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Special data effects that magically reveal your study side effects

by Labcorp Drug Developmentupdated on Friday, May 20, 2022Friday, May 6, 2022

In 2016, the Food and Drug Administration (FDA) made the move to digitization by requiring the collection and submission of datasets for nonclinical studies to be filed electronically in a standardized, consistent format. Known as the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND), this …

SEND test submission with Covance. Photo of binary code

Using data visualization tools on SEND datasets: a graph is worth a thousand data points

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Monday, May 20, 2019

SEND [Standard for Exchange of Nonclinical Data] is more than just a tool to facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and …

What’s changing in SEND 3.1?

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Tuesday, May 14, 2019

The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, “SEND 3.1,” changes the model for the reporting of cardiovascular and respiratory endpoints. SEND 3.1 became effective 15 March 2019 for NDA/BLA submissions; and it will become effective 15 March 2020 for IND submissions, overlapping with the effective period of the previous version, …

PK/PD Modeling and Simulation – A Brief Overview and Upcoming Blog Series

by Josh Fohey, BSupdated on Wednesday, July 7, 2021Thursday, November 9, 2017

The year I graduated from college was the same year an old family friend was retiring. He had spent the majority of his career designing and deploying farm equipment across the United States. When I asked for advice as I entered the workforce he told me a story. Three months …

5 Things to Know About the Evolving Requirements For SEND

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Thursday, October 26, 2017

As our industry approaches the one year anniversary of the implementation of SEND (Standard for the Exchange of Nonclinical Data) datasets as required by the FDA for regulatory submissions, attention is shifting to the next set of requirements. From recent notices to upcoming compliance dates, we’ve compiled five key highlights …

Accelerating FDA Submissions with the Trial Summary Domain

by Labcorp Drug Developmentupdated on Sunday, March 29, 2020Thursday, October 26, 2017

A Trial Summary (TS) domain represents an essential part of standardizing study data for electronic submissions. In July 2016, the U.S. FDA issued version 3.1 of the Study Data Technical Conformance Guide, which advised including a TS domain to identify the study start date in the submission. In clinical studies, …

The Tale of a Real-life SEND Test Submission

by Megan Bausman, Lead, Global Data Management Solns. & Rachel Harper, Nonclinical Data Assoc. and SEND SMEupdated on Wednesday, May 19, 2021Tuesday, April 26, 2016

What to Expect When Submitting Your First SEND Dataset to the FDA With the December 17, 2016* requirement for the FDA Standard for the Exchange of Nonclinical Data (SEND*) fast-approaching, our SEND action team prepared a dataset for test submission to the FDA. This helped us to better understand the …

SEND is Here. Are you Ready for Data-Driven Decision Making?

by Megan Bausman, MBAupdated on Thursday, April 22, 2021Wednesday, March 11, 2015

There’s no denying that studies are only as strong as their resulting data—and nonclinical studies produce a lot of data. A two-week study can easily generate more than 2 million results, while a two-year study can contain upward of 500 million data points. In an effort to process and easily …