Burna AI offers an AI‑driven platform that automatically extracts adverse events from oncology clinical notes and assigns CTCAE v6.0 grades with roughly 96 % accuracy. It integrates securely with major EHRs via FHIR APIs, provides source citations and a complete audit trail for each grade, and includes a clinician‑in‑the‑loop review step to ensure final approval.
Funding
Funding not disclosed
Founders
Product
Problem
Oncologists and clinical trial staff must manually review patient notes to assign CTCAE adverse event grades, a process that is labor‑intensive, prone to inter‑rater variability, and difficult to audit for regulatory compliance. Delays in grading can postpone safety assessments and increase the risk of missed critical signals.
Solution
Burna AI delivers an AI‑driven platform that automatically extracts adverse events from clinical documentation and assigns CTCAE v6.0 grades with reported 96 % accuracy. Each suggested grade is accompanied by a citation to the source note and the relevant CTCAE criteria, creating a complete, auditable trail. The system integrates directly with major EHRs (Epic, Cerner, Veeva) via secure, HIPAA‑ and SOC 2‑compliant connections, eliminating data migration and preserving workflow continuity. A human‑in‑the‑loop review step ensures that clinicians retain final approval while benefiting from instant, evidence‑based recommendations. The platform also maps grades across CTCAE versions, supporting ongoing trials that span multiple guideline releases.
Target Audience
Primary users are oncology clinical operations teams, pharmacovigilance departments, and clinical trial sponsors who need rapid, accurate CTCAE grading across hospitals and research sites.
Features
- Natural‑language processing engine that identifies adverse events in real time as clinical notes are entered.
- AI grading model calibrated to CTCAE v6.0, delivering 96 % concordance with expert adjudication.
- Automatic generation of evidence citations and a full audit trail for each grade, facilitating regulatory reporting.
- Dual‑layer verification workflow (AI suggestion + clinician approval) to maintain safety and accountability.
- Seamless, secure integration with Epic, Cerner, and Veeva via FHIR‑compatible APIs; no data export or duplicate entry required.
- Built‑in support for CTCAE version mapping, enabling concurrent use of multiple guideline editions.
- Enterprise‑grade security features including HIPAA compliance, SOC 2 certification, and 21 CFR Part 11 readiness.
- Unified user interface that presents coordinators, oncologists, pharmacists, and patients with role‑specific views and actionable alerts.