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Protocol Safe is the isolated AI environment for protocol-aware adverse event attribution. Sponsor-tenant by deployment, content boundary middleware by architecture. The same twelve-agent cascading constraint pipeline, the same citation-bound output, the same 21 CFR Part 11 audit trail as every Burna deployment. Two patents filed.
Sponsor-tenant deployment inside your AWS, Azure, or GCP environment. Only structured probability scores cross the sponsor boundary. 42 oncology regimen profiles. 837+ CTCAE criteria. WHO-UMC and Kramer attribution. 21 CFR Part 11 e-signature trail. GVP Module VI aligned. Eligible for the CDER Emerging Drug Safety Technology Program.
The signal flows out. The protocol stays in.
By architecture. Protocol Safe deploys inside your AWS, Azure, or GCP. The same twelve-agent engine as every Burna deployment; the architectural difference is the boundary.
The retrieval agent reads the protocol inside the sponsor environment. Only structured attribution signals (TERM, CATEGORY, GRADE, attribution path, source sentence, confidence) cross the boundary. The protocol text does not.
Scaled to protocol complexity, regimen count, and trial size. Designed for the confidential Phase 1 asset where the protocol itself is competitive IP.
Sponsors running confidential Phase 1 trials have protocols that are competitive intellectual property. The investigator brochure, the dose escalation logic, the biomarker selection criteria, and the regimen combination itself are first-in-class assets that a multi-tenant SaaS context is not the right place to send.
Protocol Safe is the product surface that lets the same citation-bound attribution architecture operate on those protocols without the protocol text crossing the sponsor boundary. A retrieval agent ingests the trial protocol inside the sponsor boundary and informs every attribution decision the engine makes. Only structured attribution signals cross the boundary. Protocol text never leaves sponsor infrastructure.
The engine is the same proprietary Burna AI engine that powers every other Burna deployment: a patented cascading constraint pipeline of twelve specialized agents. Two patents filed. The audit trail format is identical. The 21 CFR Part 11 e-signature trail is identical. The compliance posture is identical. Protocol Safe is a deployment pattern and a content-boundary posture, not a different engine.
From signed Master Service Agreement to first sponsor-tenant production deployment is typically four to eight weeks, depending on sponsor cloud environment and the number of trial protocols in scope.
Deploy
Protocol Safe deploys as a single-tenant instance inside your AWS, Azure, or GCP environment. Sponsor identity and access management. Sponsor network controls. Sponsor data residency. The engine, the retrieval agent, the orchestration layer, and the audit trail all run inside the sponsor boundary.
Ingest
The retrieval agent reads the trial protocol, the investigator brochure, the regimen dosing logic, and any sponsor-supplied attribution guidance inside the sponsor environment. The protocol context is indexed against the trial's adverse event surface and held inside the sponsor boundary. The model never sees the raw protocol; it sees structured retrieval results delivered at the moment of attribution.
Grade
At the moment a coordinator or safety officer opens an adverse event, the twelve-agent pipeline runs. TERM identification, CATEGORY assignment, Severity GRADE determination, WHO-UMC or Kramer multi-drug attribution path, source sentence citation, and confidence calibration. Each agent's output bounds every downstream agent's valid output space.
Out
Only structured attribution signals cross the sponsor boundary: CTCAE TERM, CATEGORY, severity GRADE, WHO-UMC or Kramer attribution path with per-drug probability scores, source sentence from the clinical note, and confidence calibration. Protocol text, investigator brochure content, and trial-specific intellectual property remain inside sponsor infrastructure.
AI suggests. Clinicians decide. Human-in-the-loop, always.
Different sponsor and CRO environments require different deployment patterns. All three share the same engine, the same audit trail format, and the same compliance posture. The difference is where the engine runs, where PHI sits, and what context the retrieval layer is allowed to reach for.
Multi-tenant SaaS under a Business Associate Agreement. The fastest pattern to stand up. Standard for design partners, community oncology sites, and cancer centers without specific data-residency or governance reason to isolate. PHI is processed in the Burna AI cloud under BAA; data residency is configurable across the regional cloud footprint.
Single-tenant inside the customer's own VPC or controlled cloud. PHI stays in the customer's boundary. The architecture and audit trail format are identical to cloud deployment; only the hosting changes. Used for CROs, large sponsors, and academic medical centers with specific data residency, governance, or sovereign cloud requirements.
Sponsor-tenant inside the sponsor's own cloud, with content boundary middleware between the reasoning surface and the model boundary. PHI stays in the sponsor's boundary. Protocol text stays in the sponsor's boundary. Only structured probability scores cross the boundary. Per-trial agreements.
| Capability | Protocol Safe | Customer-isolated | Cloud |
|---|---|---|---|
| Twelve-agent cascading constraint pipeline | Yes | Yes | Yes |
| Citation-bound output (source + criterion) | Yes | Yes | Yes |
| 21 CFR Part 11 e-signature audit trail | Yes | Yes | Yes |
| WHO-UMC and Kramer multi-drug attribution | Yes | Yes | Yes |
| SMART on FHIR EHR integration | Yes | Yes | Yes |
| EDC integration (Medidata, Veeva, Oracle) | Yes | Yes | Yes |
| Where the engine runs | Sponsor VPC | Customer VPC | Burna cloud (BAA) |
| Where PHI sits | Sponsor boundary | Customer boundary | Burna cloud (BAA) |
| Where the trial protocol sits | Sponsor boundary only | N/A | N/A |
| Content boundary middleware | Yes | N/A | N/A |
| Typical buyer | Pharma sponsor | CRO, large sponsor, AMC | Cancer center, community oncology |
| Commercial model | Per-trial | Per-trial or enterprise | Per-seat or per-trial |
Same engine. Different boundary.
