The Standard for Exchange of Nonclinical Data (SEND) provides preclinical study data standards that will allow for a more consistent and streamlined review process by the US FDA. In general, SEND formats apply to studies started after Dec. 17, 2016 for NDAs, BLAs, and ANDAs, and studies that start after Dec. 17, 2017 for INDs.
EPL is fully prepared to provide our clients with SEND-compliant datasets. EPL has validated the Ascentos™ pathology information management system and the TranSEND™ software solution by PDS Life Sciences. Through the use of the TranSEND™ software, EPL is able to provide SEND-compliant datasets that are ready to be used for submission to the FDA.
EPL is always committed to meeting and exceeding our customer needs. Being able to provide high quality SEND datasets is an essential piece in supporting our clients’ regulatory submissions.
For additional information on PDS Life Sciences, TranSEND™, and Ascentos™, please visit http://www.pdslifesciences.com