Statistical Analysis Plan Development
SAP authorship and updates for clinical studies: endpoints, estimands, populations, methods, sensitivity analyses and output specifications.
Clinical Development Statistical Strategy
We help clinical and development teams translate programme decisions into questions a study can answer. Design options are compared with their assumptions and implications for analysis, data and timelines.
What you receive
- Strategy memo with alternatives and a reasoned recommendation.
- Statistical decision, assumption and risk matrix.
- Protocol methodology input and defined next deliverables.
What is included
- Review objectives, target populations, eligibility and clinical or biomarker endpoints.
- Compare designs, covariates, stratification and sample-size and follow-up scenarios.
- Align the protocol, evidence needs and analysis strategy with clinical and regulatory teams.
Frequently asked questions
Can work begin before a complete protocol exists?
Yes. A synopsis and a development decision can support option appraisal. We identify the evidence and agreements needed to finalise the design.
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