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PointCross supports over 25% of all SEND datasets submitted to the FDA since 2016.
Trusted by leading sponsors. 100% submission guarantee & unmatched delivery speed.

SEND Dataset Generation & QC
 

Fast, Accurate, and Submission-Ready SEND Data Solutions.
100% Traceability, Industry-Leading Turnaround & Price, Total Peace of Mind.

8,500+

Studies Standardized
since 2012

24 Hours

Firm Quote Turnaround

100%

Accuracy & Submission Guarantee

40%

Avg. Client Cost Savings

What We Offer

  • Generation of SEND datasets 100% consistent with Study Reports, including custom domains like ADA.

  • Accurate Trial Design regeneration and Digital Study Report (DSR).

  • Turnkey delivery: Submittable SEND datasets with Define.xml and nSDRG.

  • Business-level reconciliation - SEND data checked and errors corrected before delivery.

  • Visualization and analytics via Xbiom™.

  • FDA & global submission-ready datasets, with no rejection guarantee.

Generate Instant SEND Quote

How It Works

1. NDA &
Document Upload

2. Expert Review &
Analysis

3. Firm-Fixed
Instant Quote

4. Secure Delivery &
Support

Our Deliverables

​SEND Data Standardization
SEND-Like Standardization (Legacy Studies)

​​

  • SEND Package (xpt files, nSDRG, Define.xml, define.pdf)

  • 100% check vs. Study Report

  • Conformance via eDataValidator

  • DSOAR Report (if needed)

  • Xbiom™ access for 30 days

  • 90 days warranty

​​

  • SEND-like dataset (xpt files)

  • 100% checked vs. Study Report

  • eDataValidator conformance

  • DSOAR Report

  • Xbiom™ access for 30 days

  • 2 weeks warranty

Quality, Consistency & Regulatory Compliance

  • Consistency: 100% checked, with full Consolidated Reports.

  • Conformance: Validator reports for CDISC, FDA, PMDA rules.

  • nSDRG: PhUSE-compliant Reviewer’s Guide.

  • Define.xml & PDF: Machine & human-readable docs.

  • DSOAR: Optional Excel analysis beyond nSDRG.

  • Digital Study Report (DSR): Reviewed in Xbiom™.

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