Graffs for Healthcare

From molecule to market.
One intelligent platform.

Clinical trials, pharmacovigilance, regulatory, manufacturing, commercial launch — connected by a Knowledge Graph, secured by Confidential Compute, grounded in evidence. Purpose-built for rare disease, oncology, and gene therapy.

Rare DiseaseGene TherapyOncologyImmunologyCell & Gene

Extensible agent platform

Start here. Build from here.

Purpose-built agents for every stage of pharma — from first-in-human to post-market surveillance. Each one reasons over the Knowledge Graph, validates through Critiquers, and operates within Clinical Guardrails. Need something new? Spin up your own.

Clinical Trial Intelligence

Protocol optimization, site selection, enrollment forecasting

Pharmacovigilance Agent

ADE signal detection, CIOMS/MedWatch automation, interaction monitoring

Regulatory Intelligence

FDA/EMA submission tracking, label change impact, inspection readiness

Medical Affairs Agent

KOL mapping, MSL territory optimization, medical information requests

Commercial Launch Agent

Market access, formulary tracking, payer analytics, launch sequencing

Real-World Evidence Agent

Claims analysis, patient outcomes, comparative effectiveness

Supply Chain & GMP Agent

Batch release, deviation management, cold-chain monitoring

Patient Journey Agent

Time to diagnosis, treatment pathways, adherence, access barriers

Drug Interaction & Safety Agent

KG-powered interaction checks, contraindication alerts, dosing verification

Build your own

Same KG, same guardrails, your logic

HEOR & Outcomes·Companion Dx·Pricing & Access·Medical Writing·Biomarker Strategy

Every agent — including the ones you build — is backed by the Knowledge Graph, validated by Critiquers, and governed by Clinical Guardrails.

Cross-functional intelligence

One platform across the entire org.

Agents don't live in silos. Every function — Commercial, Clinical, Regulatory, Supply Chain — shares context through a single Knowledge Graph. Insights surface across boundaries, not within them.

Inside each function, spin up purpose-built agents that understand the needs of that team — and connect them to every other function in real time.

Shared backbone — Knowledge Graph · Guardrails · Audit Trail

Example: North America Commercial

A VP of Commercial NA spins up four agents — Market Access, Field Force Intelligence, Payer Analytics, and Launch Sequencing. Each agent draws from the same Knowledge Graph and automatically connects to Regulatory Intelligence for label updates, Supply Chain for inventory readiness, and Medical Affairs for KOL insights. No manual hand-offs. No data silos.

4 agents spun up
3 functions connected
1 Knowledge Graph

Single question

“What’s our launch readiness for the new indication across North America?”

Market Access Agent

Pulling formulary status across top 12 PBMs

7 of 12 formularies confirmed. 3 pending prior-auth pathways identified.

Regulatory Intelligence

Cross-referencing latest FDA label update

New indication approved March 2026. Commercial materials need updated claims language.

Supply Chain Agent

Checking inventory readiness for launch territories

Northeast distribution hub at 94% capacity. West Coast needs 2-week lead time.

Medical Affairs Agent

Mapping KOL coverage for launch regions

14 KOLs identified across 8 territories. 3 gaps in Southeast — MSL assignment recommended.

Knowledge Graph

Synthesising cross-agent findings

Launch readiness score: 78%. Two blockers flagged. Recommended actions generated.

One question. Five agents. One synthesised answer.

No manual stitching. No copy-paste across tools. The platform orchestrates.

Platform architecture

Every layer, one view.

From infrastructure to interface — with guardrails and LLMs running the full height of the stack.

Guardrails

Guardrails
Security Posture
Critiquers
Clinical Rules
Confidence Gating
Audit Trail

Interface

Single UserOrganization / Multi-userSecure / FirewallMulti ScreenMulti DeviceFull Scalability

Brain — Agent Building Architecture

Clinical Trial IntelligencePharmacovigilanceRegulatoryMedical AffairsCommercial LaunchRWESupply ChainPatient JourneyDrug SafetyCustom...

Knowledge Graph + Plug-in Architecture

Fine-tuned modelsScaffoldHealthcare ontologiesExtensible plugins

Backplane — Data Source Connectors

FHIROMOPDICOMClaimsClinical NotesPPTExcelDatabasesAPIsMCP

Virtual Storage Layer

KubernetesGPURAMStorageAzure / On-Prem

Pharma Core Technology Base

HIPAAGxP21 CFR Part 11SecurityToken ManagementSOC 2Secure Source Control

LLMs & RAG

Claude
GPT
Mistral
Open Source LLMs
Graffs.io RAG
Integration Engine

Graffs Platform Architecture

Safety architecture

Six layers. One goal: never silently wrong.

