Date: Wednesday, May 28, 2025
Time: 9:00 AM PT | 12:00 PM ET
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 Here
Questions asked during webinar:
How long does it take for you to review a SEND package when only the package and the final report is provided to you?
The SEND Assure service takes approximately 3 weeks to complete a full reconciliation and provide findings back to you; However, the timeline may vary depending on factors such as study design, duration, and complexity. An expedited service is also available upon request. For more information, please submit a request via our SEND auto quote generator, or email us at dsservices@pointcross.com
Do you correct and remedy identified errors and flags?
Our SEND Assure process has an optional addition to correct the SEND dataset, should you choose. Additional information is dependent on study type and length, though, the cost of this service is less than an entirely new SEND dataset.
Do you offer any visualization with the Assure service?
Yes, all of our deliverables include access to our flagship software, Xbiom, for use of visualization. The software is entirely web-based and can be accessed using login credentials that will be provided to you upon study upload to our secure data room.
How are the Define.xml and nSDRG reviewed? Is this automated?
Define.xml is run through the PointCross eDataValidator tool for checking conformance with CDISC and PMDA published validation rules. Additionally, it is reviewed using a define viewer for further quality checks. The nSDRG file is manually reviewed against published guidance, including but not limited to, the PHUSE published nSDRG guidelines and templates.