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 to “why PrismCDM”
is the thread from protocol to submission.
PrismCDM produces every deliverable clinical teams scope and price today, from the first read of the protocol through the regulatory submission package. Same platform. Same evidence model. Same provenance chain from source to inspection.
- Protocol
Ingested, hashed, and versioned as the source of every downstream artifact.
- ICF
Informed consent workflows generated from protocol context.
- EDC
eCRFs with CDASH labels and controlled terminology, wired to sites and reviewers.
- SDTM
Domain mapping traceable to protocol source with per-field provenance.
- ADaM
Analysis datasets generated with versioned engine and reproducibility ID.
- SAP
Statistical analysis plan produced with the same evidence model as every prior artifact.
- TFLs
Tables, figures, and listings rendered from ADaM under the audit trail.
- CSR & Submission
Clinical study report and submission packet (define.xml, ACRF, SDTM specs, ARG) assembled continuously as the study runs.
Every deliverable, the same platform, the same provenance chain from source to inspection.
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.