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The twelve-agent cascading constraint pipeline that grades adverse events at the point of clinical encounter extends to the postmarket ICSR. Triage, attribution, MedDRA coding, and AE narrative generation with the evidence attached. The same engine, from IND through twenty years of postmarket surveillance.
Twelve specialized agents in a patented cascading constraint pipeline. Two patents filed. MedDRA v28.0 coverage at launch, aligned with CTCAE v6.0. Citation-bound by design. Integrates with Argus, Veeva Vault Safety, and ArisGlobal at the case-output boundary. 21 CFR Part 11 e-signature trail. GVP Module VI aligned. Eligible for the CDER Emerging Drug Safety Technology Program.
One engine. One citation discipline. One audit trail.
Blockbuster oncology assets can generate up to a million ICSRs annually at a top-10 pharma sponsor. The same citation discipline that ran in the trial runs on every ICSR.
The 21 CFR 314.80 postmarket safety reporting obligation runs for the life of the approval. Lifecycle continuity is the architectural moat, not a roadmap.
Of deaths in oncology, attributable to poor adverse event management. The patient-impact reason postmarket signal detection is a clinical outcome, not a paperwork outcome.
Burna's postmarket pharmacovigilance platform extends the same twelve-agent cascading constraint pipeline that grades adverse events in clinical trials to the postmarket setting. ICSR triage, signal detection support, MedDRA coding, and AE narrative generation with named-algorithm attribution attached.
The same engine that read the protocol, the source note, and the lab during the trial reads the case report after approval. The same citation discipline applies. Argus, Veeva Vault Safety, and ArisGlobal manage cases after triage and attribution decisions are already made. Burna lives upstream of that decision, the same place it lived in the trial.
The same engine that graded the Phase 1 first-in-human SAE grades the postmarket ICSR twenty years later. The citation discipline does not change. The named-algorithm attribution does not change. The audit trail is one continuous chain from IND through the life of the approval.
The Safety Medical Officer opens a pre-processed case and adjudicates. Her reasoning logs back into the system. The calibration improves quietly behind her work. The adjudicated case flows to Argus, Veeva Vault Safety, or ArisGlobal as the system of record.
Arrive
Burna reads the source case data: the reporter narrative, the MedDRA-relevant terms, the patient history, the suspect drug, the concomitant medications, the temporal sequence.
Triage
The case is triaged automatically by seriousness, expectedness, and attribution likelihood. MedDRA coding is applied with citation back to the source narrative. Duplicate detection runs on intake.
Narrate
A first-pass AE narrative is generated with the WHO-UMC or Kramer attribution path attached. The narrative format aligns with sponsor standard operating procedure and downstream submission requirements.
Adjudicate
The Safety Medical Officer opens a pre-processed case and adjudicates. Her reasoning logs back into the system. The calibration improves quietly behind her work. The adjudicated case flows to Argus, Veeva Vault Safety, or ArisGlobal at the case-output boundary.
AI suggests. Safety Medical Officers decide. Human-in-the-loop, always.
MAH portal · literature · social listening · HCP report
Coded with citation back to the reporter narrative
WHO-UMC or Kramer attribution path attached
Safety Medical Officer adjudicates a pre-processed case
The postmarket platform is built on the same architecture as Burna's trial-side CTCAE grading engine. The capability list below describes what is operational for the 2027 design partner cohort.
Incoming cases are automatically categorized by seriousness, expectedness, and attribution likelihood. Duplicate detection runs on intake. The triage output is a ranked queue of adjudication-worthy cases, not an undifferentiated inbox. Built for blockbuster-class ICSR volumes where a single asset can generate over a million cases per year.
Full MedDRA v28.0 coverage at launch, aligned with CTCAE v6.0. Refreshed with each NCI CTCAE release. Oncology-specific terminology is explicitly modeled (immune-related adverse events, cytokine release syndrome, neurotoxicity variants, CRS grading, ICANS grading), not post-hoc mapped. Every coded term carries the source sentence and the MedDRA hierarchy path. See /meddra-coding for the full coding capability.
WHO-UMC and Kramer attribution paths applied to every case. 42 oncology regimen profiles encode the known adverse event spectrum, timing, and dose-response relationships of the component drugs. Multi-drug attribution returns a ranked causality with named-algorithm justification.
First-pass AE narratives drafted with the citation chain and attribution reasoning attached. The Safety Medical Officer reviews and adjudicates a pre-processed case rather than building one from scratch. The narrative format aligns with sponsor SOP and downstream submission requirements.
