Date: Wednesday, May 28, 2025
Time: 9:00 AM PT | 12:00 PM ET
Location: Online (Live Zoom Webinar)
Most SEND preparers (CROs, Vendors, In-house) perform spot-checks, visual QC, or checklist based compliance to ensure their SEND datasets are submission ready and compliant with the FDA's Technical Conformance Guide and Technical Rejection Criteria.
Learn how PointCross uses automation, reconciliation checks, and 100% traceability to the Study Report as a three-part measure to ensure all submission artifacts are accepted by FDA CDER and CBER for digital analysis and review.
📦 What Is SEND Assure?
A turnkey QC solution for verifying and validating SEND datasets (including Define.xml and nSDRG) against:
- The final Study Report and metadata
- CDISC and SEND IG best practices
- FDA & PMDA conformance rules using PointCross’ eDataValidator
Learn more about SEND ASSURE