The questions buyers actually ask, answered.
The cross-cutting questions buyers, partners, regulators, and families ask first. Architecture, pilot, pricing, validation, security, patient, investor, and how Burna compares to the systems already in your stack. Audience-specific FAQs live on the audience pages.
What Burna does.
Burna is the AI platform for accelerated clinical research, from first-in-human trials through postmarket surveillance. It produces CTCAE coding, including TERM and CATEGORY, coupled with intelligence to support determination of severity GRADE, with mandatory citation to source text and multi-drug attribution using WHO-UMC and Kramer algorithms across 42 oncology regimen profiles. A clinician reviews and signs every record.
A scribe writes the note. Burna reads it. There is an ambient recorder built in because it is convenient, and you can sync notes from your EHR instead. The product is the grading and the attribution.
Four buyers told us that, and all four asked for a pilot by the end of the demo. Most often it means there is a place in the EHR to enter a grade, or a rule that fires when a lab value crosses a threshold. Both are real. Burna adds the part that reads the prose, retrieves the criterion, and scores attribution per drug.
The cascading constraint pipeline.
Burna retrieves the governing CTCAE criterion, binds the grade to it, scores attribution with WHO-UMC and Kramer, and records who signed. So you get the same grade twice, you can see which criterion produced it, and you can show a monitor where it came from. That is the difference between an answer and evidence.
Every grade Burna returns is bound to the CTCAE criterion that produced it and to the span of text in the record that supports it. Your clinician can independently review that basis, which is what the term means and why it matters to a regulator.
It surfaces in your dashboard for your team to work. Real-time clinical alerting sits in a different regulatory category, and we have kept a deliberate line there.
The 90-day design partner pilot.
Epic and Oracle Health through SMART on FHIR, iKnowMed, and others on request. A new integration is usually about two weeks of our work. The longer part is your paperwork, and we say that up front.
We are running a concordance study with Mayo Clinic Platform_Accelerate and a pilot with a physician-owned community practice running fifty trials. Both, deliberately. What works at one and what changes at the other is the thing we most want to find out.
How Burna proves it.
December 2026, from the Mayo concordance study: 1,600 cases across three campuses, against an adjudicated two-clinician reference panel, with Andrea Pirzkall as co-principal investigator. We publish a number then, including in a sales meeting.
No. Every grade is a draft until your clinician signs it, and the criterion and the source line sit on screen so they can check the basis themselves. That independent review is what places Burna outside the device definition, as non-device clinical decision support. Our Q-submission with the FDA is in for the written confirmation.
HIPAA, 21 CFR Part 11, GDPR aligned.
HIPAA-aligned architecture, 21 CFR Part 11 signatures, GDPR alignment, and BAAs signed. PHI lives in an isolated plane, and every access to it is audited.
It stays yours. Your credentials stay in your systems, PHI lives in an isolated store, and Protocol Studio gives you an isolated model instance where your protocol needs to stay on infrastructure you hold.
Every question, answered.
The full library, grouped the way buyers ask. Each answer has its own page.
AI architecture
- How is Burna AI's grading engine built?
- Why does Burna AI use twelve agents instead of one model?
- What does it mean that Burna AI is citation-bound by design?
- Can a general-purpose LLM grade CTCAE adverse events the way Burna AI does?
- How many patents has Burna AI filed?
- What language models does Burna AI use?
- How does Burna AI prevent AI hallucinations in adverse event grading?
Analytics and reliability
Audit trail and e signature
Comparison and alternatives
- How is Burna AI different from EDC systems like Medidata Rave and Veeva Vault?
- How is Burna AI different from AI medical scribes like Abridge?
- How is Burna AI different from Flatiron Health?
- How is Burna AI different from general-purpose clinical AI tools?
- How is Burna AI different from asking a single LLM to grade adverse events?
- Could Veeva or Medidata add AI adverse event grading as a feature?
Contact
CTCAE grading
- What is CTCAE grading?
- How does Burna AI grade CTCAE adverse events?
- How long does Burna AI take to grade an adverse event?
- Which CTCAE versions does Burna AI support?
- Which MedDRA version does CTCAE v6.0 use?
- What input modes does Burna AI support?
- How many adverse events can Burna AI grade from one clinical note?
- How does Burna AI handle adverse event terminology that varies across institutions?
- How does Burna AI tell a treatment-related adverse event from a pre-existing condition?
- How does Burna AI detect copy-forward in clinical notes?
Data and privacy
EDC integration
EHR integration
- Which EHR systems does Burna AI integrate with?
- What is SMART on FHIR?
- Does Burna AI need a long IT integration project?
- How does Burna AI import patient records from the EHR?
- How does Burna AI import clinical notes from the EHR for grading?
- How many FHIR resource types does Burna AI use from Oracle Health (Cerner)?
Engagement
For cancer centers
For CROs and phase 1 sites
For pharma sponsors
Founder and team
Healthnotes and RTM
Multi drug attribution
- What is multi-drug attribution?
- How does Burna AI compute adverse event attribution?
- What are the WHO-UMC causality categories and the Kramer algorithm?
- What is dechallenge and rechallenge?
- Which oncology regimens does Burna AI cover?
- Can Burna AI grade single-agent trials too?
- How does Burna AI handle protocols where the trial drug profile is sensitive sponsor IP?
Multi rater quality
Partnerships and validation
Platform
Pricing and pilots
PRO-CTCAE and patient reporting
- What is PRO-CTCAE?
- How does Burna AI capture patient-reported symptoms in a clinical trial?
- What languages does Healthnotes, the patient self-reporting app, support?
- What is RTM (remote therapeutic monitoring) billing?
- What is the published evidence for patient symptom self-reporting in oncology?
- What happens when a trial participant reports a severe symptom in Healthnotes?
Product overview
Protocol and knowledge base
Regulatory reporting
- Does Burna AI generate regulatory reports such as FDA MedWatch, IRB and SAE reports?
- Does Burna AI code adverse events to MedDRA?
- What is a SUSAR in clinical trials, and when must it be reported?
- What is an ICSR (individual case safety report) in pharmacovigilance?
- What is E2B(R3), and does Burna AI support E2B(R3) submissions?
- Which safety reports does pharmacovigilance require, from ICSRs to DSURs and PBRERs?
- How does Burna AI handle 21 CFR Part 11 electronic records and signatures?
Roadmap
Security
Security and compliance
Shipped features
- What major features did Burna AI ship in 2025 and 2026?
- What grading and workflow features did Burna AI ship in 2025 and 2026?
- What integration and protocol features did Burna AI ship in 2025 and 2026?
- What patient, reporting, and analytics features did Burna AI ship in 2025 and 2026?
- What compliance, mobile, and public surfaces did Burna AI ship in 2025 and 2026?
- What is the Burna AI changelog?
- How often does Burna AI ship updates?