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The Evidence Platform
Can you keep me inspection ready every day?

Inspection-ready evidence,
continuously assembled.

Every protocol decision, workflow event, reconciliation, signature, query resolution, and approval becomes regulated evidence automatically. Not assembled at the end. Composed as the study runs.

The Inspection Evidence Package combines Clinical Intelligence generated before and during study conduct with operational evidence accumulated throughout execution. Every section is continuously assembled, fully traceable, and inspection-ready from the moment it is created.

  1. 1Protocol Imported
  2. 2Intelligence Generated
  3. 3Execution Started
  4. 4Evidence Added
  5. 5Inspection Ready
  6. 6Submission
Evidence Proof

The regulated document a 21 CFR Part 11 inspection would actually receive.

Inspection readiness is not a document produced at the end of a study. It is the accumulated result of thousands of operational events captured throughout execution.

The Inspection Evidence Package structure shown below is what a real customer's IEP renders inside PrismCDM. 11-section Table of Contents (now leading with Operational Activity), sample section preview, three-role electronic sign-off (Operator, QA, Regulatory) via the §11.50 re-authentication ceremony, five-axis generation footer.

Inspection Evidence Package
Representative · Demo

Representative demonstration. The structure below illustrates how a real customer's Inspection Evidence Package is composed inside PrismCDM. The values shown are representative for demonstration purposes and do not reflect any specific sponsor study managed by PrismCDM.

Representative Study

Phase 3 study · mid-execution draft

Inspection scope
21 CFR Part 11 + ICH GCP
IEP Coverage (representative)
41%Evidence collection in progress · draft and inspection-ready sections shown below
Table of Contents (representative structure)
  1. 1Executive SummaryDraft
  2. 2Study OverviewInspection-ready
  3. 3Protocol IntelligenceInspection-ready
  4. 4Operational ActivityDraft
  5. 5Clinical Data QualityIn Review
  6. 6Amendment HistoryInspection-ready
  7. 7Findings and RecommendationsInspection-ready
  8. 8Provenance IndexInspection-ready
  9. 9Audit TrailInspection-ready
  10. 10Part 11 SignaturesInspection-ready
  11. 11Submission ReadinessLive
4Operational Activity
Draft

Each Inspection Evidence Package combines Clinical Intelligence with operational events accumulated throughout study execution. Every section is continuously assembled, fully traceable, and inspection-ready from the moment it is created.

Section findings (representative)

Findings issued by the Intelligence Engine for this study section, each identified, scored, and traced to the extraction event that produced it.

Section recommendations (representative)

Recommendations connecting findings to operational actions, each cited back to the findings that supported it and carrying priority + expected impact.

Inspection Sign-off Required
OperatorQARegulatory

The three signature roles above are configured per the customer's sign-off policy and captured via the 21 CFR Part 11 §11.50 re-authentication ceremony. Each signature is linked to the evidence hash per §11.200.

Signatures collected upon IEP coverage reaching 100% and all sections marked Inspection-ready.

Generated
Date
Current generation date
Engine
Current platform version
IEP Schema
Current schema
Corpus Snapshot
Current corpus
Build
Current release

Representative demonstration. The values shown are illustrative of the IEP structure PrismCDM composes for customer studies. No specific sponsor study is depicted here.

Why The Status Quo Is Insufficient

Why clinical development needs a new operating system.

Clinical execution is fragmented.

Protocols, execution, evidence, and regulatory preparation live in disconnected systems. The work to keep them in sync absorbs the team's time.

AI without provenance is difficult to trust.

Clinical teams need to understand not only what AI recommends, but how it reached every conclusion. Without that, regulators and reviewers cannot accept it.

Evidence should be generated continuously, not assembled at the end.

Inspection readiness should emerge from daily operations, not become a last minute project before the audit window closes.

Evidence is created

as work happens.

Not reconstructed when an inspection is scheduled.

The Platform Substrate

One Platform. Four Capabilities.

Every artifact is produced by the same platform that powers Clinical Intelligence, Execution, Evidence, and Provenance across PrismCDM. The Brief is not a feature. It is proof of the platform.

Clinical Intelligence

Understand every protocol before execution begins.

Structured findings on complexity, operational burden, eligibility, schedule, and endpoints. Every finding is identified, scored, and traceable.

Execution

Transform protocol intent into operational decisions.

Recommendations connect each finding to a concrete next step. Site selection, screening reach, visit cadence, monitoring focus.

Evidence

Produce inspection-ready evidence continuously.

Every Brief, every workflow event, every reconciliation step generates the regulated evidence inspection teams expect, not assembled at the end.

Provenance & Explainability

Trace every regulated conclusion back to its source.

Engine version, assessment version, build hash, source layer, evidence anchor. Every finding and recommendation is reproducible and verifiable.

From Protocol to Submission

One platform across every deliverable your team scopes today.

The deliverables clinical teams actually build, in the order they build them. PrismCDM produces each one continuously as the study runs, with source-backed provenance and regulated audit history preserved end to end.

  1. Protocol
  2. ICF
  3. EDC
  4. SDTM
  5. ADaM
  6. SAP
  7. TFLs
  8. CSR
Produced by four platform capabilities
Clinical Intelligence
Execution
Evidence
Provenance & Explainability

Every deliverable, the same platform, the same provenance chain.

Who PrismCDM Is Built For

One platform across the entire clinical development sponsor stack.

Sponsors

Standardize how protocol risk is understood across every study in the portfolio.

Biotech

Run the same enterprise-grade Brief on every protocol with a lean clinical team.

CROs

Bring inspection-ready evidence and provenance to every sponsor engagement.

Academic Medical Centers

Generate Briefs for investigator-initiated protocols with the same rigor as industry.

Mid-size Pharma

Operate clinical development with the platform discipline of top-twenty sponsors.

Built for Regulated Clinical Development

Platform Principles

  • Multi-tenant
  • Append-only audit
  • 21 CFR Part 11
  • Role-based access
  • End-to-end provenance
  • Independently versioned engines
Early Access

See how operational events become inspection-ready evidence.

The clearest way to evaluate continuous evidence generation is to put one of your protocols through the platform and walk the resulting Inspection Evidence Package section by section.