Frequently Asked Questions

Is Burna AI HIPAA compliant?

Yes. Security and compliance are foundational, not afterthoughts. Burna AI is HIPAA compliant, SOC 2 certified, and built to meet 21 CFR Part 11 requirements. Patient data is encrypted at rest and in transit, with complete audit trails for every action.

How does it integrate with our EHR?

We connect through standard protocols like SMART on FHIR and HL7—the same standards your EHR already supports. Integration is read-only by default, meaning we pull the context we need without moving or duplicating sensitive data. Most teams are connected within days, not months.

How long does implementation take?

Most teams are up and running in under a week. There's no lengthy training or certification required. Your team can start seeing value on day one, with our support alongside you as you scale.

Does a human still review everything?

Always. Burna AI surfaces intelligence, evidence, and recommendations—but every decision stays with your clinical team. We call it human-in-the-loop by design. The AI handles the heavy lifting; you stay in control.

What clinical workflows does it support?

We're built specifically for oncology operations—the complex, high-stakes work that other tools weren't designed for. If you're curious whether your workflow fits, we'd love to show you. Book a demo and we'll walk through it together.

What is Burna AI?

Burna AI is a clinical intelligence platform that automates CTCAE v6.0 adverse event grading for oncology teams. It reads clinical notes, labs, and patient data, then delivers accurate AE grades with full citations and evidence trails in seconds. Burna AI is designed for research coordinators, clinical trial teams, and oncology practices who need faster, more consistent adverse event assessments without sacrificing accuracy.

How does Burna AI automate CTCAE grading?

Burna AI is a clinical intelligence platform that automates CTCAE v6.0 adverse event grading for oncology teams. It reads clinical notes, labs, and patient data, then delivers accurate AE grades with full citations and evidence trails in seconds. Burna AI is designed for research coordinators, clinical trial teams, and oncology practices who need faster, more consistent adverse event assessments without sacrificing accuracy.

What is CTCAE v6.0 and why does it matter?

CTCAE (Common Terminology Criteria for Adverse Events) version 6.0 is the latest standardized framework developed by the National Cancer Institute for grading the severity of adverse events in oncology patients. Accurate CTCAE grading is critical for patient safety, regulatory compliance, and clinical trial integrity. Burna AI is built specifically for CTCAE v6.0 to ensure oncology teams are working with the current standard.

Who uses Burna AI?

Burna AI is built for oncology research coordinators, clinical trial teams, cancer centers, pharmaceutical sponsors, and community oncology practices. Anyone responsible for grading adverse events in cancer care or clinical trials can benefit from Burna AI's speed, accuracy, and audit-ready documentation.

How accurate is Burna AI for adverse event grading?

Burna AI delivers 95%+ accuracy on CTCAE v6.0 adverse event grading, validated against board-certified oncologist assessments. Every grade includes citations to source documentation, so clinicians can verify the evidence before finalizing. Burna AI is designed for zero tolerance on hallucinations, meaning it only grades when it has sufficient evidence.

Is Burna AI HIPAA compliant?

Yes. Burna AI is fully HIPAA compliant, SOC 2 certified, and built to meet 21 CFR Part 11 requirements for electronic records in clinical trials. Patient data is encrypted at rest and in transit, with complete audit trails for every action. Security and compliance are foundational to how Burna AI is built, not afterthoughts.

How does Burna AI integrate with EHR systems?

Burna AI integrates with major EHR platforms including Epic and Oracle Health using standard protocols like SMART on FHIR and HL7. Integration is read-only by default, meaning Burna AI pulls the clinical context it needs without moving or duplicating sensitive patient data. Most teams are fully connected within days, not months.

How long does it take to implement Burna AI?

Most oncology teams are up and running with Burna AI in under a week. There's no lengthy training or certification required. Your team can start seeing value on day one, with guided onboarding and support as you scale across workflows and sites.

Does Burna AI replace human review of adverse events?

