SEND (Standard for Exchange of Nonclinical Data) Consortium is committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of nonclinical data including toxicology, pharmacology and pharmacokinetics data for human, veterinary and food products.

SEND Consortium focuses on development of global, vendor-neutral, platform independent standards to accelerate data reporting and submission to the FDA. The Consortium has representatives from the pharmaceutical industry, contract research organizations (CROs), software vendors and regulatory agencies (FDA's Center for Drug Evaluation & Research - CDER, Center for Food Safety and Nutrition - CFSAN and Center for Veterinary Medicines - CVM). The goal of the consortium is to create a data standard that will be utilized by the industry to submit non-clinical data to the FDA as a part of submission for a new drug, biological, veterinary medicine or food product.

The Consortium holds teleconferences once a month to discuss issues related to development of these standards. Membership in the Consortium is limited to individuals involved in the collection, analysis and/or reporting of animal safety data in the pharmaceutical, biotech, food and veterinary industry. To join the Consortium, please contact Dr. Seema Handu at (650) 210-3963 or by email at shandu@pharmquest.com

SEND v2.3 on CDISC