SEND Solutions - Standard for the Exchange of Nonclinical Data
The SEND (Standard for the Exchange of Nonclinical Data) countdown to December 17, 2016 has begun. Your move to SEND doesn’t have to be stressful – we can help. Ignite efficiency and achieve fresh insights as you submit nonclinical study data in the FDA SEND format.
Compliance with FDA requirements. A streamlined process.
Get ready. Achieve compliant and secure FDA submissions. With new FDA requirements taking effect on December 17, 2016, you need to be able to receive and submit nonclinical study data in the SEND format for your toxicology studies. Your move to SEND doesn’t have to be stressful. We can help.
Fresh insights. Better decision making.
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 visual results with study stakeholders for improved communication.
Get SEND savvy early. Take a test drive.
You need to know that your SEND datasets are reliable and that your SEND process is going to work. Learn best practices from experts who know the SEND process. Reduce stress by getting ready early. Test drive SEND today with test files and trial FDA submissions.
Experience that matters. Easy, secure implementation.
With Covance, you get a proven SEND partnership and process:
- 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 Pinnacle21 for high integrity. Open SEND.xpt data with SAS Viewer and easily save to spreadsheets. Receive files securely via FTP or Covance StudyTracker®
- Covance successfully delivers SEND today with more than 125 billion data points and greater than 1500 studies performed
Covance is leading the way in SEND solutions with a team of dedicated SEND experts. Learn more about SEND and Covance’s capabilities:
"SEND What to Expect" (Webinar)
Have Concerns about SEND? Join the SEND Discussion Thread
The FDA requires nonclinical data in all submissions for carcinogenicity and general toxicology studies initiated after December 17, 2016, to comply with data standards specifications. Learn more about the new SEND regulatory requirements: