Every biometrics deliverable K3 produces is built for the reviewer who will read it: statistically sound, CDISC-conformant, and documented so the logic is traceable end to end. Our teams are deliberately senior — the statistician who scopes your study leads it, and the programmers who build your datasets validate each other's work independently.
We support standalone deliverables, full-study biometrics, and rescue work on programs that have fallen behind. For interim analyses and DSMBs, a firewalled team maintains the blind.
What we deliver
- Statistical Analysis Plans — estimands, methods, and shells authored to ICH E9(R1)
- SDTM & ADaM datasets — CDISC-conformant with Define.xml, clean through validation
- Tables, listings & figures — double-programmed and independently QC'd
- Submission packages — ADRG, SDRG, reviewer's guides, eCTD-ready structure
- DSMB & interim support — closed-session outputs from a firewalled team
- Adaptive design consulting — sample size, simulations, and regulatory strategy
How we engage
FSP — a standing biometrics function with governance, SLAs, and capacity planning. Project-based — this scope, one accountable lead, priced to the outcome. Resourcing — senior specialists embedded in your team, compliance-current from day one.
A stalled Phase III oncology submission, back on timeline in weeks
A mid-size sponsor inherited a delayed biometrics package from a departing vendor eight weeks before a planned submission. K3 assumed scope without resetting the clock. SPARC →
Works with
Optional acceleration
Run this engagement on SPARC, K3's trial automation platform: analysis datasets, TLFs, and validation produced in days instead of months — same statisticians, same review gates.
Our technology portfolio →Classic delivery is the default on every engagement. Platform acceleration is a choice you make — never a condition of working with K3.
At a glance
- Team: senior-level, 92% retention
- Compliance: current, all 50 states
- Systems: designed & validated for 21 CFR Part 11
- Engagement: FSP · project · resourcing
Put a senior biometrics team on it.
Send the protocol, the RFP, or just the problem. Named people and a scoped approach in return.
Contact K3