Study Design & Protocol Input
Objectives, endpoints, estimands, analysis populations and study-design decisions.
BIOSTATISTICS
Biostatistics Services for Clinical Trials
Statistical support from study design and estimand strategy through analysis, interpretation and reporting packages aligned with the protocol, SAP and applicable regulatory expectations.
SCOPE
From Design to Interpretation
Sample Size & Power
Calculations, assumptions, sensitivity scenarios and documented rationale.
Statistical Analysis Plans
SAP development/review including methods, intercurrent events, missing data and sensitivity analyses.
TFL Shells
Tables, figures and listings aligned before analysis begins.
Statistical Analyses
Longitudinal, time-to-event, responder and other study-specific methodology.
Interpretation & Reporting
Statistical reporting and CSR support, interpretation, and scientific or regulatory review input where in scope.
METHODS
Methodology Organized Around the Question
Longitudinal & Repeated Measures
ANCOVA, MMRM, cLDA and other fit-for-purpose approaches for change over time.
Time-to-Event
Kaplan-Meier, Cox models and event/censoring strategies for deterioration, improvement and related endpoints.
Responder & PRO Analyses
Responder definitions, clinically meaningful change and patient-reported outcome analyses.
Missing Data & Sensitivity
Multiple imputation and sensitivity strategies aligned with assumptions, intercurrent events and the estimand.
Multiplicity & Decision Rules
Hypothesis hierarchy, multiplicity control and prespecified decision logic where required.
Interim / DMC / DSMB Support
Interim analyses and independent data-review support where applicable to the study governance model.