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CDISC study-build pricing

Priced per study. Not per seat.

Four-week pilot: one protocol through the CDISC pipeline to Define-XML. Then annual, per-study pricing — unlimited seats for the team that runs the trial.

A senior SDTM programmer costs $130–170K per year. A Phase II study consumes 3–4 months of their time. TrialNexus costs less than one FTE — and it's available for every study simultaneously.

Pilot

One protocol. Four weeks. Full pipeline from Protocol → Define-XML.

On request
Credited toward first study if you continue
  • Protocol → USDM
  • DMP + eCRF draft
  • SDTM + ADaM on sample data
  • Full Decision Queue access
  • Dedicated engineer
Most studies

Study

Full pipeline for an active trial. Study builds in under two weeks.

Custom
Scoped by phase, complexity, duration
  • All seven Core agents, all phases
  • Signal narratives for one study
  • EDC integration (Rave or Vault)
  • SSO + role-based access
  • Part 11 validation package
  • Priority support SLA
  • Unlimited seats

Enterprise

Portfolio-wide. Your stack, your perimeter. Agent Studio included.

Custom
Annual contract · volume pricing
  • Isolated tenant + BYO keys
  • Core + Signal portfolio-wide
  • Agent Studio access
  • Dedicated database + customer-held KMS keys
  • Custom agent development
  • On-prem LLM deployment available
  • Named TAM + architect
What's in the pipeline

A CDISC study-build pilot is the full stack, not a slide.

The four-week engagement runs one protocol through the same agents that production uses. Nothing is mocked for the demo, and nothing is left as a "phase two."

Protocol → USDM

Parser reads the protocol PDF and emits USDM v4.0: arms, epochs, endpoints, and the visit schedule your downstream agents actually consume.

DMP + eCRF draft

DMP Writer and eCRF Builder draft the plan and forms from the USDM, with open decisions flagged for your DM lead instead of buried in comments.

SDTM + ADaM + Define-XML

Mapping, analysis datasets, and a Define-XML package on sample data — Pinnacle 21 checks inline, human sign-off in the Decision Queue.

The numbers

Your finance team does the math here, not after the call.

Drag the slider. See what headcount really costs — and what 8 weeks recovered per study means to a Phase III program.

Studies per year
4

Headcount starts rounding up here.

15101520

$160K/yr · 30% burden = $208K loaded. Each FTE handles ~3 studies. Headcount rounds up.

DM headcount2 FTEs
$416,000
TrialNexus · all studiesunlimited seats
Contact us
Estimated annual savings · 78% cost reduction
$324,000+
Weeks recovered / study
8 wks
68-day build → 12-day build
Revenue runway recovered
$4.8m
1 Ph III study · $600K/week
Common questions

What finance and DM ask before the call.

One protocol, end-to-end: Parser → USDM → DMP → eCRF → SDTM + ADaM on sample data → Define-XML. You get the Decision Queue, a dedicated engineer, and a Part 11 validation package. The pilot fee is credited toward the first production study if you continue.
Per study. The team that runs the trial — DM, ClinOps, Medical, Biostats, Regulatory — all get access. There is no per-seat license. Production is an annual commit scoped to phase, complexity, and EDC footprint.
A Phase I single-center oncology study and a global Phase III adaptive design are not the same product. We scope to your protocol, phase, EDC, and risk profile. Pilot engagements are always fixed-fee. If you want a number, a 30-minute call is enough to give you one.
A senior SDTM programmer costs $130–170K per year, plus burden. A Phase II study consumes 3–4 months of that person's time. TrialNexus is available for every study simultaneously, and the FTE calculator on this page shows the loaded-headcount comparison.
All seven Core agents, Signal narratives for that study, Rave or Vault EDC integration, SSO, a Part 11 validation package, priority support, and unlimited seats. Enterprise adds Agent Studio, an isolated tenant, customer-held keys, and a named TAM.
Build your business case

Putting together a business case?

Our interactive ROI explorer lets you dial in trial complexity, automation depth, and portfolio size — then generates a one-page executive briefing you can take straight to procurement.

Build your ROI estimate →
The honest part

Why no public price?

A Phase I single-center oncology study and a global Phase III adaptive design are not the same product. We scope to your protocol, your phase, your EDC footprint, and the risk profile of your program. Pilot engagements are always fixed-fee. Production engagements are annual commits with unit economics your finance team will recognize.

A senior SDTM programmer costs $130–170K per year. A Phase II study consumes 3–4 months of DM work. TrialNexus costs less than a single FTE, and it's available for every study simultaneously. That is the frame your finance team will use.

If you want a number on a 30-minute call, we'll give you one. That's what the call is for.

A number on a 30-minute call. That's it.

We scope to your protocol, your phase, and your EDC. Pilot engagements are fixed-fee. Production is an annual commit with predictable unit economics.

Send us your study profile