SEND Dataset Preparation
PointCross generates SEND datasets that are 100% consistent with (and traceable to) the Study Report, including for data that may currently require custom domains, such as ADA. PointCross accurately regenerates the Trial Design and creates a Digital Study Report (DSR) to extract all essential metadata and summary tabulations for use in precisely populating SEND domains with LIMS subject data and study metadata.
This turnkey service delivers submittable SEND datasets with Define.xml and nSDRG at industry’s most competitive rate and fastest turnaround time.
The resulting SEND dataset is reconciled against the Digital Study Report to ensure accuracy and consistency between the SEND data and the Digital Study Report (DSR). If SEND or subject data is unable to re-generate the published summary tables for the sponsor defined groups, both are checked until the error is corrected.
Business Benefits
- Assured quality and 100% consistency with the GLP Study Report
- Lowest cost in the industry
- Rapid delivery timeline with expedited processing available
- Digital reconciliation ensures that SEND can regenerate all published summary tables in the Study Report
- SEND datasets can be visualized and further analyzed on Xbiom™ including for cross-study analysis and comparison in an indexed and searchable repository
- Digitized data is available in Study Report terminology (DSR) and in SEND-IG CT
- SEND dataset, Define.xml and nSDRG meet TCG rules and 100% no rejection guarantee based on technical rejection criteria
Generate an automatic, no-obligation, and instant SEND generation quote here.
SEND Data Standardization Deliverables
| Service | Deliverables |
| SEND Data Standardization Deliverables | SEND Package (xpts, nSDRG, Define.xml, define.pdf) |
| Consistency:Consolidated Quantitative and Qualitative Comparison Report on 100% Reconciliation against Study Report | |
| Conformance: eDataValidator against all applicable rules. Optional cross-compare with P21 validator | |
| DSOAR Report, if needed, to correct source data or Study Report | |
| Access to SEND data on Xbiom for view, analysis for 30 days | |
| 90 days warranty remedies for reported issues |
SEND Data Standardization Deliverables
- Submission Ready SEND dataset(s)
- Documentation of Consistency, Conformance and Quality Checks
- Consolidated Quantitative and Qualitative Comparison Report: 100% Consistency Checked Against Study Report for all SEND domains: Unresolved reconciliations entered into nSDRG
- Conformance Validator: PointCross eDataValidator Report against applicable CDISC Conformance Rules, FDA Business rules for SEND, and PMDA/CDISC Define.xml. Extended PointCross Quality Rules validated and reported. Comparative report with Pinnacle 21 Community Validator available on request.
- nSDRG (Nonclinical Study Data Reviewer’s Guide): PDF of PhUSE template with annotations explaining standardization decisions relating to Study Design, Study Report following published expectations of FDA Reviewers.
- xml: Machine-readable XML and human readable PDF of metadata that describes SEND SDTM tabular dataset structure to inform regulatory reviewers which datasets, variables, controlled terms, and other specified metadata were used in the submitted study.
- Only if-needed – DSOAR (Data Standardization, Observations and Assumptions Report): An optional -Excel report generated for benefit of client or sponsors to inform them of any actionable suggestions and observations about the source data or the Study Report that are beyond the explanations that can be entered into the nSDRG.
- The DSR is available to customers who want the study in its original form and terminology for analysis and comparison to the Study Report, as the Study Director and Sponsor Toxicologists are used to seeing. The DSR is made available in Xbiom in a universally standardized control terminology for cross-study analysis or output to a SEND dataset with the selected SEND IG and CT, and is thus available for regulatory submissions with validation against all applicable conformance rules using the eDataValidator.
Delivered SEND datasets will be available, in a dedicated instance of Xbiom™, for acceptance of the delivery, or for private use by viewing, reviewing and analyzing the delivered Study Data in SEND for a period of 30 days after delivery of the SEND dataset. PointCross warrants the workmanship of the delivered items for 2 weeks after delivery to remedy any reported issues or defects.
SEND-Like Standardization Deliverables of Legacy Studies for Repositories
| Service | Deliverables |
|
SEND-Like Standardization Deliverables of Legacy Studies for Repositories |
SEND dataset(xpt files) for use in Analysis or Repositories |
| Consistency: 100% checked against Study Report | |
| Conformance: eDataValidator | |
| DSOAR Report, to correct source data or Study Report | |
| Access to SEND data on Xbiom for view, analysis for 30 days | |
| 2 week warranty remedies for reported issues |
SEND-Like Standardization Deliverables of Legacy Studies for Repositories
- SEND dataset(s) for use in Analysis or Repositories
- Documentation of Consistency, Conformance and Quality Checks
- 100% Consistency Checked Against Study Report for all SEND domains
- Conformance Validator: PointCross eDataValidator Report against applicable CDISC Conformance Rules and PointCross Quality rules for ensuring analysis readiness
- DSOAR (Data Standardization, Observations and Assumptions Report): An Excel report generated for benefit of client or sponsors to inform them of any actionable suggestions and observations about the source data or the Study Report that affect generation of SEND-Like digitized tabulation data.
Delivered SEND datasets will be available, in a dedicated instance of Xbiom™, for acceptance of the delivery, or for private use by viewing, reviewing and analyzing the delivered Study Data in SEND for a period of 30 days after delivery of the SEND dataset. PointCross warrants the workmanship of the delivered items for 2 weeks after delivery to remedy any reported issues or defects.