No. Burna AI is designed with a human-in-the-loop architecture. The AI handles the time-consuming work of extracting data, matching CTCAE criteria, and generating suggested grades. But every final decision stays with your clinical team. Burna AI surfaces intelligence and evidence; clinicians make the call.

What makes Burna AI different from other clinical AI tools?

Burna AI is purpose-built for oncology and specifically for CTCAE adverse event grading. Unlike generic AI tools retrofitted for healthcare, Burna AI understands the nuances of cancer care, including complex treatment regimens, overlapping toxicities, and the specific language of oncology documentation. It also delivers evidence-grounded grades with citations, not black-box predictions.

Can Burna AI help with clinical trial adverse event reporting?

Yes. Burna AI streamlines adverse event grading for clinical trials by automating CTCAE v6.0 assessments and generating audit-ready documentation. This helps research coordinators reduce manual review time, improve grading consistency across sites, and maintain compliance with FDA and sponsor requirements.

How does Burna AI handle complex or ambiguous adverse events?

When adverse event data is ambiguous or incomplete, Burna AI flags the case for clinician review rather than forcing a grade. It surfaces all available evidence and highlights areas of uncertainty, so your team can apply clinical judgment where it matters most. Burna AI is designed to support decision-making, not replace it.

What types of adverse events can Burna AI grade?

Burna AI can grade any adverse event covered by the CTCAE v6.0 framework, including hematologic toxicities, gastrointestinal events, neurological symptoms, dermatologic reactions, and more. The platform is trained on the full CTCAE criteria set and continuously updated to reflect the latest clinical standards.

How does Burna AI improve adverse event grading consistency?

Manual CTCAE grading often results in 60% or more variability between reviewers. Burna AI standardizes the grading process by applying consistent criteria across every patient and every note. This reduces inter-rater variability, improves data quality for trials, and ensures auditable, reproducible assessments.

How can I see Burna AI in action?

You can schedule a demo at burna.ai to see how Burna AI handles CTCAE v6.0 grading for your specific workflows. The demo takes about 15 minutes and includes a walkthrough of EHR integration, adverse event extraction, grading accuracy, and audit trail documentation. No commitment required.

Is Burna AI HIPAA compliant?

Yes. Security and compliance are foundational, not afterthoughts. Burna AI is HIPAA compliant, SOC 2 certified, and built to meet 21 CFR Part 11 requirements. Patient data is encrypted at rest and in transit, with complete audit trails for every action.

How does it integrate with our EHR?

We connect through standard protocols like SMART on FHIR and HL7—the same standards your EHR already supports. Integration is read-only by default, meaning we pull the context we need without moving or duplicating sensitive data. Most teams are connected within days, not months.

How long does implementation take?

Most teams are up and running in under a week. There's no lengthy training or certification required. Your team can start seeing value on day one, with our support alongside you as you scale.

Does a human still review everything?

Always. Burna AI surfaces intelligence, evidence, and recommendations—but every decision stays with your clinical team. We call it human-in-the-loop by design. The AI handles the heavy lifting; you stay in control.

What clinical workflows does it support?

We're built specifically for oncology operations—the complex, high-stakes work that other tools weren't designed for. If you're curious whether your workflow fits, we'd love to show you. Book a demo and we'll walk through it together.

What is Burna AI?

Burna AI is a clinical intelligence platform that automates CTCAE v6.0 adverse event grading for oncology teams. It reads clinical notes, labs, and patient data, then delivers accurate AE grades with full citations and evidence trails in seconds. Burna AI is designed for research coordinators, clinical trial teams, and oncology practices who need faster, more consistent adverse event assessments without sacrificing accuracy.

How does Burna AI automate CTCAE grading?

Burna AI is a clinical intelligence platform that automates CTCAE v6.0 adverse event grading for oncology teams. It reads clinical notes, labs, and patient data, then delivers accurate AE grades with full citations and evidence trails in seconds. Burna AI is designed for research coordinators, clinical trial teams, and oncology practices who need faster, more consistent adverse event assessments without sacrificing accuracy.

What is CTCAE v6.0 and why does it matter?

