SEND 3.1 Datasets & Delivery

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. 

What SEND services do you need?

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 (external contributor data on Covance studies)

Automated Data Delivery

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

SEND datasets and delivery

Where can standardized data take you?

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.

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:

  • General toxicology
  • Carcinogenicity
  • Safety Pharmacology: Cardiovascular & Respiratory 
  • Note: 
    • Non-GLP studies included in a regulatory submission also require SEND format
    • 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?

  • Data Analysis: You need software to be able to view the datasets--if you're able to use a visualization tool, this makes analysis even easier. 
  • Data Storage: You need a storage and archive solution for warehousing files. 
  • FDA Submission: You need the ability to electornically submit your data to the FDA. 

What do SEND files look like?

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

Why Covance for SEND services?

  • We've been doing SEND datasets since the beginning. Today, we've delivered more than 125 billion data points in the SEND format, helping hundreds of companies submit their eCTDs.
  • Covance is part of the CDISC SEND Consortium and FDA/PhUSE Working Groups that are developing SEND standards and terminology
  • Covance uses Pristima® software and Pinnacle 21 for high integrity.