Our Biostatics Team assists our clients in study design, sample size justification, determination of sample size, randomization, CDISC ADaM, statistical analysis (double programming) and preparation of statistical report and also offer statistical consultation services.
Statisticians with Ph.D. in statistics and managers with over 10 years of experience work together to propose the study design optimal for each project and to provide statistical services necessary for IND and NDA submissions, thus addressing the needs of our clients accurately and swiftly.
Development of Study Design Dry-run for Checking Integrity of Statistical Analysis Results
Statistical Analysis Description Generation of Table and Figures (double programming)
Sample Size Justification Statistical Analysis Report
Development of Statistical Analysis Operating Procedure Data Listing
Development of Statistical Analysis Plan (SAP) CDISC ADaM / Define.xml

Development of Randomization Plan

MFDS Inspection Support
Randomization (Adaptive Randomization with IWRS)  

Study Types

491 Projects

Therapeutic Area

491 Projects
[Updated on June 30, 2018]