Target
- Regulatory Affairs
- Clinical Development
The problem
Regulatory agencies require fully auditable BRAs for every label decision, yet traditional expert-led methods can't deliver them at the speed or scale regulatory timelines demand.
The solution
End-to-end BRA completed in under one 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 BRAT methodology 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 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.”