CTCAE (Common Terminology Criteria for Adverse Events) version 6.0 is the latest standardized framework developed by the National Cancer Institute for grading the severity of adverse events in oncology patients. Accurate CTCAE grading is critical for patient safety, regulatory compliance, and clinical trial integrity. Burna AI is built specifically for CTCAE v6.0 to ensure oncology teams are working with the current standard.

Who uses Burna AI?

Burna AI is built for oncology research coordinators, clinical trial teams, cancer centers, pharmaceutical sponsors, and community oncology practices. Anyone responsible for grading adverse events in cancer care or clinical trials can benefit from Burna AI's speed, accuracy, and audit-ready documentation.

How accurate is Burna AI for adverse event grading?

Burna AI delivers 95%+ accuracy on CTCAE v6.0 adverse event grading, validated against board-certified oncologist assessments. Every grade includes citations to source documentation, so clinicians can verify the evidence before finalizing. Burna AI is designed for zero tolerance on hallucinations, meaning it only grades when it has sufficient evidence.

Is Burna AI HIPAA compliant?

Yes. Burna AI is fully HIPAA compliant, SOC 2 certified, and built to meet 21 CFR Part 11 requirements for electronic records in clinical trials. Patient data is encrypted at rest and in transit, with complete audit trails for every action. Security and compliance are foundational to how Burna AI is built, not afterthoughts.

How does Burna AI integrate with EHR systems?

Burna AI integrates with major EHR platforms including Epic and Oracle Health using standard protocols like SMART on FHIR and HL7. Integration is read-only by default, meaning Burna AI pulls the clinical context it needs without moving or duplicating sensitive patient data. Most teams are fully connected within days, not months.

How long does it take to implement Burna AI?

Most oncology teams are up and running with Burna AI in under a week. There's no lengthy training or certification required. Your team can start seeing value on day one, with guided onboarding and support as you scale across workflows and sites.

Does Burna AI replace human review of adverse events?

No. Burna AI is designed with a human-in-the-loop architecture. The AI handles the time-consuming work of extracting data, matching CTCAE criteria, and generating suggested grades. But every final decision stays with your clinical team. Burna AI surfaces intelligence and evidence; clinicians make the call.

What makes Burna AI different from other clinical AI tools?

Burna AI is purpose-built for oncology and specifically for CTCAE adverse event grading. Unlike generic AI tools retrofitted for healthcare, Burna AI understands the nuances of cancer care, including complex treatment regimens, overlapping toxicities, and the specific language of oncology documentation. It also delivers evidence-grounded grades with citations, not black-box predictions.

Can Burna AI help with clinical trial adverse event reporting?

Yes. Burna AI streamlines adverse event grading for clinical trials by automating CTCAE v6.0 assessments and generating audit-ready documentation. This helps research coordinators reduce manual review time, improve grading consistency across sites, and maintain compliance with FDA and sponsor requirements.

How does Burna AI handle complex or ambiguous adverse events?

When adverse event data is ambiguous or incomplete, Burna AI flags the case for clinician review rather than forcing a grade. It surfaces all available evidence and highlights areas of uncertainty, so your team can apply clinical judgment where it matters most. Burna AI is designed to support decision-making, not replace it.

What types of adverse events can Burna AI grade?

Burna AI can grade any adverse event covered by the CTCAE v6.0 framework, including hematologic toxicities, gastrointestinal events, neurological symptoms, dermatologic reactions, and more. The platform is trained on the full CTCAE criteria set and continuously updated to reflect the latest clinical standards.

How does Burna AI improve adverse event grading consistency?

Manual CTCAE grading often results in 60% or more variability between reviewers. Burna AI standardizes the grading process by applying consistent criteria across every patient and every note. This reduces inter-rater variability, improves data quality for trials, and ensures auditable, reproducible assessments.

How can I see Burna AI in action?

You can schedule a demo at burna.ai to see how Burna AI handles CTCAE v6.0 grading for your specific workflows. The demo takes about 15 minutes and includes a walkthrough of EHR integration, adverse event extraction, grading accuracy, and audit trail documentation. No commitment required.