Bio-IT World Conference an Expo – 2019
Drop by our booth #638. We will be showcasing our Xbiom solution and offering demos on site and on request of our solution at the booth
April 15-18, 2019
Related Posts
Mitigating risk with PointCross
As some may have heard, the FDA released their bi-annual update to the Technical Conformance Guide earlier this year. Along with slight corrections and improvements, an entire Appendix was added regarding SEND data review "Best Practices". With the update, the...
5 SEND Compliance Challenges Nonclinical CROs Must Solve
This article breaks down the real SEND compliance challenges that nonclinical CROs face, grounded in current FDA and CDISC requirements, and shows where disciplined process and the right tooling change the outcome. We write this for toxicologists, regulatory affairs professionals,...
The Business Case for Automating Nonclinical Study Reports
The study report and its SEND dataset are built twice from the same data. Automating nonclinical study reports deletes that duplication, cuts cost 30 to 50 percent, and removes the inconsistencies that trigger FDA queries.
FDA SEND Requirements for Nonclinical Studies: Which Studies Need SEND Datasets in 2026?
Complete FDA SEND guide: which nonclinical studies require SEND datasets, SENDIG 3.1.1, DART, AR, Genetox deadlines, GLP rules, and IND/NDA scope explained.
