Statistical Analysis

About Us

We develop analysis plans and carry out the analysis process based on statistical analysis expertise and extensive experience.

We plan the clinical trial design, set the number of cases, prepare the analysis plan, and analyze and evaluate the collected data.

EPS features

High Capacity

We own the largest resources in Japan.


We provide a variety of specialized services including CDISC standard support, intermediate analysis, implementation of multiple statistical methods, and pharmacokinetic analysis.

Well-established Business

We fully utilize our extensive experience to support regulatory submissions and reexamination applications from the statistical analysis perspective.


Full-Support from statistical analysis planning to analysis results report.

image of Statistical Analysis

With a wealth of experience in clinical trials, post-marketing surveillance and statistical analysis of several clinical studies, we can handle a series of tasks, from protocol development support, creation of deliverables compliant with CDISC standards, implementation of pharmacokinetic analysis, and reporting of analysis results.

Main Services

  • Protocol creation support (description of statistics-related sections, planning of the targeting number of patients and requirement confirmation in compliance with CDISC standards).
  • Statistical analysis plan creation.
  • Creation of analysis dataset, report forms, and various specification documents.
  • CDISC compliant, SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model) and peripheral deliverables creation.
  • Pharmacokinetics analysis (calculation of pharmacokinetics analysis parameters, pharmacokinetics analysis simulation, and the population analysis).
  • Examination and implementation of interim analysis.
  • Statistical analysis implementation for the creation of CTD compliant application materials.
  • Various consulting services regarding statistical analysis operation.