EPS features

High Capacity

We own the largest resources in Japan.

Expertise

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.

Services

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

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.