The U.S. Food and Drug Administration (FDA) requires SEND as a standard for data submission. FDA SEND dataset service is offered by PointCross that delivers submittable SEND datasets with Define.xml and nSDRG at industry’s most competitive rate. PointCross provides a suite for the creation and management of FDA ready SEND Datasets.
Data Standards
SEND is evolving and growing of suggestions from sponsors and other stakeholders. By accepting the SDTM and ADaM for clinical data and the SEND standard for non-clinical data, FDA continues to implement data standards for study data. The FDA specified that all studies starting on or after December 17, 2016 must apply the data standards mentioned in the FDA Data Standards Catalog, otherwise the application may receive a refuse-to-file action.
Why use PointCross FDA approved SEND dataset service?
- Assurance of quality and complete compliance with the GLP Study Report
- Lowest price in the sector, quick delivery, and option for faster processing
- SEND can regenerate all published summary tables in the Study Report thanks to digital reconciliation.
- On Xbiom, SEND datasets may be viewed and further examined, including for cross-study analysis and comparison in a searchable, indexed repository.
- In Study Report terminology (DSR) and SEND-IG CT, digitized data is available.
- SEND dataset, Define.xml, and nSDRG comply with TCG requirements, reducing the chance of programme rejection or delay.
To ensure correctness and consistency between the SEND dataset and the Digital Study Report, the final SEND dataset is reconciled against it Digital Study Report (DSR). Both SEND or subject data are checked until the issue is resolved if cannot re-generate the published summary tables for the sponsor defined groupings.