Adverse event grading in oncology is still manual, inconsistent, and time-consuming, in clinical trials and in postmarket surveillance. Burna AI is building the platform that makes safety data accurate, consistent, and submission-ready across the entire drug lifecycle.

Our first product, CTCAE AI, automates adverse event grading with:

- CTCAE grading (v5.0 and v6.0) with citation to source text and criteria
- Multi-drug causality attribution using WHO-UMC and Kramer algorithms with probability scoring per drug
- 42 pre-built oncology regimen profiles for combination therapy
- Batch clinical note processing: one note in, all AEs graded
- Comorbidity-aware grading: distinguishes drug toxicities from pre-existing conditions
- Patient self-reporting module enabling continuous CTCAE grading between visits
- Automated safety reporting: IND safety reports, CIOMS forms, MedWatch, DSURs
- Postmarket pharmacovigilance: MedDRA coding, E2B(R3) formatting for electronic regulatory submission
- Zero hallucination architecture: outputs constrained to valid CTCAE grades with mandatory citations
- Human-in-the-loop always: AI suggests, clinicians decide

Built for regulated environments from day one. HIPAA compliant. SOC 2 certified. 21 CFR Part 11 aligned. Real-time architecture built from the ground up. EHR/EDC integration via SMART on FHIR for Epic, Oracle Health, Medidata, and Veeva Vault EDC.

Partnering with leading academic cancer centers on clinical validation. Our advisory network spans oncologists at NCI-designated cancer centers, pharma clinical development leaders, clinical informaticists, and federal health IT executives.

Member of CancerX under the HHS Cancer Moonshot Initiative. Two patents filed.

Burna AI

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