Services
Strategy and execution from the same senior team.
We help early-stage biotech and pharma teams bridge strategy and execution, combining expert guidance with AI-powered, fit-for-purpose data products.
Execution partnership
A hands-on team that does the work
- FDA-ready SDTM/ADaM, define.xml and TFLs
- CSRs, topline and board-ready packages
- R/Shiny dashboards for data review
- Data ingestion automation and warehousing
- Fixed pricing, no change-order games
Strategic advisory
Fractional senior leadership
- Clinical development planning with AI
- Decision support in the planning phase
- Data standards and regulatory strategy
- Validated SCE design and AI adoption
- Fixed-price projects (for example, an AI adoption pilot) or hourly support (for example, shaping your enterprise AI policy)
We work across your whole data flow, from EDC to the board deck.
AI adoption in biometrics
Adopt AI on evidence, not on hype.
Can AI accelerate SDTM → ADaM → TFL programming while keeping the quality and traceability a regulatory submission demands? We answer that with you, on your own study.
Your programmers approve every output. Nothing is final without human sign-off.
R/Shiny interactive analytics
See your data while there’s still time to act on it.
Built-in AI data assistant: ask questions of your data in plain language, inside the dashboard. Your environment or ours: hosted for you or deployed in your IT environment, with access control for blinded and unblinded audiences.
Try the live apps →Working alongside your CRO
Your CRO runs the trial. You own the answers.
- Site management and monitoring
- Data management and EDC
- Contracted SDTM, ADaM and TFL deliverables
- Study operations
- Independent QC of CRO data deliverables
- Early-look and ad hoc analyses on your timeline
- Data quality monitoring reports
- Interactive dashboards across studies
- Vendor oversight and data standards
No scope overlap. You get speed and an independent view of your data without duplicated work.
Clinical development planning with AI
Make design decisions on the full body of evidence.
The choices you make before first patient in (indication, endpoints, eligibility, sample size) set the cost, timeline and credibility of your entire program.
Competitive trial landscape, endpoint and eligibility benchmarking, and published effect sizes for your power calculations, across your indication in days instead of weeks.
20+ years in clinical data analytics: endpoints chosen now that you can analyze cleanly and submit to FDA later. Your clinical leadership owns the medical judgment. Under NDA from day one.
Statistical computing environments
Validated environments, built by people who’ve built them before.
| Organization | Environment | Scale and timeline | Validation |
|---|---|---|---|
| Gilead | Validated SAS 9.4 grid with SAS EG, US and EU | 300+ biometricians · 1 year | Led PQ execution · IQ/OQ/PQ |
| Roche Diagnostics | Validated SAS 9.4 with SAS Studio on Linux, US and EU | 30+ biometricians · 9 months | GAMP 5 Cat. 4 · IQ/OQ/PQ |
| Aimmune | Validated SAS 9.4, a cloud analytics platform and an analysis lifecycle tool | 15–40+ users · 4–6 months each | GAMP 5 Cat. 4 · IQ/OQ/PQ |
| Alector | R and RStudio Server added to a validated SAS SCE; enterprise Spotfire | 27 clinical development users | Risk-assessed for exploratory use |
Work led by TrapezoidX founders in leadership roles at these companies before TrapezoidX was founded.
What sponsors usually ask us first.
How do you validate AI-assisted outputs?
Every AI-assisted output gets independent QC by a QC agent and a senior programmer, and nothing is final without human sign-off. Each output is logged to its specification, the AI instructions and model version used, and the reviewer.
Can you work alongside our existing CRO?
Yes. Your CRO runs the study; we work on your side of the table, with independent QC of CRO deliverables, early looks on your timeline, data quality monitoring and vendor oversight. There’s no scope overlap.
How do you price engagements?
Execution work is fixed-price for a defined scope, with no change orders. Advisory work is fixed-price or hourly, depending on the project: an AI adoption pilot is fixed-price, while shaping an enterprise AI policy is hourly.
How do you ensure continuity on our program?
Continuity is built in. All code is documented and reproducible in our system, so no deliverable depends on any one person. Our partner network extends the team when a program needs it.
What happens after the scoping call?
We come back with a proposed scope, timeline and price. Work runs under NDA from day one, and if the first deliverable isn’t submission-ready and on the timeline agreed in the SOW, you don’t pay for it.
Not sure which fits? Start with a scoping call.
We come back with a proposed scope, timeline and price. If the first deliverable isn’t submission-ready and on the timeline agreed in the SOW, you don’t pay for it.