CDISC SEND Compliant Data for FDA Submission
The CDISC Standard for the Exchange of NonClinical Data (SEND) provides a framework for submitting animal data in a common format and structure that the FDA and other Health Authorities can use, making the review process more efficient and cost-effective.
The FDA mandated the use of the CDISC SEND format for any animal studies that started after December 17, 2017.
Many R&D teams preparing for their first IND may not fully understand the requirements and nuances of submitting data in the CDISC SEND format. Creating CDISC SEND compliant submission deliverables takes time and expertise and should be included in early planning discussions for an IND.
This case study illustrates TradeCraft's expertise and practical experience creating compliant submission deliverables. Our vast experience with submission data packages enables us to produce each component quickly, efficiently, and in compliance with the relevant data standards.
Many CROs produce “CDISC-like” output. They typically don’t inform clients of the FDA’s specific requirements and then charge additional fees to rework the data to align with the CDISC SEND format and structure. If your team is preparing for an IND, check out the case study and contact us to arrange a time to discuss your submission and how we can help you submit quality, compliant data deliverables in the most efficient manner. It’s what we do every day!