IND and NDA submissions to the FDA now require SEND (Standard for Exchange of Nonclinical Data) 3.1 datasets for preclinical studies. Both Sponsors and CROs experience challenges in creating the datasets in the correct format and accurately reflecting the final study report. Xybion has services to solve these challenges for you.
Gain Industry Expert insight and actionable solutions in this FREE WEBINAR:
- Current SEND FDA expectations
- Key challenges in implementing SEND submission processes
- Xybion’s services for conversion, verification and corrections
- Leveraging SEND data beyond submissions
Join Bob Friedman, Chief Technologist, Xybion on August 04 at 11.00AM EST to understand how Xybion can convert your datasets, verify your datasets and correct them to make sure that your submissions are not held up through the review process.