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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 · Sample

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

NCT02****** · Global Oncology Sponsor

Phase
3
Enrollment
616
PTII™ v1
84/100
High Complexity
Protocol Complexity (PCI)
87
Operational Burden (OBI)
82
Eligibility Strictness (ESI)
71
Amendment Risk (ARI)
V2
Enrollment Velocity (EVI)
V2
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.

Included in the Study Intelligence Report
Site network expansion recommended

Screening pool narrows sharply at community oncology sites; academic and tertiary sites recommended.

Recommendations, evidence citations & clickable provenanceTier 2 · Report
See the full sample artifact

Demonstration generated by PrismCDM using publicly available ClinicalTrials.gov protocol information. Independently produced by PrismCDM; not 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.

One platform

One platform. Every deliverable.

Four capabilities produce every artifact clinical teams scope today, from protocol through regulatory submission. Same platform, source-backed provenance, regulated audit history preserved end to end.

Clinical Intelligence

Understand every protocol.

Learn more

Execution

Run every study.

Learn more

Evidence

Stay inspection-ready.

Learn more

Provenance & Explainability

Verify every conclusion.

Learn more
From protocol to submission
  1. Protocol
  2. ICF
  3. EDC
  4. SDTM
  5. ADaM
  6. SAP
  7. TFLs
  8. CSR
  9. Submission

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.

Why not just use AI?

AI answers questions. PrismCDM runs regulated clinical development.

The difference isn't the language model. The difference is the operating system.

Starting Point
Starts with prompts.
Starts with protocols.
Output
Produces answers.
Produces traceable clinical intelligence.
Scope
Stops at the response.
Continues through execution, evidence, submission, and inspection.
Provenance
Limited traceability.
Every conclusion is explainable and traceable.
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.

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.