The Statistical Analysis Plan (SAP) is developed based on the clinical trial’s design objectives and key evaluation variables of a clinical trial, serving as the quantitative standard that scientifically validates the trial’s integrity. Our clinical statisticians participate from the Protocol development stage to establish the trial design and statistical assumptions, proposing analysis methodologies that align precisely with the trial’s objectives.

Based on the statistical analysis results and the extensive experience of clinical statisticians, we establish clear analytical criteria in advance regarding other key elements of reliability such as the definition of primary and secondary endpoints and the setting of analysis populations (FAS, PPS, SAF, etc.), thereby enhancing the quality of statistical analysis. Additionally, the SAP’s format and content are optimized to reflect the latest statistical 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. Anticipated Q&A responses are developed 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.