PhUSE Single day event

Beerse, Belgium
11th September 2019

Presentation Title: Review Safety Signals from Interim or Submittable SEND Datasets Using MySEND
Roche-PointCross Joint Presentation

Presentation on “Review Safety Signals from Interim or Submittable SEND Datasets Using MySEND” by Nicolas Philippe, PointCross Life Sciences and Dr. Dragomir Ivanov Draganov, Roche

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...

June 9, 2026

Categorized NON CLINICAL PointCross Blog

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,...

June 8, 2026

The Business Case for Automating Nonclinical Study Reports

Categorized NON CLINICAL PointCross Blog

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.

June 3, 2026

PhUSE Single day event

PhUSE Single day event

Mitigating risk with PointCross

5 SEND Compliance Challenges Nonclinical CROs Must Solve

The Business Case for Automating Nonclinical Study Reports

FDA SEND Requirements for Nonclinical Studies: Which Studies Need SEND Datasets in 2026?