Burna AI is the AI platform for accelerated clinical research, from first-in-human trials through postmarket surveillance. Burna AI performs automated adverse event grading and attribution in real time, providing clear rationale and audit-ready evidence, including generation of IRB, sponsor and FDA reports. Burna AI delivers CTCAE v5 and v6 grades and MedDRA LLT codes on every encounter; enabling standardization, cross-site consistency and accuracy of clinical research data. AI suggests, clinicians decide. Human-in-the-loop, always. The grading engine is twelve specialized agents in a cascading constraint pipeline, with two patents filed. Attribution scores every drug in a regimen with the WHO-UMC and Kramer methods, and every grade traces to the line in the medical record that produced it. The platform is built for HIPAA and 21 CFR Part 11. Our SOC 2 Type 2 audit is in progress. Burna AI is a Mayo Clinic Platform_Accelerate participant.
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