Fine-tuning reduces error frequency. The remaining five layers catch what remains. In healthcare, all six work together because the margin for error must approach zero.

Every agent has a critic. By design.

When an agent generates an answer, a specialized Critiquer agent independently reviews the output against the Knowledge Graph, RAG evidence, and clinical rules. Unsupported claims, logical gaps, or dosing inconsistencies trigger revision or escalation before the answer reaches the user.

Agent OutputCritiquer Review (KG + RAG + Rules)
PassReviseEscalate
Pharma example: The Pharmacovigilance Agent drafts a safety signal report. The Critiquer cross-checks every cited ADE against the Knowledge Graph, verifies CIOMS field completeness, and confirms the statistical method. Only then does the report reach your safety officer.
01

Knowledge Graph

Expert-verified drug-disease-gene-pathway relationships queryable by agents.

Every edge curated — not scraped.

02

RAG Document Intelligence

Agents search approved clinical guidelines, FDA labels, and trial protocols before answering.

Citations from your evidence base, not the internet.

03

Critiquers

Adversarial second-opinion agents validate every output against the KG, RAG evidence, and clinical rules.

Multi-agent peer review, not single-pass generation.

04

Clinical Guardrails

Hard-coded rules for dosing limits, interaction severity, and contraindications override the LLM.

Pediatric weight-based dosing without weight input? Blocked.

05

Confidence Gating

Below-threshold answers blocked and escalated to human experts.

Never silently wrong.

06

Audit & Transparency

Complete audit trail of every interaction: sources consulted, agents invoked, guardrails triggered.

Every answer traceable. Every decision logged.

Architecture in action

Watch every safeguard fire on a real question.

Case 01

Drug Interaction Check

"Can I prescribe aspirin to a 68-year-old already taking warfarin?"

FT

Fine-Tuned LLM

Recognises warfarin as an anticoagulant. Formulates a KG query for drug-drug interactions on the "interacts with" edge type. Simultaneously queries RAG for anticoagulation guidelines in elderly patients.

KG

Knowledge Graph

Aspirin → interacts with → Warfarin → increases → Bleeding Risk. Severity: High. Monitoring: INR test required.

RAG

RAG Documents

Returns ACC/AHA guidelines on combination antithrombotic therapy in elderly patients, including risk-benefit assessment guidance.

LLM

LLM Synthesises

Combines KG facts and guideline text — recommends assessing bleeding risk, reviewing whether combination therapy is clinically necessary, and considering gastroprotection when indicated.

G

Guardrail Validation

Clinical rules engine confirms interaction severity matches KG. Source verification checks material claims trace to KG edges and RAG passages. Answer delivered with interaction warning.

Case 02

Pediatric Dosing — Weight Required

"What's the recommended dosage of amoxicillin for a 4-year-old with strep throat?"

FT

Fine-Tuned LLM

Recognises pediatric dosing question. Queries KG for Amoxicillin → treats → Group A Strep with dosage properties. Queries RAG for CDC pediatric dosing guidance.

KG

Knowledge Graph

Returns weight-based dosing: 50 mg/kg once daily (max 1000 mg) or 25 mg/kg twice daily (max 500 mg/dose), for 10 days. Requires patient weight.

!!

LLM Hallucinates

Despite correct retrieval stating weight is required, the model generates "500mg twice daily" — an adult dose, without requesting the child's weight. The rest sounds clinically fluent, making the error harder to spot.

G

Guardrail Catches It

Clinical rules engine detects two violations: (1) fixed-dose without required weight input, (2) 500mg exceeds per-dose maximum for estimated pediatric weight at age 4. Response blocked. System asks for weight. Flagged for human review.

Data Sovereignty

Your data never leaves your boundary. Ever.

Graffs runs inside Trusted Research Environments with Confidential LLMs on Confidential Compute — enabling collaboration without exposure.

Trusted Research Environment (TRE)

Deploy Graffs inside your TRE. Patient data, trial records, proprietary research stay within your sovereign boundary. No exfiltration, no model training on your data.

Example: Run pharmacovigilance on real-world data inside NHS Digital's TRE — not a single record leaves.

