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SEND and DART datasets

Achieve compliant and secure FDA (eCTD) submission requirements with accurate and timely SEND datasets. Labcorp 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.

  • Submission-ready datasets

  • Standardized data across studies

  • Data delivered on your schedule

YES. The Standard for the Exchange of Nonclinical Data (SEND) is more than just a submission format.

Wish all your past study data was available in SEND format?  Know that Labcorp can convert your legacy studies, even if those studies happened before SEND was required. Imagine analyzing data from multiple studies, comparing data with historical controls, or identifying trends and anomalies with ease. SEND also makes it possible to share clear visualizations with stakeholders for improved communication. Contact us to convert your legacy study data sets today. 

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. 

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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. 

 

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)
  • 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 producing SEND datasets since the beginning, contributing to the FDA submissions of hundreds of sponsors.
  • We are part of the CDISC SEND Consortium and FDA/PHUSE Working Groups that are developing SEND standards and terminology
  • We use Pristima® and Pinnacle 21™ software for reliable compliance, quality, and integrity.

Let's start a conversation