Services

Clinical Project Management

Clinical Operations

Clinical Data Management

Biostatistics

- Clinical Development Plans & Study Design

- Statistical Analysis Plan

- Tables, Figures and Listings

- Statistical Analysis and Reporting

- Quality Control

- Expert Regulatory Support

Medical Writing

Clinical Quality Assurance

Clinical Resourcing

Functional Service Teams

Technology

Biostatistics - Statistical Analysis Plan

A comprehensive statistical analysis plan (SAP) will be developed, which includes the following details:

• Overview of study objectives
• Description of study population
• Sample size rationale and statistical power
• Methodology for summary and analysis of demographic, baseline, efficacy and safety data
• Description of statistical methodology
• Shells of all planned tables, figures, and listings