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, which provides a standardized format for the submission of nonclinical data to the U.S. Food and Drug Administration (FDA) and other regulatory bodies.
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.
A Closer Look at the SEND Timeline
December 18, 2016
The SEND Implementation Guide (IG), SENDIGv3.0, is required for New Drug Applications (NDA), abbreviated new drug applications (ANDA) and some 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 includes new domains for cardiovascular and respiratory safety pharmacology studies.
March 15, 2020
SENDIGv3.1 is required for all IND submissions.
The Future of SEND
It is anticipated that SEND datasets will become required for nonclinical developmental and reproductive toxicology (DART) and genetic toxicology studies in the next several years.
How Do You Use SEND?
Because the need to develop SEND files can begin during the in-life phase of a study, it’s important to consider SEND from the outset of planning a study.
Communicating effectively with sponsor companies is crucial, as they are responsible for submitting data sets, in conjunction with the Electronic Common Technical Document (eCTD) submission. Sponsors should be able to manage the receipt, review, submission and archiving of the data.
To simplify the submission process, there should be clear communication around submission terminology, coordination between the development of study reports and SEND datasets, and proactive communication with third parties to ensure the provision of datasets in preferred formats and reduce the potential for 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.
There are many benefits to SEND. It wholly eliminates the need for data entry by the agency, which accelerates the review process. It enables the use of existing visuals for standardized datasets and facilitates cross-study analyses, visualization and comparison regardless of the sponsor or testing facility. Overall, SEND provides an elegant solution to the efficiency, quality and communication issues experienced with prior methods.
How Can WuXi AppTec Help You?
We are well versed in importing data from clients and outsourced partners to develop validated SEND data packages.
We use the latest technologies for data collection, management and presentation, ensuring that data packages are compliant with U.S. FDA SEND requirements, as well as 21 CFR Part 11.
We use Instem’s Submit v220.127.116.11, DataDefine v2.1.1, Pinnacle 21 Community Validator and Provantis® software, which ensures the correct terms and translations are used as 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, and we provide SEND data sets within 10 business days of the report date.