Overview
Standard for Exchange of Non-clinical Data (SEND) Services
SEND services are essential for pharmaceutical and biotechnology companies conducting nonclinical studies to comply with regulatory requirements for data submission and facilitate the review process by regulatory agencies. By standardizing and harmonizing nonclinical data, SEND aims to improve data quality, interoperability, and transparency in drug development and regulatory decision-making.
SEND is a data format developed by the Clinical Data Interchange Standards Consortium (CDISC) for the electronic submission of nonclinical study data to regulatory authorities. SEND is based on the CDISC Study Data Tabulation Model (SDTM), which provides a standardized way of organizing and representing nonclinical data.
Services
Our SEND services include:
- Data conversion: We can convert your nonclinical study data into SEND format, using our proprietary software and expertise.
- Data validation: We can validate your SEND data to ensure that it meets the CDISC standards.
- SEND package creation: We can create complete SEND packages, including all of the required datasets, controlled terminology, and metadata.
- Regulatory submissions: We can help you to submit your SEND packages to regulatory authorities, such as the US Food and Drug Administration (FDA).
Benefits
Our SEND services can help you to:
- Improve the efficiency and accuracy of your regulatory submissions
- Reduce the time and cost required to bring new products to market
- Ensure that your data is compliant with CDISC standards
- Facilitate data sharing and collaboration with external partners