Aggregate ICSR surface updates daily. Disproportionality signals, regimen-level safety signals, and emerging adverse event patterns surface for the postmarket signal detection team with the underlying cases one click away. Built to feed sponsor PSUR, PBRER, and PADER evidence packages from live data, not from a periodic dump.
Burna sits upstream of the system of record. Adjudicated cases flow into Argus, Veeva Vault Safety, or ArisGlobal at the case-output boundary. Integration is at the structured-data level: the citation chain, the MedDRA coding, the attribution path, and the e-signature trail flow through. The sponsor's existing PV stack does not change. The decision-quality upstream of it does.
The Protocol Safe pattern from clinical trials extends to postmarket. Sponsor-tenant deployment inside the sponsor's AWS, Azure, or GCP environment available for sponsors who require it. Standalone hosted tenant available for sponsors without an internal cloud preference. Regional residency options match the trial-side platform.
The same engine. From IND through twenty years of postmarket.
From the postmarket pharmacovigilance technical briefBurna AI, May 2026 revision
Sponsor-tenant Protocol Safe inside your CTMS environment.
Every AE in the SAE database carries its Burna citation chain.
ICSR intake automates; SMOs adjudicate pre-processed cases.
Audit trail complete by definition. Same citation discipline throughout.
The structural moat is not a feature on the page. It is where Burna sits in the regulatory lifecycle of an oncology asset. Argus, Veeva Vault Safety, and ArisGlobal manage cases. They are the system of record for what happened after the attribution call was made. They were not built to unify the trial-side adverse event decision with the postmarket ICSR decision, and they do not.
Burna was. The twelve-agent cascading constraint pipeline that grades the Phase 1 SAE is the same pipeline that grades the postmarket case ten years after approval. The 42 oncology regimen profiles update with the asset. The WHO-UMC and Kramer attribution logic does not fork between trial and postmarket. The citation chain is one continuous audit trail.
For a sponsor reviewing a blockbuster oncology asset across its full regulatory life, that continuity is what lets the postmarket signal detection team trace a 2034 ICSR back to the Phase 2 SAE it most closely resembles. It is what lets the medical writer for the year-twelve PSUR pull from the same evidence structure the original CSR was built on. It is what lets the FDA reviewer reading the year-eighteen PADER see the same named-algorithm reasoning the IND submission carried.
One engine. One citation discipline. One audit trail. From IND through twenty years of postmarket surveillance.
The postmarket platform extends architecture that is already shipping for clinical trials. The cohort is open now for sponsors who want to scope the postmarket engagement before launch. Burna's twelve-agent pipeline is in production today on the clinical trial side. The postmarket platform extends the same architecture with MedDRA coding and ICSR triage as additions.
Sponsor VP Pharmacovigilance, Head of Safety Operations, and Head of PV Operations meet with Burna's clinical and engineering team. The asset (or portfolio of assets) is selected. ICSR volume is characterized. The current sponsor PV stack (Argus, Veeva Vault Safety, ArisGlobal) is mapped. The integration boundary is defined. The MSA, QA, and DPA are executed.
Workflow co-design with the sponsor's postmarket signal detection team and ICSR triage leads. MedDRA coding alignment against the sponsor's current adjudication practice. Regimen profile review for the asset's specific safety profile. Validation methodology agreed.
Production deployment against the agreed cohort assets. Validation evidence accumulates against the sponsor's ICSR adjudication baseline. The design partner cohort locks in launch economics before publication-driven price tier shifts.
The 2027 design partner cohort is sized for sponsors with at least one blockbuster oncology asset under active postmarket surveillance, or a portfolio of three or more oncology assets across Phase 3 and commercial. Sponsors with active clinical-trial deployments on Burna's trial-side platform have first conversation right.
The postmarket technical brief covers architecture, MedDRA coverage, integration patterns, cohort timeline, and validation methodology.
Download the technical brief →Standalone hosted tenant or sponsor-tenant deployment inside your AWS, Azure, or GCP environment. The engine is a twelve-agent cascading constraint pipeline; every coded term and every attribution requires a source sentence and an applied criterion. Architectural constraint, not runtime filter. Two patents filed. Full MedDRA v28.0 at launch, aligned with CTCAE v6.0. Integration with Argus, Veeva Vault Safety, and ArisGlobal at the case-output boundary.
