Skip to main content
Why PrismCDM

Clinical development cannot be solved
by adding AI to existing systems.

It requires a new foundation. One where every conclusion traces back to its source, every artifact is reproducible, and a single substrate produces coherent output across intelligence, execution, evidence, and provenance.

PrismCDM is that foundation.

The Clearest Answer Is The Artifact

The clearest answer to “why PrismCDM”
is what PrismCDM produces.

Look at any PrismCDM Executive Summary and you immediately see what makes PrismCDM different. Structured scoring. Traceable findings. Evidence-backed recommendations. Executive synthesis. Complete provenance. Every element is produced by the same platform.

Executive Summary
NCT02******

Phase III Immunotherapy Plus Chemotherapy Study in Advanced Non-Small-Cell Lung Cancer

Sponsor
Global Oncology Sponsor
Phase
3
Enrollment
616
Executive Assessment
Prism Trial Intelligence Index™v1
Frontline Phase 3 oncology with combination immunotherapy plus chemotherapy
84/ 100
High Complexity
v1 basis
  • Protocol Complexity Index
  • Operational Burden Index
  • Eligibility Strictness Index
Enters in v2 (corpus required)
  • Amendment Risk Index
  • Enrollment Velocity Index
Contributing Sub-Indices
Protocol Complexity Index(PCI)
Available
87/ 100

Combination regimen, mandatory tumor biopsy, multi-arm randomization

Operational Burden Index(OBI)
Available
82/ 100

Visit cadence and procedure load above frontline oncology average

Eligibility Strictness Index(ESI)
Available
71/ 100

Recent diagnosis with no prior systemic therapy narrows screening pool

Executive Bottom Line
Operational burden is driven by combination dosing logistics and tumor tissue requirements during screening. Eligibility narrows the pool to recently diagnosed patients without prior systemic therapy, which constrains enrollment velocity at community sites.
Recommendation previewStudy Intelligence Report

Site network expansion recommended

Analysis of eligibility criteria against the current site network indicates the screening pool narrows sharply at community oncology sites. Adding academic and tertiary community sites is recommended to protect screening volume.

EvidenceFIND-*Recommendations, evidence citations, and clickable provenance are included in the Study Intelligence Report (Tier 2).
Generated
Date
Current generation date
Engine
Current platform version
Assessment
Current assessment model
Corpus Snapshot
Current corpus
Build
Current release

Demonstration generated by PrismCDM using publicly available ClinicalTrials.gov protocol information (NCT02******). This analysis was independently produced by PrismCDM and has not been reviewed or endorsed by the study sponsor.

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.

Don't trust us.

Verify us.

Every recommendation traces to its protocol source, engine version, evidence record, and build.

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.

The Category Difference

Why not just use AI?

Generic AI tools produce answers. PrismCDM produces traceable clinical intelligence. The difference is not the language model. The difference is the operating system.

Output
Generic AI

Produces answers.

PrismCDM

Produces traceable clinical intelligence.

FindingFIND-*(schema)
Provenance
Generic AI

No source. No chain of evidence.

PrismCDM

Every finding and recommendation traces back to its source.

RecommendationREC-*citesFIND-*
Starting Point
Generic AI

Starts with prompts.

PrismCDM

Starts with protocol structure and engine versioning.

EngineRuntime generated
AssessmentRuntime generated
BuildRuntime generated
Read the full comparison
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

Bring a protocol. Bring a question.

The most useful first conversation is not a sales pitch. It is an honest look at one of your protocols through the platform, with every finding, recommendation, and provenance trail open to your team's scrutiny. That is how PrismCDM earns the foundation conversation.