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PrismCDM

Enterprise architecture, right-sized to your first program.

Built For CEOs, Chief Medical Officers, Heads of Clinical Operations, Heads of Regulatory

Biotech companies operate clinical programs where one program is the company. Every operational shortcut is a strategic risk. Every operational over-build is a runway problem. PrismCDM is the regulated operating substrate built for that stage: the same architecture the largest sponsors use, scoped to your program.

The biotech operating problem.

One program is the company. Every operational shortcut is a strategic risk. Every operational over-build is a runway problem.

  • A single program represents the entire company; every operational decision is a strategic one.
  • Hiring a full operations function for one or two studies is over-built; outsourcing every function makes the substrate fragmented.
  • Investors and acquirers expect inspection-ready posture from day one, not at the end of execution.
  • AI tools introduce inspection risk faster than they accelerate the program.

The substrate large sponsors use. Right-sized to your stage.

PrismCDM is the same regulated operating system whether the company runs one program or a hundred. Biotech companies get the same architecture, scoped to the program, without the operational over-build.

Built for lean teams

PrismCDM allows a small clinical organization to operate with the discipline of a much larger sponsor. The platform standardizes Trial Intelligence, execution, evidence, and submission without requiring a large internal operations organization.

Trial Intelligence on every protocol

PTII™ composite and sub-indices on every version of the protocol. Amendment risk, eligibility strictness, and enrollment velocity surface before they become operational issues.

Inspection ready by default

Continuous evidence accumulation across the program. When the investor, the acquirer, or the regulator asks, the Inspection Evidence Package is one click away.

Regulated AI without inspection risk

Every value carries an evidence classification, every artifact carries integrity anchors. Your team can use AI on the program without inheriting the inspection risk of an AI assistant.

Works alongside your CRO

Operate the substrate yourself, give the CRO scoped access, or let the CRO operate on your behalf. The substrate is the same in any configuration. Many vendors try to replace CROs; PrismCDM lets you run both on the same substrate.

Grows with the program

PrismCDM grows with the program from IND through submission without requiring a platform replacement as the company scales. The substrate is the same in Phase 1 as in Phase 3 as in commercialization.

Operational history you can defend

Four-anchor integrity chain on every artifact. Acquirers, partners, regulators, and investors can independently validate your operational history. Nothing is reconstructed during diligence.

One substrate. Every stage of the company.

PrismCDM is the substrate underneath the program from the earliest research through commercialization. Same architecture in Phase 1 as in submission as in due diligence.

  1. Seed
  2. Preclinical
  3. IND
  4. Phase 1
  5. Phase 2
  6. Phase 3
  7. Submission
  8. Commercialization
  9. PrismCDM (the substrate underneath)

Outcomes a biotech leadership team can measure.

  • Trial Intelligence on every protocol, generated by the same engine for the life of the program.
  • Continuous evidence accumulation across execution, ready for investor or regulator review on demand.
  • Inspection Evidence Packages generated without standing up a dedicated submissions function.
  • Operational maturity demonstrable to investors, partners, and regulators throughout the life of the program.
  • A regulated home for AI that does not introduce due-diligence risk.
  • A platform that scales with the company through Phase 2, Phase 3, submission, and inspection.

What biotech leadership remembers after the room clears.

Three reasons biotech leadership adopt PrismCDM. The reasons their leadership teams remember after the room clears.

Enterprise architecture

The same regulated operating substrate the largest sponsors use, scoped to your program. Built once, used for the life of the company.

Right-sized to your stage

You are buying enterprise architecture, not enterprise overhead. The platform standardizes operations without requiring a large internal team.

Diligence-ready every day

Operational maturity is now part of fundraising, partnering, and acquisition diligence. PrismCDM helps demonstrate that maturity from the beginning of the program instead of reconstructing it later.

Start with your protocol

Don't build infrastructure you'll outgrow.

Generate a free Executive Summary on a public ClinicalTrials.gov study, or bring your lead program for a guided Strategy Session under NDA. See the substrate the company will operate on from IND through commercialization.