SEND (Standard for Exchange of Nonclinical Data)
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 +1-650-350-1900 or
by email at 
SEND
v2.3 on CDISC