For Pharmacovigilance Teams · Postmarket PV Module 2027

Built upstream of where case management can help.

Argus, Veeva Vault Safety, and ArisGlobal manage cases after attribution is already made. Burna lives upstream, where investigators decide whether an adverse event belongs to the regimen, the investigational drug, the disease, or a confounder. The same grading pass produces the CTCAE grade the trial database needs and the MedDRA LLT code your team needs.

Book a 30-minute conversation Download the postmarket PV technical brief

Twelve specialized agents in a patented cascading constraint pipeline. WHO-UMC and Kramer attribution with visible reasoning. MedDRA v28.0 LLT codes on every graded event. 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.

PositionUpstream of case management

OutputCTCAE v6.0 + MedDRA v28.0

PV module2027 design partners

Up to 1M ICSRs

Per year, that a blockbuster oncology asset can generate. Phase 1 first-in-human through 20+ years of postmarket surveillance, the same citation discipline at every stage.

31–36%

Of investigator-assigned attributions changed by central review today. Hillman, JCO 2010. Le-Rademacher, Annals of Oncology 2017. Burna closes the gap with named-algorithm attribution at the point of clinical encounter.

11%

Of deaths in oncology, attributable to poor adverse event management. The patient-impact reason safety data integrity is a clinical outcome, not a paperwork outcome.

ICSR ADJUDICATIONPre-processed case in five minutes, not twenty-five.

25 min today5–7 min with Burna

01AUTO

ICSR INBOUND

MAH portal · literature · social listening · HCP report

02AUTO

TRIAGE · MEDDRA

Coded with citation back to the reporter narrative

03AUTO

NARRATIVE DRAFT

WHO-UMC or Kramer attribution path attached

04HUMAN GATE

SMO ADJUDICATES

Safety Medical Officer adjudicates a pre-processed case

SYSTEM OF RECORD

ArgusVeeva Vault SafetyArisGlobal

AI suggests · Safety Medical Officers decide · human-in-the-loop, always

The Architecture

Built for the Safety Medical Officer desk.

A clinical site submits an SAE. The case lands at the desk of an SMO who has six other cases open. The attribution decision was made by an investigator who saw the patient last week. The SMO either accepts the attribution or escalates it. The architecture Burna is building is built for that desk.

Every Safety Medical Officer reading this page already knows the rhythm. The attribution is the decision that downstream pharmacovigilance inherits. Burna is built upstream of where pharmacovigilance can help.

BLOCK 1

Lifecycle scale

Scale that meets the asset

A blockbuster oncology asset moves from ten thousand trial patients to three hundred thousand-plus per year postmarket the day it is approved. 21 CFR 314.80 is a permanent obligation. Burna scales with the asset, from first-in-human safety reporting through commercial-scale ICSR processing, with the same citation discipline at every stage.

BLOCK 2

Upstream

Defensibility upstream of case management

Veeva Vault Safety, Argus, ArisGlobal, and offshore vendors manage cases after attribution is already made. Burna lives upstream, where investigators decide whether an adverse event belongs to the regimen, the investigational drug, the disease, or a confounder. Cross-site attribution consistency surfaces in real time, with named WHO-UMC or Kramer reasoning visible to monitor, sponsor, and regulator.

BLOCK 3

Regulatory

Regulatory tailwind, met with rigor

FDA EDSTP (launched 2024) explicitly invites AI-assisted ICSR triage. EMA GVP Module VI revision moves the same direction. The FDA 2025 guidance on credible evidence in adverse event attribution rules out black-box models. Burna is built for that regulatory standard from day one. Eligible for the CDER Emerging Drug Safety Technology Program.

Bilingual output

The CTCAE grade and the MedDRA LLT code in one pass.

Your team pays for MedDRA coding labor separately from CTCAE grading today. Burna produces both inside the same encounter. The trial database gets what it needs. Pharmacovigilance gets what it needs. The coder no longer reads the same note twice.

Read the MedDRA coding page →

MedDRA v28.0 at launch

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.

One signed record carries both vocabularies

Every signed grade record carries the CTCAE criterion, the MedDRA LLT code, the source sentence, and the named attribution algorithm. The signature is captured on the encoded record, not on the raw output. Downstream pharmacovigilance, regulatory submission, and trial database all read from the same artifact.

Integration where it counts

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.

Upstream vs. Downstream

The structural distinction that matters.

Burna operates before downstream pharmacovigilance systems can help. The differentiation is structural, not feature-level.

Capability	Burna	Veeva · Argus · ArisGlobal	Offshore vendors	Broad oncology AI
Helps investigators make the attribution decision	Yes	No, downstream case management	Human-dependent	No
Named WHO-UMC and Kramer attribution	Yes	Limited or customer-defined	No	No
Multi-drug regimen profiles (42+)	Yes	No	No	No
Citation-bound CTCAE TERM, CATEGORY, GRADE	Yes	Partial or downstream	No	No
MedDRA LLT code on every graded event	Yes, in same pass	Yes, after separate coding workflow	Yes, manual labor	No
Real-time cross-site consistency	Yes	No	No	No
21 CFR Part 11 and GVP Module VI aligned	Yes	Yes	Partial	No

Lifecycle

The full lifecycle, on one architecture.

From first-in-human through twenty-plus years of postmarket surveillance, the same citation discipline at every stage.

PHASE 1

Trial

Trial phase

Burna deploys as sponsor-tenant Protocol Safe inside your CTMS environment or as a standalone hosted tenant. Coordinator and safety officer workflows are pre-configured. DLT review committees see Burna-graded adverse events with named algorithms and MedDRA codes attached.

