Service · Statistical Analysis Plan
Statistical Analysis Plans for wearable & digital endpoints
A wearable SAP lives or dies on decisions made before a single model runs: how the endpoint is defined, what counts as a valid wear day, and how missing data is handled. We write SAPs that pre-specify those choices defensibly, so the analysis survives review instead of being rebuilt after it.
What a wearable SAP must nail
The decisions that determine the result
Endpoint definition
Precise, defensible definitions for the chosen sensor metrics — what is measured, over what window, and how it is aggregated.
Wear-time & valid-day rules
Pre-specified compliance thresholds and valid-day criteria, with the evidence base behind them — the choice that quietly decides whether the endpoint is powered.
Estimands (ICH E9(R1))
Treatment effect framed with the estimand structure reviewers now expect, including how intercurrent events and non-wear are handled.
Primary model
MMRM / mixed-effects specification, covariates, and handling of repeated daily/longitudinal measures.
Missing-data strategy
A characterized missingness mechanism and a matched handling approach (not complete-case by default), with a sensitivity battery.
Reliability & interpretation
Where relevant, ICC/MDC and MCID framing so a detected change is both real and meaningful.
Two ways to engage
We can write it, or review yours
Already have a SAP drafted? We also provide independent SAP review and commentary: a sensor-data specialist marks up the wearable-endpoint sections (endpoint definition, wear-time and inclusion/exclusion rules, the primary model, missing-data handling) and flags what a reviewer would question before it locks.
Why pre-specification matters
Get it right before the data locks
Major trials have seen wearable analyses fall apart at review because compliance and missing-data handling weren't planned up front. Pre-specifying the wear-time threshold, the estimand, and the sensitivity battery is what turns a promising sensor signal into a regulatory-grade endpoint. This work pairs naturally with platform-specific analysis for APDM Opal, Garmin & Fitrockr, and actigraphy.
Planning a trial with a wearable endpoint?
Best engaged before the SAP locks. A short call scopes the endpoint, the data, and the plan.
Get in touch