Focus On SEND: Standard for Exchange of Nonclinical Data
The US FDA has requested that by end of 2017, Investigational New Drug (IND) submissions will be conducted in a SEND- compliant format as part of its efforts to improve not only the efficiency and quality of the review process, but also the rigor of scientific assessment. Data submission to support New Drug Application (NDA) and Biologic License Application (BLA) filings with FDA has already been mandatory.
Recently Pharmaron has been implementing hardware and software necessary to meet the SEND guidelines. We are in the process to have fully validated the SEND system by the middle of 2017, thereby meeting the timeline set by FDA for regulatory filings. Pharmaron is committed to ensuring full compliance of regulatory requirements and the high quality of studies conducted at our facilities.
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