An article briefly describing the SEND standard
For pharmaceutical R&D personnel, the amount of data in pharmaceutical research is very large, and integrating such huge data is a very complicated task. Compared with traditional paper declarations, electronic drug declarations have many obvious advantages. For example, the SEND format can integrate data into a SEND data set, and with the addition of visualization tools, various data can be organized and analyzed on the same screen.
The Standard for the Exchange of Nonclinical Data (SEND) is a format standard for data submission required by the U.S. FDA for safety pharmacology, general toxicology, reproductive toxicology and other related studies. Traditional nonclinical data exist in multiple separate tables, and reviewers have to search through hundreds of pages of documents for the required data. Easily reading and reviewing large amounts of data files is the original intention of FDA in formulating SEND.
SEND standards are defined and maintained by the SEND team of the Clinical Data Inter-change Standards Consortium (CDISC). CDISC Clinical Data Exchange Standards Association has established a set of standards on how to collect data, what type of data to collect and how to submit the data to the agency responsible for approving new drugs, covering the entire acquisition, exchange, archiving and submission of clinical research electronic data. process. At present, the CDISC standard has been accepted by drug regulatory authorities in Europe, the United States, Japan and other countries, and is widely used in clinical research. It is committed to providing data standards for the development of medical and biopharmaceutical products. Based on preclinical data, CDISC formulated and developed the SEND standard.
In December 2014, the US FDA released Providing Regulatory Submissions in Electronic Format – Standardized Study Data (Standardized Study Data), which formally proposed the SEND standard for non-clinical data. CRO company 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, starting from December 18, 2016, applications for general toxicity tests (including single and multiple dose general toxicity tests) and carcinogenicity tests for NDA, ANDA, and BLA must be submitted in accordance with the SEND format standard;
Starting from December 18, 2017, general toxicity tests for IND applications (including single and multiple dose general toxicity tests) must also use the SEND format.
Safety pharmacology trials for NDA and BLA applications conducted after March 16, 2019, and safety pharmacology trials for IND applications conducted 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 having to reprocess the data before submitting it.
Standardization of data can ensure the effectiveness of data analysis. SEND is a set of standards for electronic data. Its function is to standardize and modularize preclinical trial data and its supporting information, and make the data more complete and logical. . The emergence of SEND is the result of joint promotion by FDA, pharmaceutical companies, FDA, CRO and other agencies. Submitting data in 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 easier said than done. It requires a deep understanding of the SEND specification to effectively produce standardized data.