Regional cloud deployments at launch: US (AWS, Azure), EU (Frankfurt, Dublin, Paris GDPR-resident), UK (London), Canada (Toronto), Australia (Sydney), Japan (Tokyo), Korea (Seoul), Singapore, UAE (Dubai), KSA (Riyadh). Data does not cross jurisdictions without explicit configuration. The platform only sees de-identified case content for the grading pass; identifiers remain inside the sponsor's case management boundary.
MSA, QA, DPA, subprocessor list, insurance certificates, right-to-audit clause, source code escrow option, and 90-day exit provisions are pre-negotiated single-document downloads. 21 CFR Part 11 validation package ships with every engagement. GVP Module VI alignment documented. EDSTP eligible. SOC 2 Type II audit kicked off Q2 2026.
At blockbuster postmarket scale, the business case is a spreadsheet. The platform is the conversation, not the tool. Design partner cohort terms are scoped per asset and per sponsor in the thirty-minute conversation.
Lifecycle-bundle economics for sponsors deploying both trial-side and postmarket on Burna.
The nine questions we hear most often from sponsor PV leadership.
Those systems manage cases, workflows, reporting, and submissions after triage and attribution have been decided. Burna operates upstream of that decision. Adjudicated cases flow into Argus, Veeva Vault Safety, or ArisGlobal at the case-output boundary as the system of record. The two are complementary in a sponsor PV stack; Burna is not a replacement for case management.
MAH portal, literature surveillance, social listening, HCP reports, and direct E2B(R3) ingestion. The platform deduplicates across sources on intake. Custom intake adapters are available for sponsor-specific channels.
The engine is the same: Twelve specialized agents in a patented cascading constraint pipeline, citation-bound by design. The trial-side platform applies CTCAE TERM, CATEGORY, and GRADE assignment to source notes inside the EHR. The postmarket platform applies MedDRA coding, ICSR triage, narrative generation, and signal detection support to the postmarket case. WHO-UMC and Kramer attribution logic, the 42 oncology regimen profiles, and the citation discipline are shared across both.
Full MedDRA v28.0 at launch, aligned with CTCAE v6.0. Refreshed with each NCI CTCAE release. Oncology-specific coding (immune-related adverse events, cytokine release syndrome, neurotoxicity variants, CRS grading, ICANS grading) is explicitly modeled, not post-hoc mapped.
No. The platform accelerates them. SMOs adjudicate every adjudication-worthy case. Burna handles intake, deduplication, MedDRA coding, first-pass attribution, and narrative draft. The Safety Medical Officer opens a pre-processed case in five to seven minutes instead of building one from scratch in twenty-five. The ratio changes. The judgment stays human. AI suggests; clinicians decide. Human-in-the-loop, always.
Validation package ships with every engagement. 21 CFR Part 11 compliance attested; audit-ready. GVP Module VI alignment documented. Burna AI is eligible for the CDER Emerging Drug Safety Technology Program (EDSTP). Pre-submission validation assistance available for EDSTP participants and EMA submissions.
The 2027 design partner cohort is the engagement window. Phase 1 scoping runs through 2026. Phase 2 co-design runs through Q2 2027. Phase 3 production launch begins Q3 2027 against the cohort sponsors' selected assets. Sponsors who want to shape the platform during the design partner window scope in 2026.
Regional cloud deployments available: US (AWS, Azure), EU (Frankfurt, Dublin, Paris GDPR-resident), UK (London), Canada (Toronto), Australia (Sydney), Japan (Tokyo), Korea (Seoul), Singapore, UAE (Dubai), KSA (Riyadh). Data does not cross jurisdictions without explicit configuration. Sovereign cloud partnerships in negotiation for Oracle Australia, G42 UAE, and STC Saudi Arabia.
No. Burna is a clinical decision support tool. SMOs and adjudicators approve every output. The platform does not prescribe, modify dose, or alter care pathways. 21 CFR Part 11, SOC 2, HIPAA, and GDPR aligned.
For sponsors carrying a blockbuster oncology asset (or a portfolio of approved oncology assets) through postmarket surveillance, lifecycle continuity from the trial-side decision to the postmarket ICSR is the architecture conversation to have.
Phase 1 scoping runs through Q3 2026. Phase 2 co-design runs through Q2 2027. Phase 3 production launch begins Q3 2027. Design partner cohort sponsors lock in launch-window economics before publication-driven price tier shifts.
Sponsors with active trial-side Protocol Safe deployments receive cohort preference.
For cohort scoping conversations later in 2026. Subscribe to the quarterly safety and data quality briefing. Validation readouts, design partner cohort updates, and conference timing only.
No tracking beacons, no marketing email cadence.