Standard for Exchange of Nonclinical Data (SEND)
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What is SEND?
SEND is the Standard for Exchange of Nonclinical Data between organizations, including sponsors and their outsourcing partners, for submission to the U.S. Food and Drug Administration (FDA) and other regulatory bodies. It provides a standard format for the submission of nonclinical data to regulators. It is important to note that SEND does not impact data collection processes – only the submission of the data.
Why Was SEND Created?
SEND was created by the Clinical Data Interchange Standards Consortium (CDISC) in 2002 to execute on the Study Data Tabulation Model (SDTM) for the submission of nonclinical studies. The standardization of data presentation significantly reduces the time that regulators spend sifting through reports to identify pertinent data, which accelerates the progress of developmental drugs, thereby reducing costs to developers.
Following CDISC’s successful launch and implementation of SEND in 2003, the U.S. FDA initiated an experimental program to test the method in 2007.
What Are the Timelines for SEND?
December 18, 2016
The SEND Implementation Guide (IG), SENDIGv3.0, is required for New Drug Applications (NDA), abbreviated new drug applications (ANDA) and certain biologics license applications (BLA).
December 18, 2017
SENDIGv3.0 mandates that SEND datasets be used for nonclinical data contained in all Investigational New Drug Applications (IND).
March 15, 2019
SENDIGv3.1 includes 2 new domains for safety pharmacology studies, mandates datasets required for NDA submissions and features improvements to other domains.
March 15, 2020
SENDIGv3.1 to be required for all IND submissions.
How Will SEND Develop Overtime?
Most recently, on March 15, 2019, version 3.1 of the SEND Implementation Guide (SENDIG) was instituted and includes new domains for cardiovascular and respiratory safety pharmacology studies. As of March 15, 2020, SENDIGv3.1 will be required for all INDs. We anticipate that SEND datasets will become required for nonclinical developmental and reproductive toxicology (DART) and genetic toxicology studies in the next several years.
What Are the Steps to Accept SEND? What Do We Do?
Considering the development of SEND files can begin during the in-life phase of studies, SEND is an important consideration during the preparation of study plans. Communicating with sponsor companies is crucial, as they are responsible for the submission of these datasets in conjunction with the Electronic Common Technical Document (eCTD) submission. Your sponsor should be able to manage the receipt, review, submission and archiving of the data. In order to simplify the submission process, there should be clear communications around the submission terminology, coordination between the development of study reports and SEND datasets, as well as proactive communications with third parties to ensure the provision of datasets in preferred formats to reduce any alterations to the data.
With a track record of reliably exceeding industry standards, WuXi AppTec is capable of importing data from other outsourcing partners and clients to develop validated SEND data packages.
What Are the Benefits of SEND?
SEND is an elegant solution to the efficiency, quality and communications issues surrounding prior methods. It wholly eliminates data entry by the agency, thus accelerating the review process, enables the use of existing visuals for standardized datasets and facilitates cross-study analyses, visualization and comparison, regardless of the sponsor or testing facility.
How can we help you?
WuXi AppTec uses the latest technologies for data collection, management and presentation, ensuring that our clients’ data packages are compliant with U.S. FDA requirements for SEND as well as 21 CFR Part 11. We are equipped with Instem’s Submit v18.104.22.168, DataDefine v2.1.1, Pinnacle 21 Community Validator and Provantis® software. Instem’s Submit ensures that we use the correct terms and translations specified by the U.S. FDA and enables the creation of all domains required per SENDIGv3.0.and SENDIGv3.1. Data can be accessed via our Provantis® Portal™ within 24 hours of acquisition. We provide SEND data sets within 10 business days of the report date, two weeks faster than other laboratories.