From the Protocol Safe technical briefBurna AI, May 2026 revision
The architectural continuity is the point. Protocol Safe is not a different product from standard CTCAE Grading; it is the same product with a different boundary posture. The twelve-agent cascading constraint pipeline is identical. The citation requirement is identical. The 21 CFR Part 11 e-signature trail is identical. What changes is where the engine runs, where PHI sits, and what the retrieval agent is allowed to reach for.
The change is architectural, not feature-level. Two patents filed cover the pipeline; the boundary posture is a deployment configuration of the same patented architecture.
The Protocol Safe technical brief covers architecture, data flow, compliance posture, and procurement artifacts for sponsor IT and procurement review.
Download the technical brief →Sponsor-tenant deployment inside AWS, Azure, or GCP. Single-tenant by default. Sponsor identity and access management. Content boundary middleware ensures only structured attribution signals cross the sponsor boundary; protocol text, investigator brochure content, and trial-specific intellectual property stay inside sponsor infrastructure.
PHI stays inside the sponsor boundary. The grading model only sees de-identified clinical text. Regional cloud footprint at launch: US, EU (Frankfurt, Dublin, Paris GDPR-resident), UK, Canada, Australia, Japan, Korea, Singapore, UAE, KSA. Customer data is processed for inference only. No model training on customer data without explicit written consent. Ever.
HIPAA aligned, with BAA executed at deployment. 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. AES-256 at rest, TLS 1.3 in transit. MSA, QA, DPA, subprocessor list, insurance, right-to-audit, source code escrow option, and 90-day exit provisions are pre-negotiated single-document downloads.
Protocol Safe is sold as per-trial agreements. Pricing scales with protocol complexity, regimen count, trial size, and the number of participating sites. Multi-trial portfolio agreements are available for sponsors running three or more active oncology programs.
Most sponsors recoup year-one cost on a single multi-site trial through query labor compression alone.
Veeva Vault Safety, Argus, and ArisGlobal manage cases, workflows, reporting, and submissions after the attribution decision has already been made. Protocol Safe operates at the point where the investigator is deciding what caused the adverse event in the first place.
| Capability | Protocol Safe | Veeva · Argus · ArisGlobal | Offshore vendors | Broad oncology AI |
|---|---|---|---|---|
| Helps investigators and SMOs 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 |
| Real-time cross-site consistency | Yes | No | No | No |
| Sponsor-tenant protocol boundary | Yes | N/A | No | No |
| 21 CFR Part 11 and GVP Module VI aligned | Yes | Yes | Partial | No |
“The attribution decision is where pharmacovigilance starts, not where it ends. Burna positions the work upstream of where Argus, Veeva Vault Safety, and ArisGlobal can help. That is the structural distinction that matters for sponsor pharmacovigilance and for FDA review.”
Dr. Stefan GluckFormerly Vice President at Celgene; Chief Medical Officer at RNA Diagnostics
The eight questions we hear most often from sponsor PV leadership.
Customer-isolated is single-tenant inside the customer's VPC, with PHI staying inside the customer boundary. It is the right pattern for CROs, large sponsors, and academic medical centers that need data residency or governance isolation. Protocol Safe goes one step further: a retrieval agent ingests the trial protocol inside the sponsor environment, and content boundary middleware ensures only structured attribution signals cross the sponsor boundary. The protocol text itself never leaves sponsor infrastructure.
Only structured attribution signals. CTCAE TERM, CATEGORY, severity GRADE, WHO-UMC or Kramer attribution path with per-drug probability scores, source sentence from the clinical note, and confidence calibration. The audit envelope format is identical to every other Burna deployment.
The trial protocol, the investigator brochure, the dose escalation logic, the regimen combination, any sponsor-supplied attribution guidance, PHI from the clinical note, and the indexed retrieval context built from the protocol. The model never sees the raw protocol; it sees structured retrieval results delivered at the moment of attribution.
Those systems manage cases, workflows, reporting, and submissions after attribution has been made. Protocol Safe operates upstream, where the investigator and the Safety Medical Officer are deciding what caused the adverse event in the first place. Protocol Safe integrates with downstream pharmacovigilance systems; the two are complementary in a sponsor PV stack.
Yes. EDC writeback to Medidata Rave, Veeva Vault EDC, and Oracle Clinical One out of the box. Downstream PV integration with Veeva Vault Safety, Argus, and ArisGlobal at the case-output boundary. The structured attribution signals that cross the sponsor boundary land in the formats your existing pharmacovigilance stack expects.
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.
No. Burna is a clinical decision support tool. Safety Medical Officers 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.
Scoping conversation is thirty minutes. From signed Master Service Agreement to first sponsor-tenant production deployment is typically four to eight weeks, depending on sponsor cloud environment, identity and access management integration, and the number of trial protocols in scope.
For oncology programs with confidential protocols, sponsor data-residency requirements, or attribution defensibility concerns upstream of pharmacovigilance case management, Protocol Safe is the architecture conversation to have. Scope, endpoints, validation evidence, and deployment timeline are defined before kickoff.
The 2026 design partner cohort accepts Protocol Safe scoping conversations through the end of Q3 2026.
The Master Service Agreement, Quality Agreement, and Data Processing Agreement are pre-negotiated single-document downloads.
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.