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Early Access

The Trusted Operating System
for Clinical Development.

PrismCDM unifies clinical intelligence, study execution, inspection-ready evidence, and end-to-end provenance into one operating system.

Generate protocol intelligence, eCRFs, SDTM, ADaM, submission-ready datasets, and traceable evidence, from protocol through regulatory submission.

Free from a ClinicalTrials.gov NCT. Protocol synopsis and full-protocol analysis available through a 1-hour paid strategy session under NDA.

The First Expression of the Platform

Every platform needs a first proof.
For PrismCDM, that proof is the free Executive Summary.

The Executive Summary demonstrates how Clinical Intelligence, Execution, Evidence, and Provenance work together before a study ever begins. It is not the platform. It is the first artifact generated by it.

The product continues: the Study Intelligence Report extends the analysis. The Protocol Design Workspace transforms protocol intent into implementation. The full PrismCDM Platform carries the same evidence model through execution and submission.

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.

See the full sample artifact
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.

Choose Your Starting Point

Four products. One ladder. Enter where you are today.

PrismCDM is not one product with different inputs. Each tier below is a distinct product with a distinct outcome. Start with the tier that matches where your study is today. Each tier leads naturally into the next.

FreeAvailable now
Tier 1

Executive Summary

Decide whether the study warrants deeper investigation

Input
ClinicalTrials.gov NCT
Deliverable
Executive overview a sponsor, CRO leader, or clinical-development executive can evaluate in minutes: therapeutic area, phase, enrollment, complexity band, top-3 operational risks, top-3 data-management challenges, estimated timeline.
Generate a Free Executive Summary
PaidAvailable now
Tier 2

Study Intelligence Report

Decide what to build and prioritize

Input
NCT or full protocol
Deliverable
Comprehensive analysis with source-cited findings and clickable provenance: operational burden, site complexity, visit schedule, endpoint analysis, full risk analysis, CRF and SDTM recommendations, statistical and monitoring considerations, submission readiness.
Talk to Us About a Report
PaidDesign partner
Tier 3

Protocol Design Workspace

Begin implementation

Input
Protocol synopsis
Deliverable
Build-ready specifications: Schedule of Assessments, eCRFs with CDASH labels and controlled terminology, SDTM mapping, visit matrix, validation rules, medical coding prep, CRF-to-SDTM lineage view, review workflow.
Discuss the Workspace
EnterpriseDesign partner
Tier 4

PrismCDM Platform

Operate the study end to end

Input
Full protocol
Deliverable
End-to-end execution: EDC, validation dashboards, ADaM engine, SAP engine, TFL rendering, CSR engine, submission packet (define.xml, ACRF, SDTM specs, ARG), Part 11 audit trail, human sign-off across every AI derivation. Integrations with existing EDC systems including Medidata Rave and Veeva under active partner development.
Book a Strategy Session

Pricing shared during a strategy session. All paid tiers include rendered provenance and regulated audit history.

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

Start with one protocol.

We'll generate a free Executive Summary, then walk your team through the Study Intelligence Report on your protocol, every finding tied to its supporting source, and show how the same platform continues through the Protocol Design Workspace and the full PrismCDM Platform.