Correcting SEND Datasets for Regulatory Assurance
Our SEND ASSURE and Corrections of SEND datasets 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.
PointCross SEND ASSURE and Correction Service Benefits
When PointCross performs the SEND ASSURE service, it addresses required changes to the datasets, avoiding the logistical challenges of returning to the CRO for corrections. This approach is a cost and time saving solution for sponsors seeking quick and reliable finalization of SEND datasets.
This service also ensures that any studies outside the original scope of work with the CRO can be completed without requiring new contracts, offering added flexibility and convenience.
Optional DSR (Digital Study Report)
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.