The Standard for Exchange of Non-Clinical Data (SEND) is the U.S. Food and Drug Administration-required electronic data format standard for data submissions for studies related to safety pharmacology, general pharmacology, and reproductive toxicology. With years of industry experience and integrated services, and a team consisting of a number of senior industry experts as well as Ph.D. and Master's degree holders, BOC Sciences is able to meet different challenges and provide you with a helping hand in your development.
SEND Implementation Type and Time
According to the requirements of the U.S. Food and Drug Administration, starting from December 18, 2016, general toxicity tests (including single and multiple dose general toxicity tests) and carcinogenicity tests for applications for NDA, ANDA, and BLA must be submitted in accordance with the SEND format standard.
General toxicity tests (including single and multiple dose general toxicity tests) for IND applications must also adopt the SEND format.
SENDIGv3.1 includes 2 new safety pharmacology study areas, mandates NDA submission of required datasets, and includes new areas for cardiovascular and respiratory safety pharmacology studies.
SENDIGv3.1 is required for all IND submissions.
The Necessity of SEND Implementation
- Optimize data collection, delivery and storage
- Streamline data submission from sponsors to regulators
- Improving the efficiency of non-clinical/clinical studies
- Shorten the development cycle, save R&D costs, and speed up the process of bringing drugs to market
Types of Non-clinical Studies Required for SEND
| SEND 3.0 | SEND 3.1 | SEND Developmental and Reproductive Toxicology 1.1 |
| | - Developmental and Reproductive Toxicity (EFD)
|
| Single dose toxicity test | Single dose toxicity test | |
| Multiple dose toxicity test | Multiple dose toxicity test | |
| Non-GLP experiments (if used for declaration) | Non-GLP experiments (if used for declaration) | SEND 3. X |
| | -FEE |
| | -PPND |
| Cardiovascular test | -Genotoxicity test |
| Respiratory test | -Special toxicity test |
Role of SEND Implementation
- Form a drug development database through data standardization (SEND), conduct data mining and visualization as much as possible, realize the interaction of study data, conduct analytical studies of data through data standardization, use Bayesian statistical methods to improve and accelerate safety data analysis, realize data sharing, and establish a historical control database.
- Realize data visualization, allowing reviewers or researchers to directly extract styles and discover relationships between data, and realize the interaction of single study and multiple study data.
- To achieve rapid review by Food and Drug Administration, improve the quality of the review, and facilitate better communication between the regulator and the sponsor on safety aspects.
How Can BOC Sciences Help You?
To ensure the successful acceptance of your non-clinical data, we provide
- Definition documents
- Study Data Reviewer's Guide
Core Services
- We use the latest technology for data collection, management and presentation to ensure that data packages meet requirements.
- Trial summary files
- BA/TK data conversion
- Automated data delivery
- Receive your data as needed to help you make more informed decisions during your study.
What does a SEND file look like?
- Zip file (transferred via FTP or StudyTracker)
- Multiple fields (i.e. weight fields) make up a data set
- Each domain is in .xpt format
Our Advantages
- Extensive experience in doing SEND datasets.
- We use software such as DataDefine v2.1.1, Pinnacle 21, and Provantis® to ensure the correct terminology and translations are used as required, and achieve a high level of integrity.
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