This course provides a comprehensive overview of data analysis and reporting in clinical research, covering the full journey from data collection and cleaning to statistical evaluation and regulatory submission. It introduces key concepts such as randomization, statistical analysis planning, and endpoint evaluation to ensure robust study design.

Learners will explore critical analytical methods including intent-to-treat principles, handling missing data, protocol deviations, and techniques like ANOVA and hypothesis testing. The course also covers safety and efficacy data review, interim analysis, and structured outputs such as tables, listings, and figures.

Emphasis is placed on ethical result reporting and the role of biostatistics in Clinical Study Reports and New Drug Applications, including integrated summaries of safety and efficacy. This course is designed for professionals seeking a practical and regulatory-focused understanding of clinical data analysis.