The Trusted Operating System
for Clinical Development.
Clinical development is the most consequential, most regulated, and most fragmented operation in healthcare. Protocols become studies. Studies become regulated data. Regulated data becomes submissions. Submissions become approved medicines. Every step of that journey runs on a different system, and every handoff introduces friction, inconsistency, and lost context.
PrismCDM connects clinical intelligence, execution, evidence, and regulatory preparation on one operating substrate. One platform. One evidence model. One provenance chain.
Clinical development has evolved into a network of specialized systems. No operating system connects the work end to end.
Intelligence, execution, evidence, and regulatory submission have been treated as separate products rather than parts of the same regulated workflow. Every handoff loses signal and creates rework. Inspection evidence is reconstructed under deadline instead of accumulated as the study progresses. PrismCDM was built to change that.
Make every regulated decision in clinical development
explainable, defensible, and reproducible.
Every artifact PrismCDM produces, from the free Executive Summary through the Study Intelligence Report, the Protocol Design Workspace, and the full PrismCDM Platform, is generated by the same operating system, uses the same underlying evidence model, and shares the same provenance chain.
Four enforceable properties that govern how PrismCDM handles AI-generated and regulated evidence.
These are not marketing principles layered onto the product. They are architectural requirements enforced across the platform. A competitor wrapping the same model cannot make these structural claims about their runtime.
The model operates on the identified source document, not a summary or a reconstruction.
Source Integrity
The source is hashed and verified across the ingestion and execution path, so the protocol presented for inspection can be matched to the protocol used by the system.
Every AI decision terminates in a durable, reviewable outcome.
Outcome Completeness
A decision may be accepted, transformed, superseded, rejected, or escalated. It may not disappear as a silent absence. A generated record, an evidence-backed disposition, or an explicit error. Never a gap.
What you inspect is what production actually ran.
Production–Verification Equivalence
Production, verification, persistence, and inspection operate over one canonical evidence model. The artifact presented for review is derived from the evidence the production system preserved, not reconstructed later through a separate verification path.
No AI evidence is discarded without an explicit, auditable disposition.
Evidence Conservation
Evidence may be transformed, summarized, superseded, rejected, or invalidated. Every disposition is explicit and auditable. Nothing the model produces disappears silently between generation and the record.
Technical descriptions, enforcement status, architecture decisions, and compliance documentation are maintained in the PrismCDM Trust Center.
One platform. Four capabilities.
Every PrismCDM artifact expresses four connected platform capabilities. They are the substrate through which the operating system works.
Clinical Intelligence
Understand protocol structure, complexity, endpoints, operational burden, eligibility, and study risk before execution begins.
Execution
Convert protocol intent and intelligence into controlled operational decisions, workflows, and regulated study activity.
Evidence
Accumulate durable, inspection-ready evidence as the study operates, not reconstructed at the end.
Provenance & Explainability
Trace findings, recommendations, decisions, and regulated artifacts to their supporting sources, evidence records, engine versions, and platform builds.
Advised by practitioners who understand how this work is scoped, operated, reviewed, and purchased.
PrismCDM works with active advisors across biostatistics, clinical operations (oncology and rare disease development), and enterprise clinical software. Their role is practical: challenge product assumptions, test workflows against real clinical-development operations, and ensure commercial decisions reflect how sponsors and practitioners actually scope and buy this work. Advisor identities will be published individually with their approval.
Start with one study.
Generate a free Executive Summary from a public ClinicalTrials.gov NCT. When you are ready to evaluate a full protocol, we walk your team through the Study Intelligence Report, with each finding connected to its supporting source, and demonstrate how the same operating substrate continues through the Protocol Design Workspace and the full PrismCDM Platform.