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    Pharma · Clinical data intelligence

    Clinical data that connects across studies.

    Trial data, safety signals, operational metrics — scattered across EDC, CTMS, safety databases, and labs with no shared context. Fluree connects them into a governed clinical knowledge graph where entities resolve across studies, quality travels with the data, and institutional knowledge compounds instead of disappearing when the database locks.

    Definition

    What is clinical data intelligence?

    Clinical trials generate enormous volumes of structured and unstructured data: demographics, adverse events, lab results, concomitant meds, efficacy endpoints, site performance metrics, safety signals. Each study captures it with its own CRF design, coding conventions, and metadata — and when the database locks, that institutional knowledge disappears.

    Fluree creates a clinical knowledge graph that connects trial, safety, and operational data across your entire portfolio — with governed vocabularies, cross-study entity resolution, and quality-aware lineage.

    Every mapping decision, every entity resolution, every quality annotation compounds — so each subsequent study starts from accumulated knowledge, not a blank page.

    How it works

    Three steps.
    One clinical knowledge graph.

    From fragmented study systems to resolved entities and cross-study answers — with full regulatory lineage.

    Step 1Connect clinical systems.

    EDC, CTMS, safety DBs, labs, eTMF — Fluree reads them in place. No migration, no duplicated data.

    Search sources…AVAILABLE SOURCESMedidata RaveEDC · OAuthVeeva Vault CDMSCTMS · OAuthArgus SafetySafety · databaseLabCorp feedLab · 8.4K results4 studies · 12.8K subjects stagedconnected · ready to query
    Step 2Entities resolve across studies.

    Subjects, investigators, adverse events, meds — golden records with lineage that persist across the portfolio.

    SubjectSiteInvestigatorAEMedication
    Step 3Cross-study answers in seconds.

    Ask in plain language. Every answer traces back to the study, site, and source — with governed clinical vocabulary applied.

    NLMCPRESTSPARQLGrade 3+ hepatotoxicity across oncology portfolio?SPARQL · GENERATEDSELECT ?study ?event ?n WHERE { ?ae a cdisc:AdverseEvent ; cdisc:grade "3+" ; meddra:hlt "Hepatotoxicity" ; cdisc:inStudy ?study .} GROUP BY ?studyANSWERSignal in 3 oncology studiesONC-201ONC-305ONC-412CROSS-STUDY SIGNALAggregate 2.1%traced · 4 studies
    What Fluree Unlocks For Clinical Data

    Six capabilities no single EDC, CTMS, or platform gives you on its own.

    Subjects, investigators, AEs — resolved across your entire portfolio

    Dr. Chen runs sites in three of your trials. An adverse event is coded differently across programs. Fluree matches these to golden records automatically, with confidence scores and full lineage. Cross-study analysis goes from months of manual reconciliation to a query.

    • Subjects, sites, investigators, AEs, meds all resolve
    • Persist across studies — Phase I signals inform Phase III
    • Confidence scores + audit trail on every resolution
    Side by Side

    Traditional clinical data management vs.
    Fluree.

    A direct comparison of siloed CDM approaches against a governed clinical knowledge graph — across the dimensions that drive submission quality and speed.

    Capability

    Traditional

    CDM & platforms

    Fluree

    Clinical knowledge graph

    Cross-study entity resolution

    Manual, months of reconciliation
    Automatic — golden records across every study

    SDTM transformation

    From scratch each study
    Reusable assets — 40–60% faster in the same TA

    Cross-study safety analysis

    Manual aggregate, after the fact
    Graph traversal across the whole portfolio

    Vocabulary governance

    Spreadsheets + per-study conventions
    MedDRA, WHO Drug, SNOMED, CDISC CT in one system

    Data lineage

    Partial, platform-bound
    Immutable, source-to-submission, time-travel

    Unstructured clinical content

    Not handled or limited
    Protocols, SAEs, narratives processed into the graph

    Standards future-proofing

    Manual rework per version change
    Semantic architecture adapts natively

    Data model

    Proprietary formats and APIs
    W3C (RDF / JSON-LD / SPARQL) + FHIR-ready
    In Production

    Global pharma teams — live on Fluree today.

    We’ve seen faster time-to-market as the result of enabling data-driven collaboration — enabling us to capture upwards of $150M in opportunity cost per month saved.
    Gabriel Aviles · Co-Founder, Vitality TechNet
    FAQ

    Clinical data intelligence connects fragmented trial data — from EDC, CTMS, safety databases, and lab platforms — into a governed semantic knowledge graph. It enables cross-study entity resolution, quality-aware data lineage, and reusable transformation assets that make every subsequent study faster and more reliable.

    No. Fluree creates a semantic layer over your existing clinical systems. Medidata Rave, Oracle Clinical One, Veeva Vault, Argus, your CTMS — they all stay in place. Fluree connects to them and creates the cross-study intelligence layer that no single platform provides.

    Fluree matches entities across studies using semantic matching, fuzzy matching, and governed rules. An investigator who appears in three studies resolves to one golden record; an adverse event coded slightly differently across programs resolves through MedDRA hierarchy. Every resolution includes confidence scores and is auditable.

    Yes. Mapping decisions, variable classifications, and controlled terminology applications become reusable knowledge assets. When a new study begins, the system suggests mappings based on your historical patterns — subsequent studies in the same therapeutic area transform 40–60% faster.

    Fluree manages CDISC CT alongside MedDRA, WHO Drug, SNOMED, and your organization’s custom terms, all in one governed system. When CDISC releases new terminology versions, cross-vocabulary alignment manages the transition, so historical data stays connected.

    Yes. FlureeDB’s immutable audit trail logs every data change with timestamps, user identity, and before/after state. Time-travel queries reconstruct any data point at any historical moment, with cryptographic provenance for data integrity.

    Fluree pulls entities and relationships from clinical protocols, SAE narratives, investigator brochures, and other unstructured documents into the same knowledge graph, so a query can span structured trial data and unstructured clinical content together.

    Recognized by Gartner

    Gartner Cool Vendor, Cool Vendors in Data Management: GenAI Disrupts Traditional Technologies, 30 May 2024Featured in a 2024 Gartner Hype Cycle

    Gartner, “Cool Vendors in Data Management: GenAI Disrupts Traditional Technologies,” 30 May 2024. GARTNER and COOL VENDORS are registered trademarks of Gartner, Inc. and/or its affiliates and are used herein with permission. Gartner does not endorse any vendor, product or service depicted in its research publications.

    Clinical knowledge should compound, not restart

    Every mapping, every resolution, every quality annotation — preserved.

    Fluree makes clinical data intelligence cumulative, not disposable — so each study starts from the accumulated wisdom of every study before it.

    Updated