both during and after clinical trials.