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

该项目的总体目的是创建一个自适应统计设计和分析方法的综合软件包，目前合同研究组织在临床试验设计和分析中还没有可用的计算工具。其目标是创建一个支持定期更新的模块化包。该包将可用于打算提交给监管机构的项目，并将经过验证和记录，以符合21 CFR Part 11。

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.