One substrate across the portfolio
Coordinate work consistently across internal teams, CROs, and technology partners. The same Trial Intelligence, the same provenance, the same readiness scorecard, regardless of which CRO is running which program.
PrismCDM
Solutions · Sponsors
One operating system for every protocol, every study, and every submission across your portfolio.
Built For Chief Medical Officers, Heads of Clinical Operations, Heads of Regulatory, Heads of Data Management
Sponsors are managing growing portfolios across internal teams, CROs, regulators, and AI systems that were never designed to work together. PrismCDM is the regulated operating system that unifies Trial Intelligence, execution, evidence, and submission across every program.
What you are up against
The portfolio-level problem.
Sponsors today are coordinating clinical development across more stakeholders, more partners, and more AI tools than any prior generation, on infrastructure that was designed for one program at a time.
- Every program runs on a different stack, so executive readiness rolls up from spreadsheets.
- Executive teams cannot answer a simple question consistently: which studies need attention today?
- Protocol amendments cascade slowly across CROs, sites, and operational systems.
- Evidence is reconstructed in the months before an inspection, not accumulated during execution.
- AI is being introduced one tool at a time without a regulated substrate underneath.
How PrismCDM helps
A single regulated substrate. Across every program.
PrismCDM is not another point tool. It is the operating system that carries Trial Intelligence through to execution, evidence, and submission, on the same substrate across the entire portfolio.
Portfolio Intelligence
Compare protocol complexity and operational burden across every protocol in the portfolio. Executive readiness rolls up automatically. Amendment risk surfaces before the amendment.
Operational Execution
The Trial Intelligence that produces the Executive Summary and Study Intelligence Report drives the execution workspace, the evidence platform, and the submission readiness scorecard. Conclusions never get re-interpreted at handoffs between intelligence and operations.
Inspection ready every day
Evidence accumulates as work happens. The Inspection Evidence Package is generated on demand from the same substrate that ran the study, not reconstructed at the end of it.
Regulated AI
Every value carries an evidence classification, every artifact carries integrity anchors, every conclusion is traceable. Invented data is structurally impossible, not just discouraged.
Standardization without rip-and-replace
PrismCDM complements your existing EDC, CTMS, RTSM, eTMF, SAS, and regulatory systems instead of replacing them. Standardize how protocols are evaluated, how execution is monitored, and how inspection evidence is generated across every program.
The portfolio view
One executive view. Every program.
From every study in the portfolio into one operating substrate, one executive dashboard, one submission readiness scorecard, and one inspection posture.
Portfolio
Study A
Study B
Study C
Study D
- PrismCDM
- Executive Portfolio Dashboard
- Submission Readiness
- Inspection
What you get
Outcomes a sponsor leadership team can measure.
- Executive portfolio visibility from protocol through submission.
- Trial Intelligence generated before the first patient is enrolled.
- Continuous inspection evidence generated throughout study execution.
- Standardized protocol evaluation, monitoring, and submission across every program.
- A regulated home for AI that does not introduce inspection risk.
- Coordinated work across internal teams, CROs, and technology partners on one substrate.
Why sponsors choose PrismCDM
What sponsors remember after the room clears.
Three reasons sponsors adopt PrismCDM. The reasons their leadership teams remember after the room clears.
Portfolio governance
One executive view of every program in the portfolio. One readiness scorecard. One inspection posture.
Standardization at scale
How protocols are evaluated, monitored, and submitted is standardized across CROs, therapeutic areas, and programs.
Regulated AI by architecture
AI adopted on a regulated substrate from the start. No inspection risk introduced by tools added one at a time.