发送3.1数据集和交付

Achieve compliant and secure FDA (eCTD) submission requirements with accurate and timely SEND datasets. Covance continues to be a leader in the development of SEND (Standard for the Exchange of Nonclinical Data), including being an active contributor in the SEND CDISC Consortium and the FDA / PhUSE working groups.

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提交就绪数据集

Standardized data across studies

超过1250亿个数据点

What SEND services do you need?

选择何时接收发送数据集。你想让他们和你的期末报告同时发表吗?或者你更喜欢在整个学习过程中不断地接受它们?

核心服务(3.0和3.1)

  • 提交就绪数据集
  • 审判摘要(TS)文件
  • BA/TK数据转换(external contributor data for our studies)

Automated Data Delivery

尽可能频繁地接收数据(直到每天),以帮助您在研究期间做出更明智的决策。

标准化数据可以带你去哪里?

Imagine analyzing data from multiple studies, comparing data with historical controls, identifying trends and anomalies with ease, and then taking action. SEND makes it possible to share results with study stakeholders for improved communication.

And if you have access to data visualization software, you can make your life even easier by creating easy-to-read visualizations and charts of your data.Read this blog post on how to turn your SEND datasets into smart charts and graphs.

发送格式需要哪些研究?

哪些数据集需要在SEND formar中继续转换,但以下是当前需要SEND格式的场景:

  • 一般毒理学
  • Carcinogenicity
  • 安全药理学:心血管和呼吸
  • 注意:
    • Non-GLP studies included in a regulatory submission also require SEND format
    • 提交的遗留研究至少需要一份简化的试验总结(TS.xpt)文件。

发送或接收数据集需要什么?

  • Data Analysis:You need software to be able to view the datasets--if you're able to use a可视化工具, this makes analysis even easier.
  • Data Storage:您需要一个用于存储文件的存储和归档解决方案。
  • FDA提交:你需要能够以电子方式向FDA提交你的数据。

What do SEND files look like?

  • Zip files (transferred via FTP or StudyTracker)
  • Multiple domains (i.e. Body Weight domain) make up one dataset
  • Each domain is in the .xpt format

为什么选择我们发送服务?

  • We've been doing SEND datasets since the beginning. Today, we've delivered more than1250亿数据点in the SEND format, helping hundreds of companies submit their eCTDs.
  • 我们是世界的一部分CDISC SEND Consortium and FDA/PhUSE Working Groups正在制定标准和术语
  • We use普里斯蒂马® 软件and Pinnacle 21 for high integrity.

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