Clinical data analytics for early-stage biotech & pharma
Alongside your CRO or in place of one. Senior experts do the work, and agentic AI makes them faster. FDA-ready data and decision-grade analytics, from first-in-human to submission.
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Change orders that eat the budget. Senior people who pitch, then hand off to juniors. Timelines that miss the board meeting. Strategy gaps that surface at submission.
Execution partnership
FDA-ready SDTM/ADaM, define.xml and TFLs. CSRs, topline and board packages. R/Shiny dashboards, data ingestion and warehousing. Fixed pricing.
Strategic advisory
Clinical development planning with AI, data standards and regulatory strategy, validated SCE design and AI adoption. Fixed-price or hourly, depending on the project, at 60–70% less than a full-time senior hire.
Drafts code and runs QC at machine speed, against your standards encoded as AI instructions.
Deep CDISC and FDA-submission experience on every output.
Submission-ready from Phase I forward, built to carry into Phase II/III without costly rework.
AI accelerates our team’s judgment. It never replaces it.
Client story
A CMO was reviewing Phase I efficacy data in static slides, weeks before a board update.
“TrapezoidX enabled us to explore our data in a more dynamic fashion, allowing us to make nimble, data-based decisions, while maintaining the integrity of the overall study.”
Live apps
Demo R/Shiny apps on sample data.
Senior people do the work: 20+ years each in early-stage clinical data analysis and reporting, including FDA submissions.
Meet the team →Our guarantee
If the first deliverable isn’t submission-ready and on the timeline agreed in the SOW, you don’t pay for it.
We listen to your program’s challenges and goals, then come back with a proposed scope, timeline and price. Under NDA from day one.
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info@trapezoidx.com · 650-491-4815 · 925-385-8529