Leveraging the experience of highly skilled professionals with multidisciplinary backgrounds, including medical doctors and experts in pharmacy, nursing, and biotechnology, we support our clients in achieving successful clinical development. By analyzing multiple factors such as scientific validity, regulatory risks, statistical assumptions essential for early trial design, cost efficiency, and schedule management, we minimize clinical risks and propose optimized strategies.

We provide comprehensive services for every aspect of clinical development, from drafting the study synopsis and developing the protocol to establishing a long-term Integrated Development Plan (IDP). To prepare the statistical package required for First-In-Human (FIH) entry, we define statistical methodologies for safety and pharmacokinetic (PK) analyses during Phase I study design.
From the earliest design stage, we incorporate the necessary data collection items and analysis plans into the Statistical Analysis Plan (SAP) to enhance the quality of the Investigational New Drug (IND) application. In addition, we offer expert consultation and support on medical issues arising during clinical trials, helping our clients effectively overcome potential challenges they may face.

We design appropriate clinical trials tailored to the objectives of each clinical phase, integrating statistical methodologies such as inter-group comparison strategies, randomization methods, and blinded designs. We also provide statistical definitions for significance testing criteria as well as primary and secondary evaluation variables. To ensure data consistency and the possibility of integrated analyses in multinational trials, we conduct standardized statistical designs across countries and incorporate requirements for global regulatory approval, thereby securing international acceptability.

To quantitatively analyze and manage operational risks in clinical trial execution, we perform simulation-based quantitative forecasting of operational factors such as patient recruitment rate, dropout rate, and data variability. We also design contingency analysis plans and interim analysis strategies to address uncertainties.

We develop data composition and documentation strategies that incorporate the statistical criteria emphasized by regulatory authorities, such as p-value thresholds and confidence intervals. When necessary, we include supplementary clinical trial designs or follow-up statistical analysis plans to fulfill approval dossier requirements. We prepare data integration strategies for indication expansion and combination therapy development, reanalyzing existing trial results as a foundation for further development. Concurrently, we implement real-world data (RWD) analysis strategies to maximize product value.