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A brief description of the SEND standard

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For pharmaceutical R&D personnel, the amount of data in pharmaceutical research is very large. Integrating such a large amount of data is a very complicated task. Compared with traditional paper declaration, electronic drug declaration has many obvious advantages. For example, the SEND format can integrate data into a SEND data set, and visual tools can be used to organize and analyze various data on the same screen.

The Standard for the Exchange of Non-Clinical Data (SEND) is a format standard for the submission of data for safety pharmacology, general toxicology, and reproductive toxicology required by the US FDA. Traditional non-clinical data exists in the form of multiple independent tables, and reviewers have to search for the required data in hundreds of pages of documents. Easily read and review a large number of data files is the original intention of the FDA to formulate SEND.

The SEND standard is defined and maintained by the SEND team of the Clinical Data Inter-change Standards Consortium (CDISC). The CDISC Clinical Data Exchange Standards Association has established a set of standards on how to collect data, what type of data is collected, and how to submit the data to the agency responsible for approving new drugs. It involves the acquisition, exchange, archiving, and submission of clinical research electronic data. process. At present, the CDISC standard has been accepted by the European, American, Japanese and other drug regulatory authorities, and is widely used in clinical research, and is committed to providing data standards for the development of medical and biopharmaceutical products. In response to pre-clinical data, CDISC developed the SEND standard.

In December 2014, the US FDA issued Providing Regulatory Submissions in Electronic Format-Standardized Study Data (Electronic format submission of regulatory application-standardized test data), this document officially proposed the SEND standard for non-clinical data. CRO Medicilon is equipped with Submit software and has its own port. It can independently complete toxicological research data in SEND format for FDA application projects to ensure that clinical research applications meet FDA requirements.

According to the requirements of the US FDA, from December 18, 2016, applications for NDA, ANDA, and BLA general toxicity tests (including single and multiple administration general toxicity tests) and carcinogenicity tests must be submitted in accordance with the SEND format standard;

Starting from December 18, 2017, the general toxicity test (including single and multiple-dose general toxicity test) applying for IND must also adopt the SEND format.

The safety pharmacological test for NDA and BLA applied after March 16, 2019 and the safety pharmacological test applied for IND after March 16, 2020 are also required to be submitted to the FDA in SEND format. If the above requirements are not followed, the sponsor’s application may face the risk of being rejected or reprocessing the data before submitting it.

Standardization of data, standardization can ensure the effectiveness of data analysis. SEND is a set of electronic data standardization. Its role is to standardize and modularize pre-clinical trial data and its supporting information, and make the data more complete and logical. . The emergence of SEND is the result of the joint promotion of FDA, pharmaceutical companies, FDA, CRO and other institutions. Submitting data in the SEND format brings convenience to all parties, and has the advantages of high efficiency, easy data analysis, easy storage and easy data integration. However, SEND is easy to know and difficult to do, and it is necessary to deeply understand the SEND specification in order to effectively produce the specification data.

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