One team, no handoff
The same team writes the SAP and builds the SDTM/ADaM datasets — nothing lost in translation, no reconciliation step before database lock.
Service → Milestone → Deliverable
Biostatistics, milestone by milestone
Select a milestone to see what we deliver at that point in the study.
Why NoyMed
Statistics built to hold up under scrutiny
Every CRO can run a t-test. Sponsors choose the team behind the numbers — how defensible the SAP is under agency review, how clean the handoff to programming and medical writing is, and how few surprises show up at database lock.
Built for scrutiny
Pre-specified, well-documented methods that hold up under DMC, IRB, or agency review — every amendment tracked, every deviation justified.
Connected downstream
Feeds straight into CSRs, medical writing, and pharmacovigilance — no reconciliation step.
Independent DMC/DSMB support
Unblinded reporting kept firewalled from the study team, so the DMC gets objective safety and efficacy data without compromising study integrity.
CDISC-aligned from the SAP forward
Analysis populations and TLF shells specified with SDTM/ADaM structures in mind, so programming never has to reinterpret intent.
Database lock, not database scramble
An independent statistical QC pass before lock is called, plus data management coordination that keeps outstanding items to a short, known list.
Beyond the standard deliverables
Additional biostatistics capabilities
Analysis needs that don't map to a single milestone — available as standalone engagements or layered onto a full study team.
Protocol & design consulting
Study design consultation, statistical input to protocol synopsis, amendment impact analysis, and cross-functional protocol input.
Protocol review & feasibility
Statistical methodology review and endpoint & analysis strategy feasibility before a protocol is finalized.
CDISC & population specifications
CDISC-aligned specifications and analysis population definitions, defined early and held throughout.
PK/PD analysis
Non-compartmental analysis, population PK modeling, and exposure-response analysis connecting dose to effect.
Adaptive & group sequential design
Group sequential design & boundaries and safety monitoring liaison support for the DMC relationship.
Ad hoc & submission support
Ad hoc & exploratory analysis, regulatory query & submission support, and publication & manuscript support.
What sponsors say
Feedback we hear most
Common questions
Before you reach out
What sponsors typically ask before handing over their statistical analysis.
Ready to talk about your analysis plan?
Tell us your study phase, design, and timeline — we'll walk through how our biostatistics team plugs in.