SEND (Standard for Exchange of Nonclinical Data) describes a structured way to submit nonclinical data in a consistent format to U.S. Food and Drug Administration (FDA). SEND aims to improve the efficiency and quality of the Investigative New Drug (IND) and New Drug Application (NDA) processes.
SEND submission is now mandatory for single dose toxicity, repeat-dose toxicity, carcinogenicity, cardiovascular and respiratory studies. However, the flexible interpretation of these guidelines and resulting variability in the output datasets1 can cause delays and inefficiencies in the review process.
As an industry partner with deep expertise in IND-enabling studies, emka TECHNOLOGIES helps nonclinical scientists comply with SEND requirements by generating SEND 3.1 compatible tables directly from emka TECHNOLOGIES software.
The data can easily be exported to .xls, .csv and integrated into third-party solutions by Instem and Xybion to increase productivity in preclinical studies.
- Selection of SEND variables for each domain
- Semi-automatic population of the domains wherever possible.
- Choice lists available with the full CDISC terminology
- Management of the format codes from the implementation guide
- Preview SEND-formatted data ready to be exported as .xls or .csv files
- No need to re-validate your acquisition system. SEND export module works with any
References and additional reading
- 1 SEND harmonization & cross-study analysis: A proposal to better harvest the value from SEND data. Mark A.Carfagna et al, Regulatory Toxicology and Pharmacology Volume 111, March 2020
- Common Issues in CDISC-SEND data in FDA Toxicology Review
- Scientific Public Private Partnerships and Consortia