The Statistical Analysis Plan (SAP) is based on the trial’s design objectives and key evaluation variables, providing a quantitative standard to scientifically validate the study. Our biostatistics experts contribute from the protocol stage, establishing the trial design and statistical assumptions and proposing analysis methods aligned with the study objectives.

Our biostatistics experts define key reliability elements, including primary and secondary endpoints and analysis populations (FAS, PPS, SAF, etc.), ensuring high-quality statistical analyses. The SAP is optimized to reflect the latest guidance from regulatory authorities, including Korea’s MFDS, the U.S. FDA, and the European EMA.

Statistical analyses are conducted based on a solid understanding of global standards such as those established by the Clinical Data Interchange Standards Consortium (CDISC), tailored to the specific characteristics of each clinical trial. Analysis datasets are generated following CDISC standards, primarily the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), which are mandatory requirements for regulatory submissions. Using structured datasets compliant with international standards, we perform variable mapping and derived variable generation.

Quantitative analyses are carried out according to the Statistical Analysis Plan (SAP), including calculation of effect sizes, confidence intervals, and p-values for key evaluation indicators. Analysis results are visualized through tables and graphs to facilitate understanding and are incorporated into Clinical Study Reports (CSRs) and other submission materials.
To ensure the accuracy and reproducibility of analysis results, we perform double reviews, log file management, and other procedures to manage the quality of statistical analysis.

Statistical analysis results must be interpreted scientifically and presented clearly within the statistical section of the Clinical Study Report (CSR). We provide a balanced explanation of both the clinical relevance and statistical significance of the findings, structuring the report so it is easily understood by both clients and regulatory authorities. We prepare statistical materials for submission dossiers such as INDs and NDAs in full compliance with regulatory requirements, delivering datasets and reports in Common Technical Document (CTD) format. Q&A responses are prepared in advance to address potential regulatory queries. Statistical outputs are also visualized in ways that enable non-experts to understand the results, while supporting the extraction of data‑driven insights.