TAS::75 0849::TAS FACILITATING THE TRANSFER OF STATISTICAL METHODOLOGY INTO PRA

Dana Pharmaceutical Consulting, Inc., South Orange NJ

Investigators

Abstract

The overall purpose of the project is to create a comprehensive software package of adaptive statistical design and analysis methods for which no computational tools are currently available for use by Contract Research Organizations in clinical trial design and analysis. The goal is to create a modular package that would enable periodic updates. The package will be acceptable for use in projects intended for submission to regulatory authorities and will be validated and documented to be 21 CFR Part 11 compliant.