Sponsors who are planning NDA submissions from 2017 can expect to include nonclinical study data in the CDISC SEND standard to comply with the FDA’s binding guidance. In preparation for this increased flow of standardized data, the FDA encourages sponsors to make test submissions of SEND data during 2015 and early 2016 so they can provide a no-risk assessment on the quality and completeness of these datasets. The recommendation is that sponsors submit at least three general toxicology and/or carcinogenicity studies of different durations and complexity over the next few months.
This is a business critical exercise that requires careful planning and execution. The inability to successfully complete a cycle of test submissions as a dress rehearsal prior to real submissions is a clear and definitive test of not being SEND ready.
Sponsors will benefit from this exercise because early identification of standardization issues can enable calibration of SEND preparation and review processes with all of their data providers. This will pave the way for a successful SEND implementation in advance of the FDA’s compliance deadlines. Test submissions have proven to be very useful to sponsors who have voluntarily submitted SDTM datasets from clinical trials, and received valuable Agency feedback. CROs also stand to gain from preparation of test datasets to demonstrate to their clients that they are SEND ready.
Please join our experts to understand the importance and urgency of performing test submissions, and for an overview of the kinds of data issues we have encountered to date.
We will also discuss options to help you prepare submission ready datasets and our subscription-based SaaS software tools that allow you to easily merge, validate and view datasets without upfront investment as you gear up for being SEND ready. Sufficient time will be set aside during this session to help answer your questions.
For more information, please contact: