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.
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