Clinical Development Statistical Strategy
Statistical consulting for clinical development: objectives, endpoints, populations, design options and evidence-generation strategy.
Statistical Analysis Plan Development
We translate the protocol into statistical instructions clear enough to programme, review and interpret study results. Work can cover an initial document or justified, traceable updates.
What you receive
- Authored or updated SAP with tracked changes.
- Endpoint–population–method–output map.
- Open-decision log and study-team review.
What is included
- Define endpoints, estimands, analysis populations and covariates.
- Specify primary and sensitivity methods, missing data, intercurrent events and multiplicity as appropriate.
- Connect the SAP to derivations, dataset specifications and table, listing and figure shells.
Frequently asked questions
How does this differ from SAP & Estimand Risk Review?
This service authors the document. Risk Review evaluates an existing draft and prioritises findings; the two can be sequenced with defined reviewers and responsibilities.
Related services
Study Design, Sample Size & Power
Statistical study design, sample size and power analysis for biomedical research, with documented scenarios, simulation, sampling and randomisation planning.
Trial Feasibility & Enrolment Scenarios
Data and assumption assessment for trial feasibility: eligibility, populations, follow-up and enrolment scenarios subject to validation.
Discuss your project
Tell us about the objective, study stage and deadline. We review the need and availability; we then define the scope with you and prepare a proposal with deliverables, timing and fees.
Do not email patient, clinical or confidential study data. Access and the working environment are agreed before materials are shared.
Discuss your project