SEND(Standard for Exchange of Nonclinical Data) was defined and maintained by the SEND team at Clinical Data Interchange  Standards Consortium (CDISC). SEND specifies a way to collect and present nonclinical data in a consistent format. SEND is one of the required standards for data submission to FDA.

The importance of SEND

• SEND datasets are required for single-dose toxicology, repeat-dose toxicology, and carcinogenicity studies initiated after December 17, 2016, that are submitted to CDER in NDAs, BLAs, and ANDAs and for such studies initiated after December 17, 2017 that are submitted in INDs.

• SEND datasets are required for respiratory and cardiovas-cular safety pharmacology studies initiated after March 15,2019, that are submitted to CDER in NDAs and BLAs and for such studies initiated after March 15, 2020, that are submitted in INDs. 

• The Standard for Exchange of Nonclinical Data (SEND)  Implementation Guide-Animal Rule v1.0 (SENDIG-AR v1.0 External Link Disclaimer) was published by CDISC on September 17, 2019, and FDA’s support for these data standards began on March 15,2020. SEND data sets will be required in Animal Rule submissions to the Center for Drug Evaluation and Research (CDER) for studies initiated after either March 15, 2022, or March 15, 2023,  depending on the type of regulatory submission.

• On March 15, 2021, SENDIG-DART v1.1 was added to the  FDA catalog. SENDIG-DART v1.1 supports study data typically found inembryo-fetal developmental (EFD)  toxicity studies and is based on, and should be used in close concert with, SEND v 3.1 and SDTM v1.6. For studies expected to be initiated after March 15, 2023, the SEND dataset is required for anti-tumor drug reproductive to icity studies.

General Framework of SEND  Standard

Send standards describe a standard way to exchange nonclinical study data.These standards provide a consistent general framework for organizing study data,Including the following points.

l Templates for Datasets

l Standard Names for Variables

l Appropriate Controlled Terminology

l Standard Ways of Doing Calculations with Common Variables

Function of SEND

At present, the CDISC standard has been accepted by the drug regulatory departments in Europe, the United States, Japan and other countries.It is widely used in clinical research and is committed to providing data standards for the development of  medical and biopharmaceutical products.The SEND format allows for more effective review of non-clinical data.

Therefore, with the SEND data set, both the sponsor and FDA can quickly review the data to improve the data quality, accessibility, and predictability.

SEND Reference Website：

[1].SEND | CDISC https://www.cdisc.org/standards/foundational/send

[2].https://www.fda.gov/drugs/news-events-human-drugs/send-cber-what-you-need-know-12042020

●Cost advantage and time advantage: The cost of  Clindata^® for SEND Exchange is 60% lower than that of  its competitors, and the time required is 50% less. This provides innovative drug companies with significant savings in both time and money, enabling them to submit new drugs to the FDA in the quickest and most cost-effective manner.

●Industry experts and professional teams: We have specialists in SEND who will continually pay attention to and study SENDIG, TCG, and CT. We have a committed SEND declaration team, and all team members have received comprehensive training in SEND and have experience in SEND datasets transformation. On February 3, 2023, Clindata^® was awarded a soft certificate for SEND datasets exchange systems.

●Successful case: Clindata^® has assisted innovative drug companies in completing FDA pre-clinical SEND data conversion services multiple times, making us a rare local enterprise with SEND exchange capabilities in China.

●High accuracy: Clindata^® utilizes dual programming to validate the SEND datasets within the team, thereby enhancing the review's efficiency, guaranteeing accurate datasets, and expediting the approval of innovative drugs.

SEND-related Questions

？How and when does the FDA use SEND data? What does the FDA do with the SEND data?

Reply: First FDA reviews the study report along with summary tables submitted by the sponsors. The SEND data are then used by FDA to relook at any findings or to create tables for their own reviews. The SEND data are considered by FDA as an original data set which always belongs to the clients.

？Is there any case in which SEND submission is rejected even if the data are validated by software like"Pinnacle 21"? To what extent do we have to assure the quality of SEND data?

Reply: Data can pass the Pinnacle 21 validator, but that does not mean it is good data, it also takes someone to review the data to make sure it makes good scientific sense, and that data accurately reflects the study plans,  amendments, deviations, and reports.

 ？What if the initial pathology data was not recorded electronically? How are these mapped to the SEND lexicon? 

Reply: Retrospectively enter it within your pathology system. If you do not have a pathology system, it will be a lot of work to convert this data manually. One could potentially find a company who does SEND Data Conversion Services to convert the data into SEND format. There are quite a few vendors that provide this service.