发送3.1 Datasets & Delivery

通过准确和及时地发送数据集实现柔顺和安全的FDA(ECT)提交要求。Covance继续成为发送发送的领导者(非界限数据交换的标准),包括作为发送CDISC联盟和FDA / PHUSE工作组的积极贡献者。

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Submission-ready datasets

跨研究的标准化数据

Over 125 billion data points

您需要什么发送服务?

Pick when you want to receive your SEND datasets. Do you want them concurrent with your final report? Or do you prefer to receive them repeatedly throughout the course of your study?

Core Service (3.0 & 3.1)

  • Submission-ready datasets
  • Trial Summary (TS) File
  • BA/TK Data Conversion(我们研究的外部贡献者数据)

自动数据传递

Receive your data as frequently as you want (up to daily) to help you make better-informed decisions during the study.

Where can standardized data take you?

想象一下,分析来自多项研究的数据,将数据与历史控制的数据进行比较,轻松地确定趋势和异常,然后采取行动。发送使得可以与学习利益相关者共享结果,以改善沟通。

如果您可以访问数据可视化软件,则可以通过创建易于阅读的可视化和数据图来使您的生活更轻松。阅读本博客文章如何将发送数据集转换为智能图表和图形。

Which studies are required in SEND format?

Which datasets are required to be in the SEND formar continue to shift, but these are the following scenarios that currently require the SEND format:

  • 一般的toxicology
  • 致癌性
  • Safety Pharmacology: Cardiovascular & Respiratory
  • 笔记:
    • 包括在监管提交中的非GLP研究还需要发送格式
    • Legacy studies in a submission will require at least an simplified trial summary (TS.xpt) file for each one.

What's needed to send or receive datasets?

  • 数据分析:如果您能使用a,则需要软件才能查看数据集visualization tool,这使得分析甚至更容易。
  • 数据存储:You need a storage and archive solution for warehousing files.
  • FDA Submission:You need the ability to electronically submit your data to the FDA.

发送文件是什么样的?

  • ZIP文件(通过FTP或StumentTrack传输)
  • 多个域(即体重域)构成一个数据集
  • 每个域都处于.xpt格式

Why choose us for SEND services?

  • 自开始以来,我们一直在做发送数据集。今天,我们已经交付了更多1250亿数据点在发送格式,帮助数百家公司提交他们的专题。
  • We are part of theCDISC发送联盟和FDA / PHUSE工作组that are developing SEND standards and terminology
  • 我们用Pristima® software和Pinnacle 21用于高完整性。

Let's start a conversation

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