top of page
Intertwined

SEND Implementation User Group

The Food and Drug Administration is requesting data in electronic format with IND and NDA submissions to be considered for fast track approvals. The Standard for Exchange of Nonclinical Data (SEND) Consortium is piloting a SEND Implementation Guide (IG) for DART studies. Many Teratology scientists have been involved in creating the DART SENDIG and have been collaborating in harmonizing the Fetal Pathology lexicons across many pharmaceutical companies.

​

The SEND Implementation User Group team, part of the FDA/PhUSE CSS’s Nonclinical Working Group, has announced the SEND Implementation Forum site:

Scientist on Tablet
Science Lab

This site, moderated by the SEND Implementation User Group, allows for members of the industry who are implementing SEND in their organizations to:

  • Ask questions and receive answers from experts

  • Subscribe to keep up to date

This forum is a companion to the SEND Implementation Wiki, which remains an evolving knowledge base resource for SEND Implementation, including:

  • Fundamentals pages – providing entry-level descriptions of fundamental concepts in SEND, such as SEND itself, Controlled Terminology (CT), and Define.xml

  • Getting SEND-ready – with key considerations for new implementers when getting started

  • FAQ – providing a large, evolving list of commonly asked questions

  • (New) News – providing continual updates relevant to SEND implementation, such as FDA and CDISC updates.

Candy Cotton

SUBSCRIBE TO OUR NEWSLETTER

Thanks for submitting!

QUICK LINKS

LOCATION

905 Sheehy Drive Horsham, PA  19044

EMAIL

MARTA graphic logo round.png

MARTA (Middle Atlantic Reproduction and Teratology Association) is a 501(c)(3) tax-exempt organization (Tax ID [EIN]: 47-3896819), incorporated in the state of Pennsylvania. The Association is a regional scientific organization established to foster proficiency and knowledge in the sciences of reproduction and abnormal development/birth defect by acquiring and sharing information with the membership and, when appropriate, individuals outside of MARTA. This is accomplished through programs and communications designed to enlighten MARTA’s membership and those pursuing interests common with MARTA.

bottom of page