Confidential LLMs

Models execute inside hardware-encrypted enclaves (TEEs). Even Graffs cannot see your prompts, data, or intermediate states.

Example: Query gene therapy outcomes across 50,000 records — processed in encrypted memory no operator can observe.

Multiparty Computation (MPC)

Pharma + CRO + hospital + payer contribute data to joint analysis without any party seeing raw data. Only aggregates released.

Example: Three sites pool trial data for cross-site enrollment analysis. Each sees only the aggregate.

Confidential Data Sharing

Share derived insights with partners, regulators, or payers without sharing underlying patient data. Cryptographic attestation proves correctness.

Example: Share RWE with the FDA — they see the analysis and attestation, not the claims data.

Interoperability

Connected to every system you already run.

Built on Microsoft Fabric for Healthcare. Native support for every major healthcare data standard. MCP-enabled for seamless tool and system integration.

FHIR R4 Native

Ingest, query, and reason over FHIR resources natively. EHR data, clinical documents, patient records — all structured and agent-ready from day one.

OMOP / OHDSI

Transform data into OMOP common data model for standardized observational research and comparative effectiveness studies.

DICOM Imaging

Bring medical imaging data (CT, MRI, pathology) into the analytics layer. Agents cross-reference imaging metadata with clinical records.

CMS Claims & SDOH

Ingest CMS CCLF claims data and Social Determinants of Health datasets for real-world evidence, market access, and patient journey analysis.

Unstructured Clinical Notes

AI-powered enrichment of free-text clinical notes. Extract structured entities (diagnoses, medications, procedures) from physician narratives.

MCP (Model Context Protocol)

Open protocol for connecting AI agents to any external tool, database, or API. Your LIMS, CTMS, EDC, safety databases, and ERP become agent-accessible without custom code.

Auto-discover. Auto-structure. Auto-connect.

Graffs auto-discovers data sources, maps schemas to healthcare ontologies (FHIR, OMOP, SNOMED, ICD, RXNORM), and structures them for agent consumption. No YAML. No Python. No consultant. Connect your Azure Health Data Services, Fabric workspace, or on-prem databases — agents start reasoning in minutes.

Other platforms require weeks of configuration and a data engineering team. Graffs requires a connection string.

Why this is different

Not incremental. Structural.

Dimension
Traditional platforms
Graffs for Healthcare
Scope
Commercial analytics only (6 fixed agents)
Full pharma value chain — R&D to post-market (9+ extensible agents)
Safety architecture
"Hallucination-free" via prompt engineering
6-layer evidence grounding: KG + RAG + Critiquers + Clinical Rules + Confidence Gates + Audit
Validation
Single-pass LLM generation
Multi-agent Critiquers independently validate every output against KG and RAG evidence
Configuration
YAML, Python, consultant setup
Auto-discover, auto-structure — zero configuration

In practice

Show me it works.

Scenario 1

Rare Disease Gene Therapy Launch

Launching a gene therapy for OTC deficiency? The Commercial Launch Agent models formulary trajectories across top payers. The Patient Journey Agent maps the diagnostic odyssey from first symptom to confirmed diagnosis. The Medical Affairs Agent identifies KOLs publishing on the condition. The Critiquer validates every projection against historical launch data in the Knowledge Graph. All from a single conversational query — grounded in your FHIR patient data and OMOP-standardized claims.

Scenario 2

Post-Market Pharmacovigilance

A new adverse event pattern emerges post-approval. The Pharmacovigilance Agent cross-references the Knowledge Graph, identifies the signal, drafts a CIOMS II line listing, and escalates to your safety team. The Critiquer verifies signal thresholds, checks field completeness, and confirms the statistical method before the report reaches your safety officer. Minutes, not weeks. Evidence-grounded, not LLM-guessed.

Scenario 3

Multi-Site Confidential Trial Analysis

Three academic medical centers and your CRO need to pool Phase III data for an interim futility analysis — but no site can share raw patient records. Graffs deploys inside each site's TRE, runs the analysis via Multiparty Computation across encrypted enclaves, and delivers aggregate efficacy and safety endpoints to the DSMB. No raw data crosses any boundary. The DSMB receives cryptographic attestation that the computation was correct. FHIR-native. OMOP-standardized. Zero configuration at each site.

Compliance & Trust

HIPAAGxP21 CFR Part 11SOC 2 Type IIGDPRTRE-ReadyConfidential ComputeFHIR R4OMOPDICOMMCPCryptographic Attestation