Target
- Regulatory Affairs
- Clinical Development
The problem
Regulatory agencies require fully auditable BRAs, yet traditional expert-led methods cannot deliver submission-ready dossiers at the speed & scale regulatory timelines demand.
The solution: the 1st structured Benefit-Risk regulatory-qualified framework
End-to-end Benefit-Risk Assessment filled in under one day & completed in under 1 month: systematic identification, extraction, and synthesis of evidence across clinical studies, meta-analyses, and systematic reviews.
Full transparency: quality control metrics documenting model performance provided alongside all findings, with 100% data traceability.
6-step sBRA methodology (BRAT, UMBRA, FDA) executed on ArcaScience's platform, fully compliant with FDA AI for Regulatory Decision-Making guidance and FDA medical device benefit-risk framework.
Regulatory team bandwidth redirected from manual evidence compilation to strategic communication with regulators and trial data analysis.
The impact
Dilon Technology secured FDA submission within the required timeline for a hemostatic device indication expansion, a comprehensive BRA covering 6,500+ screened articles and 15,000+ extracted evidence points, with no quality concerns or additional information requests received to date.
80% cost reduction compared to traditional methods.
“The ArcaScience BRA platform furnished a clear, exhaustive, and fully-sourced analysis, achieving 100% data traceability and eliminating the risk of factual hallucination under an unprecedented turnaround time.”