Landmark CRO offers the following biostatistics services:
Study Design And Sample Size Calculation
Statistical Analysis Plan (SAP) And Programming
Statistical Analysis Plan (SAP) And Programming
Study Design And Sample Size Calculation
Landmark CRO helps design the most appropriate and efficient study design for each clinical trial, based on the research objectives, hypotheses, endpoints, and assumptions. Landmark CRO also performs sample size calculation and power analysis, to determine the optimal number of subjects and sites required to achieve the desired statistical significance and precision
Statistical Analysis Plan (SAP) And Programming
Landmark CRO develops a comprehensive and detailed SAP for each clinical trial, which specifies the statistical methods, procedures, and outputs for the analysis of the primary and secondary endpoints, as well as the handling of missing data, outliers, and covariates. Landmark CRO also provides statistical programming services, using validated software and codes, to implement the SAP and generate the analysis datasets, tables, figures, and listings (TFLs).
Statistical Analysis And Reporting
Landmark CRO performs the statistical analysis of the clinical trial data, using the most appropriate and robust statistical techniques, such as descriptive statistics, inferential statistics, survival analysis, multivariate analysis, and meta-analysis. Landmark CRO also provides statistical reporting services, such as preparing the statistical sections of the clinical study report (CSR), writing the statistical analysis report (SAR), and creating the integrated summary of safety (ISS) and efficacy (ISE).
