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Open, governed study infrastructure

One study knowledge base. Every downstream use.

HumanTrue carries sponsor-decided meaning into governed data, role-aware answers, executable logic, and traceable outputs without replacing the operational systems your teams already use.

The study knowledge architecture

Documents become a governed system of knowledge.

Every relationship retains its source, version, rule, QA status, sponsor decision, and downstream dependencies.

  1. Evidence

    Study documents

    Protocol, investigator brochure, SAP, lab manuals, operational materials, feedback, and amendments.

  2. Foundation

    QA'd USDM + extensions

    Deterministic structure, semantic relationships, sponsor libraries, and recorded decisions.

  3. Knowledge

    Governed study context

    Source evidence, versions, review status, dependencies, and approved interpretation.

  4. Use

    Answers + outputs

    Study Assistant, documents, CRFs, system inputs, amendment impact, and simulation evidence.

Private AI architecture

Customer content stays inside a controlled boundary.

HumanTrue runs AI through enterprise cloud services within isolated, contractually bounded environments. Customer data is not used to train models and is not exposed to model makers for their own use.
  • AICPA SOC badgeSOC 2Control environment and diligence evidence
  • HIPAABusiness Associate Agreements available for customers who require them
  • CDISC USDM symbolCDISC USDMStandards-aligned, portable study structure
Learn more about our security practices

HumanTrue controlled environment

  1. Customer content
  2. Private model inference
  3. Governed output
  • EncryptedTLS 1.3+ and AES-256
  • Controlled accessSSO, MFA, and RBAC
  • RecoverableLogging, monitoring, and backups
Customer content is processed by privately deployed models inside HumanTrue's controlled environment, with encryption, access control, and recoverability. No customer-data training · Full source and version traceability

Capabilities

One governed knowledge base for the work of study design and delivery.

HumanTrue creates the answers, documents, plans, structured data, executable models, and system-ready specifications teams need from the same source-linked foundation.

  • USDM 4.0

    Protocol ingestion, semantic modeling, extensions, versioning, sponsor decisions, and downloadable structured output.

    Digital protocols

  • Study plans

    Data management, clinical monitoring, safety, risk, quality, communication, and diversity plans.

  • Participant materials

    ICFs, assents, screeners, recruitment materials, training, study guides, and registry summaries.

  • Analysis and budgets

    SAPs, estimands, ARS-ready metadata, billing plans, budget inputs, and coverage analysis.

  • Global content

    Country-specific variants, plain-language adaptation, multilingual materials, and ISO 17100 translation workflows.

  • Study systems

    Schedule, CRF, edit-check, IRT, CTMS, eCOA, and ePRO inputs tailored to downstream requirements.

  • Study Assistant

    The role-aware interface to the study knowledge base, with structured views and evidence-linked answers.

  • Assurance and simulation

    Protocol QA, USDM fidelity, amendment impact, executable study testing, audit trails, and expert consensus.

Document creation and review

Create the first draft. Keep the evidence beside it.

HumanTrue supports ICFs, SAPs, data management plans, budget plans, study materials, and translations without separating content creation from quality review.
  • Generate from governed study knowledge.
  • Review requirements and validation findings in context.
  • Adapt language, reading level, country, and template.
HumanTrue informed consent workspace showing document review and validation findings
Illustrative product view using demonstration content. Generated materials remain reviewable, editable, and traceable to their source.

Downstream compatibility

HumanTrue is upstream of study operation.

The platform prepares verified study specifications and licensed outputs for the systems that operate the trial. Compatibility and integration scope are confirmed for each engagement. HumanTrue does not replace the EDC, IRT, CTMS, or eCOA platform.
  • Medidata Rave
  • TrialGrid
  • Veeva
  • IRT / RTSM
  • eCOA / ePRO
  • CTMS
  • SAP / ARS

What remains controlled

  • Sponsor owns its study data and study-specific content.
  • HumanTrue retains its platform, reusable schemas, methods, and extensions.
  • Downstream vendors retain their schemas and operational technology.
  • No customer data is used to train or fine-tune external models.

Start with one protocol

Find what your current process cannot see.

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