Correcting SEND Datasets for Regulatory Assurance
Our SEND ASSURE and Corrections service ensures 100% assurance of submission acceptance by regulatory authorities or seamless use in repositories, eliminating uncertainties about third-party corrections.
These corrected datasets are updated with the latest SEND standards, including Controlled Terminologies and Implementation Guides, ensuring compliance and accuracy.
Compliance Guarantee
We update your datasets to match the latest CDISC and FDA standards, removing the risk of technical rejection.
Service Benefits
Why sponsors choose PointCross for dataset remediation and correction.
Avoid CRO Logistics
Address required changes immediately without the logistical challenges of returning to the CRO.
Cost & Time Savings
A streamlined solution for sponsors seeking quick and reliable finalization of SEND datasets.
Flexible Scope
Complete studies outside original CRO scope without requiring new contracts.
Digital Study Report (DSR)
For those seeking additional value, PointCross offers an optional Digital Study Report (DSR). The DSR presents the study in its original format and terminology, providing familiarity for Study Directors and Sponsor Toxicologists.
Add DSR to PackageWhy Add DSR?
- ✓ View study in familiar terminology
- ✓ Original format presentation
- ✓ Enhanced validation capability
