In order to provide a standardized electronic dataset for your nonclinical data which will fulfill regulatory electronic common technical document (eCTD) submission requirements, a SEND dataset is required. Use of SEND enhances data review, enables data warehousing, data analysis and data visualization in addition to having a set of controlled terminology for our industry. The FDA requires a SEND dataset for non-GLP studies if those studies are part of your submission, as well as for the customary GLP studies.
An active automated check/rejection of studies that do not have study data in compliance with the requirements specified in the FDA Data Standards Catalog became effective on September 15, 2021. Attentive has the experience and utilizes industry compliant software such as Instem’s submitTM to help convert your study reports to data types presented in separate domains (e.g., body weight domain), plus other multiple domains to compile a unique SEND dataset per study for your regulatory filing.