Focused engagement
SAP & Estimand Risk Review
A focused methodological review that turns unresolved analysis decisions into a coherent, reviewable statistical strategy.
When to use it
Best fit
Clinical teams with a mature protocol or SAP draft but unresolved endpoint, estimand, missing-data, multiplicity or sensitivity-analysis decisions.
Scope
- Review endpoints, analysis populations and planned methods.
- Assess estimands and handling of intercurrent events.
- Challenge missing-data assumptions, multiplicity control and sensitivity analyses.
- Check consistency between the protocol, SAP and intended outputs.
Inputs
- Protocol, synopsis and current SAP draft.
- Endpoint definitions and estimand proposals.
- Available CRF, dataset specifications or output shells.
- Known regulatory, operational or scientific constraints.
Deliverables
- Structured review memo with prioritised findings.
- Endpoint-to-analysis and estimand decision table.
- Assumptions, risks and open-question log.
- Recommended revisions and sensitivity-analysis strategy.
Data handling
Real patient or confidential study data remains within the client, sponsor, CRO or contractually approved environment. The permitted data, access model and retention rules are agreed before work begins.
Do not send patient, clinical or confidential study data.
Boundaries
- A review engagement does not include full SAP authorship unless separately scoped.
- Does not include complete TLF programming, medical writing or formal regulatory representation.
- Clinical and regulatory decisions remain with the sponsor and its authorised experts.
Discuss this engagement
Confirm fit before sharing materials.
Begin with the study situation, intended decision and timing. Data access is agreed only after scope and safeguards are defined.