PHASE 2

Submission

Submission phase

Every adverse event in the SAE database carries its Burna citation chain. Medical writers include the attribution logic in the CSR appendix. Reviewers read the same chain the original assigner saw. DSUR, PSUR, PBRER, and PADER evidence packages generate from live data, not from a periodic dump.

PHASE 3

Commercial

Commercial phase (PV module, 2027 launch)

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, with a pre-processed case in five to seven minutes instead of building one from scratch in twenty-five. Signal detection surface updates daily. At blockbuster-asset scale, the business case is a spreadsheet.

PHASE 4

Regulatory

Regulatory phase

Audit trail is complete by definition. The same citation discipline runs from first-in-human through twenty-plus years of postmarket surveillance. Eligible for the CDER Emerging Drug Safety Technology Program.

For your CISO, GC, and Head of PV Operations

Architecture, sovereignty, and procurement.

Pre-negotiated, single-document downloads. The 8-page postmarket pharmacovigilance technical brief covers all three for safety IT and procurement review.

Download the 8-page brief →

Sponsor-tenant deployment inside your AWS, Azure, or GCP environment, or as a standalone hosted tenant. Twelve-agent cascading constraint pipeline; every grade requires a source sentence and a CTCAE criterion. Two patents filed.
Downstream PV integration with Veeva Vault Safety, Argus, and ArisGlobal at the case-output boundary. EDC integration with Medidata Rave, Veeva Vault EDC, and Oracle Clinical One out of the box.
Regional residency at launch in 10+ jurisdictions (US, EU, UK, Canada, AU, JP, KR, SG, UAE, KSA). The grading model sees only de-identified clinical text; content-boundary middleware keeps protocol text inside sponsor infrastructure.
MSA, Quality Agreement, DPA, subprocessor list, right-to-audit, source-code escrow option, and 90-day exit and data-export provisions pre-negotiated. 21 CFR Part 11 validation package ships with every engagement. GVP Module VI alignment documented.

FAQ

Pharmacovigilance questions.

The eight we hear most often from PV leadership.

Read the full FAQ →

Does this replace our Safety Medical Officers?

No. Burna accelerates them. SMOs adjudicate every adjudication-worthy case. Burna handles intake, deduplication, MedDRA coding, first-pass grading, and narrative draft. The ratio changes. The judgment stays human. AI suggests; clinicians decide. Human-in-the-loop, always.

How does this differ from Veeva Vault Safety, Argus, ArisGlobal, or Medidata Detect?

Those systems manage cases, workflows, reporting, and submissions after attribution has been made. Burna operates upstream, where the investigator is deciding what caused the adverse event in the first place. Burna integrates with downstream systems; the two are complementary in a sponsor PV stack.

What is your MedDRA coverage?

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.

How does the bilingual CTCAE-plus-MedDRA output work in practice?

Every graded encounter produces a signed record carrying the CTCAE criterion, the MedDRA LLT code, the source sentence, and the named attribution algorithm. The trial database reads CTCAE; pharmacovigilance reads MedDRA; both read from the same record. No separate coding workflow, no second human pass for coding.

What about regulatory readiness? 21 CFR Part 11, GVP Module VI, FDA EDSTP?

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 CSR submissions.

Can we white-label this for our CRO partnership?

Yes. $5M to $20M enterprise pricing for top-10 CRO partnerships. Active conversations underway with three of the top-10 global CROs.

What happens to data sovereignty if we are a multi-region sponsor?

Regional cloud deployments available across 11 jurisdictions. Data does not cross jurisdictions without explicit configuration. Sovereign cloud partnerships in negotiation for Oracle Australia, G42 UAE, and STC Saudi Arabia.

Is this a medical device?

No. Burna is a clinical decision support tool. SMOs and investigators approve every output. The platform does not prescribe, modify dose, or alter care pathways. 21 CFR Part 11, SOC 2, HIPAA, and GDPR aligned.

Final

Talk to the postmarket PV team.

For PV leadership running oncology safety at lifecycle scale, with attribution drift across sites and a MedDRA coding line item that keeps growing, this is the architecture conversation to have.

2027 Postmarket PV Module

Postmarket PV pilot scoping now

Pilot partners scoping in 2026 lock in 2026 economics ($2 to $3 per ICSR run-rate) before publication-driven price tier shifts. The PV module launches 2027; the trial-side platform is in production now and integrates with Argus, Veeva Vault Safety, and ArisGlobal today.

Scope, endpoints, validation evidence, and deployment timeline are defined before kickoff. The Master Service Agreement, Quality Agreement, and Data Processing Agreement are pre-negotiated single-document downloads.

Book a 30-minute PV conversation →See the postmarket PV product page →

For Later in 2026

The quarterly safety briefing

For pilot 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.

Subscribe →

Built upstream of where case management can help.

PositionUpstream of case management

OutputCTCAE v6.0 + MedDRA v28.0

PV module2027 design partners

Capability

Burna

Veeva · Argus · ArisGlobal

Offshore vendors

Broad oncology AI

Helps investigators make the attribution decision

Yes

No, downstream case management

Human-dependent

Named WHO-UMC and Kramer attribution

Yes

Limited or customer-defined

Multi-drug regimen profiles (42+)

Yes

Citation-bound CTCAE TERM, CATEGORY, GRADE

Yes

Partial or downstream

MedDRA LLT code on every graded event

Yes, in same pass

Yes, after separate coding workflow

Yes, manual labor

Real-time cross-site consistency

Yes

21 CFR Part 11 and GVP Module VI aligned

Yes

Partial