3.1.1 and DART 1.1 Datasets & Delivery

Achieve compliant and secure FDA (eCTD) submission requirements with accurate and timely SEND datasets. Labcorp Drug Development 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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Submission-ready datasets

Standardized data across studies

Over 125 billion data points

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 ( 3.1.1 and DART 1.1)

  • Submission-ready datasets
  • Trial Summary (TS) File 
  • BA/TK Data Conversion (external contributor data for our 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. 

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

  • General toxicology
  • Carcinogenicity
  • Safety Pharmacology: Cardiovascular & Respiratory 
  • Developmental and Reproductive Toxicology: Embryo-Fetal Development
  • 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 electronically submit your data to the FDA. 

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

Why choose us 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.
  • We are part of the CDISC SEND Consortium and FDA/PhUSE Working Groups that are developing SEND standards and terminology
  • We use Pristima® software and Pinnacle 21 for high integrity. 

Let's start a conversation

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