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统计编程
统计编程服务

将统计分析计划落实到FDA认可的格式中

统计编程

方达医药全面的数据编程和分析能力已支持大量临床研究和单独的数据统计项目。我们执行数据分析计划、交付中期和最终分析报告,或将已有数据转换成FDA认可的格式。

  • CDISC实施(SDTM / ADaM数据库)
  • 统计分析和编程支持数据查询、数据库编辑检查和创建分析数据集
  • 为中期分析、数据监测委员会支持、临床研究报告和综合总结报告(ISS/ISE)创建列表、表格和图表
  • 药代动力学和药效学数据分析和建模
  • 电子提交包
    • CDISC 实施(SDTM/ADAM 数据库)
    • 带注释的 CRF
    • SDTM/ADAM Define.pdf 或 Define.xml
    • SDTM/ADAM 审稿人指南
    • 旧数据转换为 SDTM
  • 临床前数据的分析和报告

在开发一种新药时,统计编程是必不可少的。统计编程服务可用于分析产品的安全性、有效性或其他效果。然后将经过验证的数据转换为可解释的信息以进行生物统计分析。

方达 临床服务团队 提供从研究设计到提交最终报告的一整套服务。我们的 生物测量学 团队专注于提供高质量、全面的数据管理, 生物统计学和 SAS 编程服务。

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