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Coding is part of grading, not a separate workflow. Every adverse event Burna grades carries its MedDRA v28.0 LLT code, with the source sentence attached and the CTCAE criterion alongside. The trial database gets what it needs. Pharmacovigilance gets what it needs. The coder no longer reads the same note twice.
MedDRA v28.0 LLT codes on every graded event. Aligned with CTCAE v6.0. Refreshed with each NCI CTCAE release. Citation-bound by design. Integrates with Argus, Veeva Vault Safety, and ArisGlobal at the case-output boundary. E2B(R3) encoding for ICSR. 21 CFR Part 11 e-signature trail.
Coding is part of grading, not a separate workflow.
Every CTCAE v6.0 criterion ships with its MedDRA v28.0 LLT code attached. Oncology-specific terminology is explicitly modeled, not post-hoc mapped.
The same grading pass produces the CTCAE grade for the trial database and the MedDRA LLT code for pharmacovigilance. No second human pass for coding.
Mid-size oncology trials spend this on MedDRA coding labor today. Portfolio sponsors spend low millions annually. Burna folds the work into existing grading economics.
MedDRA is the vocabulary regulators speak. CTCAE is the vocabulary clinicians speak. Both must travel with every graded adverse event in oncology drug development. Burna produces them together because they describe the same clinical fact and the cost of producing them separately, by separate teams, in separate workflows, is the line item every safety budget knows by heart.
See the CTCAE Grading page →The signature is captured on the encoded record, with the CTCAE grade and the MedDRA LLT code together, not on the raw output. One artifact serves both audiences.
Standalone MedDRA auto-coders read text after attribution and grading have already been done. Burna codes inside the same encounter that produces the grade. The structural difference is that the coding decision and the grading decision share the same evidence, the same citation, and the same audit trail.
| Capability | Burna | Standalone auto-coders | Offshore coding shops |
|---|---|---|---|
| Produced inside the same encounter as CTCAE grading | Yes | No, separate workflow | No, manual handoff |
| Source sentence attached to every coded term | Yes | Limited | Human-dependent |
| Oncology-specific terminology explicitly modeled | Yes (irAE, CRS, ICANS, neurotox) | Generic MedDRA | Generic MedDRA |
| CTCAE criterion travels with the MedDRA code | Yes | No | No |
| Integration with Argus, Veeva Vault Safety, ArisGlobal | Yes, at case-output boundary | Varies | Manual case entry |
| Refreshed with each NCI CTCAE release | Yes | Independent cadence | N/A |
| Coding economics folded into grading workflow | Yes | Separate spend | Separate spend |
Coding is not a separate product line. Pricing scales with seat count, trial volume, and postmarket surveillance scope, not with coding gating.
Every CTCAE v6.0 criterion ships with its canonical MedDRA v28.0 LLT code. Aligned with the NCI-published mapping. Refreshed with each NCI CTCAE release so the version drift problem stops being yours.
LLT, PT, HLT, HLGT, and SOC are all surfaced on the coded record. Pharmacovigilance signal detection, MedDRA SMQ navigation, and aggregate reporting all need the full hierarchy. Burna provides it on every encounter.
The source sentence that supported the CTCAE grade is the same source sentence the MedDRA coder would have read. Burna attaches it to the coded record. Downstream PV audit, monitor review, and regulator inquiry all read from one citation chain.
Immune-related adverse events (irAEs), cytokine release syndrome, ICANS, neurotoxicity variants, CRS grading, and the long tail of oncology-specific MedDRA terms are modeled explicitly. Not post-hoc mapped from generic coding logic.
Coded output flows into Argus, Veeva Vault Safety, and ArisGlobal at the case-output boundary. E2B(R3) encoding for ICSR submission. No replacement of your existing PV stack; Burna sits upstream and feeds it.
In multi-site trials, coding drift across sites is a quiet driver of poor signal detection. Burna codes in real time using the same hierarchy and the same source-citation discipline at every site, so cross-site coding consistency is a property of the architecture, not of the QC layer.
Burna codes inside your sponsor or CRO MedDRA license, on data you already have rights to process. Burna does not redistribute MedDRA terms and does not operate a public MedDRA browser. The licensing posture is deliberate and defensible.
The twelve-agent cascading constraint pipeline that grades CTCAE also produces the MedDRA LLT code. The terminal Regulatory Encoding agent attaches the code to the signed record. The clinician signature is captured on the encoded artifact, not on the raw output.
Read the full engine architecture →The structural integrity of citation-bound CTCAE grading is the same structural integrity that makes the MedDRA code defensible. Both vocabularies come from the same evidence chain.
The bilingual record serves different teams differently. Each gets what it needs from the same artifact.
Read MedDRA. Adjudicate cases. Sign narratives. The coded record is the case input, pre-coded, with citation. See /pharmacovigilance for the PV-team architecture conversation.
Read CTCAE. Run trials. Submit safety packages. The same coded record carries the CTCAE grade their database needs, with the MedDRA code their PV team needs already attached. See /pharma.
Read MedDRA at scale. Run signal detection daily. Submit ICSRs continuously. The Burna postmarket PV module (2027 launch) processes ICSR intake and coding at lifecycle scale. See /postmarket-pv.
The six we hear most often.
Read the full FAQ →No. Burna produces MedDRA codes inside the same grading pass that produces the CTCAE grade. Argus, Veeva Vault Safety, and ArisGlobal are downstream case management platforms; Burna feeds them coded records at the case-output boundary. The two are complementary in a sponsor PV stack.
Yes. Burna codes inside your sponsor or CRO MedDRA license, on data you already have rights to process. Burna does not redistribute MedDRA terms and does not operate as a MedDRA Browser Service Provider. The licensing posture is deliberate. Your MSSO subscription covers the use.
MedDRA v28.0 at launch, aligned with CTCAE v6.0. Refreshed with each NCI CTCAE release. The version drift between CTCAE and MedDRA is a maintenance burden that NCI absorbs; Burna inherits the NCI cadence so you do not have to manage it.
The same source sentence that supports the CTCAE grade supports the MedDRA LLT code. The encoded record carries both vocabularies, the source sentence, the CTCAE criterion, and the named attribution algorithm. Downstream PV audit, monitor review, and regulator inquiry read from one citation chain.
Not in the v1 product. Burna codes prospectively at the point of clinical encounter. Retrospective recoding is on the roadmap; ask in your scoping conversation for the current timeline.
No. Per the MSSO licensing posture, Burna does not publish a free standalone MedDRA browser. The CTCAE v6.0 lookup tool at /ctcae-lookup displays the NCI-published CTCAE-to-MedDRA mapping, which is publicly available.
For sponsor safety teams, PV operations leaders, and CRO partnerships looking to fold MedDRA coding into the same workflow that grades CTCAE, this is the architecture conversation to have.
The trial-side platform is in production now. Every graded adverse event ships with its MedDRA LLT code attached. SMART on FHIR inside Epic, Oracle Health, Athena, and the rest. Integration with Argus, Veeva Vault Safety, and ArisGlobal at the case-output boundary.
Scope, endpoints, and deployment timeline are defined before kickoff. Pre-negotiated MSA, Quality Agreement, and Data Processing Agreement.
ICSR intake automates from MAH portal, literature, social listening, and HCP reports. Burna first-passes everything: dedup, MedDRA coding, first-pass grading, narrative generation. Safety Medical Officers adjudicate every adjudication-worthy case. Pilot partners scoping now lock in 2026 economics.
For pilot scoping conversations, see /postmarket-pv or /pharmacovigilance.