Statistical Design and Analysis

Strategic input into clinical development plans

Statistical input and support for clinical trial design, conduct, data analysis, and results interpretation

Support for NDA/MAA filing

Protocol  and statistical analysis plan development

iDMC support

Sample size calculation

Randomization plan design

CRF design and review

Specifications for tables, figures and listings

Statistical reports and appendices

Statistical input to publications

Exploratory analyses

Programming and Writing 

SAS programming

Creating ADaM data specifications

Independent validation of tables, listings, and figures

Writing/reviewing:

       -  Study protocol

       -  Statistical analysis plan (SAP)

      -  NDA/MAA filing documents