Clinical data analytics for early-stage biotech & pharma

You don’t need a big CRO. You need the right partner.

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.

Book a scoping call Try our live R/Shiny apps

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Phase I package · QC run Complete
01 Agentic AI drafts code and runs QCdone
02 92 tables checkeddone
03 Senior programmer reviewdone
04 Signed off before it reaches yousigned
< 1 day full QC pass, vs. 3–5 days manually

The X-Factor

Strategy and execution in one team
Faster decisions
24–48h
turnaround on critical analyses
A partner who owns the outcome
A de-risked program
100%
of clients became standing relationships
Senior experts, multiplied by AI
Cost efficiency
0 change orders
fixed pricing, with a reserve for urgent work agreed in the SOW up front

The “safe” choice is often the riskiest one.

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.

Large commodity CRO

Who does the work
Senior people pitch; junior people deliver
Program thinking
Volume-driven; strategic nuance missed
Pricing
Per scope; change orders common
Net effect
Safe on paper, riskiest for the program

Boutique execution shop

Who does the work
A hands-on, execution-focused team
Program thinking
Tactical delivery, limited strategic counsel
Pricing
Hourly
Net effect
Safe for execution, risky for the program

TrapezoidX: strategic partner

Who does the work
Senior experts only, accelerated by AI
Program thinking
Strategy and execution from the same team
Pricing
Fixed price for defined scope, hourly where that fits better. No change-order games.
Net effect
Risk reduced through dual expertise

Two ways to engage. One senior team throughout.

See all services →

Execution partnership

A hands-on team that does the work

FDA-ready SDTM/ADaM, define.xml and TFLs. CSRs, topline and board packages. R/Shiny dashboards, data ingestion and warehousing. Fixed pricing.

Strategic advisory

Fractional senior leadership

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.

AI turns days into hours, without cutting corners.

1

Agentic AI does the heavy lifting

Drafts code and runs QC at machine speed, against your standards encoded as AI instructions.

2

A senior programmer reviews

Deep CDISC and FDA-submission experience on every output.

3

Signed off before it reaches you

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 two-week fix became a 12-month partnership.

A CMO was reviewing Phase I efficacy data in static slides, weeks before a board update.

~2 weeks
Static deck: immediate relief before the board update.
~4 weeks
Interactive R/Shiny tool, built in parallel.
12+ months
The client’s extended programming team, with 3 R/Shiny apps in production.
“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.”
CMO, Series B Biotech
Read the full case study →

Live apps

Don’t take our word for it. Click through.

Demo R/Shiny apps on sample data.

Screenshot: Efficacy data review appEfficacy data review
Trends, change from baseline and heat maps by cohort
→
Screenshot: Safety data review appSafety data review
AEs, labs and vitals, from population to subject
→
Screenshot: Patient profiles appPatient profiles
Every safety domain on one study-day timeline
→
Screenshot: Enrollment tracker appEnrollment tracker
Study operations, site by site
→
Nalin Tikoo
Nalin Tikoo, MS
Co-founder, President & CEO
ex-Roche/Genentech · Alector · BioMarin
Vijay Kumar
Vijay Kumar, MS
Co-founder, Strategic Advisor
ex-Gilead · Aimmune

Senior people do the work: 20+ years each in early-stage clinical data analysis and reporting, including FDA submissions.

Meet the team →

Our guarantee

We’d rather prove it than promise it.

If the first deliverable isn’t submission-ready and on the timeline agreed in the SOW, you don’t pay for it.

Start with a scoping call

We listen to your program’s challenges and goals, then come back with a proposed scope, timeline and price. Under NDA from day one.

Book a 30-minute call

Prefer to write? Send us a note

info@trapezoidx.com · 650-491-4815 · 925-385-8529