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PrismCDM

The platform Big Pharma builds in-house. Without the platform team.

Built For Chief Medical Officers, Heads of Clinical Operations, Heads of Regulatory, Heads of Data Management, Heads of Digital and AI

Mid-size pharma operates multi-program portfolios with the regulatory expectations of Big Pharma and the operational headroom of neither. PrismCDM is the regulated operating substrate that delivers portfolio-level Trial Intelligence, execution, evidence, and submission readiness without the platform-engineering investment. Every new program should extend the operating model, not create a new one.

The mid-size pharma operating problem.

Mid-size pharma carries Big Pharma regulatory expectations on infrastructure that was sized for a single therapeutic area, and on a leadership team that does not have the headroom for a dedicated platform engineering function.

  • Multi-program portfolios on infrastructure that was sized for a single therapeutic area.
  • Big Pharma builds platform engineering teams; mid-size pharma does not have that headroom.
  • CRO partnerships introduce stack variation that internal teams have to reconcile manually.
  • AI adoption is happening per program without a regulated substrate the leadership team trusts.

A regulated operating substrate. Built once. Applied across the portfolio.

PrismCDM is the operating system Big Pharma builds in-house, available without the build. One substrate across every program, every CRO partnership, every therapeutic area, with portfolio-level readiness by default.

The platform without the platform team

Standardize the operating model once. Scale it across every therapeutic area, program, and CRO partnership. PrismCDM is the regulated operating system Big Pharma builds in-house, available without the platform-engineering investment.

Portfolio Readiness

PTII™ composite and sub-indices on every protocol across every program. Leadership sees one portfolio instead of multiple disconnected programs. Amendment risk is visible across the portfolio before the amendment.

Operational follow-through

The same Trial Intelligence drives the execution workspace, the evidence platform, and the submission readiness scorecard. Programs do not get re-interpreted at the handoff between intelligence and operations.

Works with your CROs

Internal teams and CRO partners operate on the same regulated substrate while remaining independently scoped. CROs interoperate without per-engagement stack variation.

Inspection ready every day

Continuous evidence accumulation across every program. Inspection Evidence Packages generated on demand, with complete four-anchor provenance.

AI you can operationalize

Every value carries an evidence classification, every artifact carries integrity anchors, every conclusion is traceable. AI is adopted on a regulated substrate from the start, not retrofitted into one. AI you can put in front of a regulator.

Every new program extends the operating model.

Mid-size pharma grows through additional programs, expanded CRO partnerships, and acquisitions. PrismCDM is built so that each of those does not require a new operating environment.

The Mid-size Pharma Promise

As programs are added, partnerships expand, or acquisitions occur, the operating model remains consistent. New studies inherit the same Trial Intelligence, execution, evidence, and provenance architecture instead of introducing another operating environment.

One operating platform. Every program in the pipeline.

Pipeline
Program A
Program B
Program C
Program D
  1. PrismCDM
  2. Portfolio Dashboard
  3. Submission Pipeline

Outcomes a mid-size pharma leadership team can measure.

  • Portfolio-level Trial Intelligence without the platform-engineering team to build it.
  • Scale operational maturity without proportionally increasing operational headcount.
  • Continuous evidence accumulation across every program, every CRO partnership, every therapeutic area.
  • Inspection Evidence Packages generated on demand for any program.
  • Submission Readiness scorecard that rolls up automatically across the portfolio.
  • A regulated home for AI adopted once, applied everywhere.
  • Reduced operational cost of coordinating CRO partnerships and internal teams.

What mid-size pharma leadership remembers after the room clears.

Three reasons mid-size pharma leadership adopt PrismCDM. The reasons their leadership teams remember after the room clears.

Scale programs

One operating model across every study. Every new program extends the operating model, not replaces it.

Standardize delivery

Internal teams and CROs operate on the same substrate. Stack variation across partnerships goes away.

Prepare for submission

Evidence accumulates continuously throughout execution. Submission readiness is the outcome of operating well, not a separate sprint.

Start with your protocol

Scale the operating model. Not the operations team.

Generate a free Executive Summary on a public ClinicalTrials.gov study, or bring one or more of your programs for a guided Strategy Session under NDA.