SEND Data Standardization Service for Nonclinical Studies
SEND Data Standardization Deliverables
- SEND Standardized datasets in XPT format in SEND 3.0 and 3.1, DART, and for Carc studies
- Define.XML and Define.PDF files compliant with CDISC specifications
- Study Data Reviewer’s Guide (nSDRG)
- Validation reports generated by PointCross’ SEND-ASSURE service.
SEND Dataset generation for Animal Rule Studies (Vaccines and Antivirals)
Animal Rule Studies are now accepted in SENDIG- AR v1.0 standard as of March 15th2020.
Contact Us for our Standard Price and Term Sheet and our Standard Service Agreement(SSA)
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Our board certified toxicologists and SEND data specialists have considerable experience with Animal Rule and Repro Tox studies. Our streamlined, automated processes for reconciliation and consistency enforcement against the study report, managed by our experienced staff, will ensure standardization of your studies to meet your time critical submissions.
Contact us at email@example.com to get a quote for your study.
This table provides indicative pricing for certain data sources. A fixed price is offered after review of source data.
For SEND data received from a CRO, our SEND-ASSURE service checks the sufficiency and reviewability of the SEND dataset and checks consistency against the Study Report. PointCross checks all the quantitative data and spot checks of the qualitative data against incidence counts.
- PointCross checks a 100% of all the qualitative and quantitative data to ensure that the SEND datasets are consistent with the study report
- Discrepancies identified in the SEND datasets against the FDA standards
- Errors and warnings identified during validation using PointCross and Pinnacle21 validators
- Suggestions to mediate any validation and SEND conformance issues identified by the PointCross data services team
- Validation reports: SEND dataset and Define file validation reports from both PointCross and Pinnacle 21 Validators
The price can range from $2,000 for small studies up to $20,000 for large studies. SEND-ASSURE services are normally competed in 1-4 weeks with longer studies with complex trial designs taking up to 3-6 weeks. We will provide firm fixed price quotes based on a specified scope of work.
eDataValidator for SEND Data validation to FDA, PMDA, and CDISC rules
The eData Validator Validates SDTM, ADaM, SEND datasets and Define.xml files destined for submission against latest FDA, PMDA and CDISC published Business, Conformance or Validator Rules. It comes with a set of reports and a QC dashboard to verify the validation outcomes and to monitor the datasets quality progression during preparation and packaging for submissions.
SRR as a Service – Study Report Reference generation in standardized templates
Study report Reference (SRR): A set of digital, machine readable, columnar tabulation files, that correctly represents of the published summaries in the Study Report is a valuable resource that can be used by a software script to compare and reconcile the summary values and incidence counts published in the Study Report with summaries re-generated from the SEND datasets.
What Our Customers Are Saying:
“We have been working exclusively with PointCross as our SEND provider since 2015. PointCross is the only SEND provider we have used, and frankly, the only provider I hope to ever use. I consider the selection of PointCross as our SEND provider to be one of my best professional decisions of my career! They have provided exceptional client service, meeting or exceeding our deadlines, answering our questions and, in short, delighting my internal team and external customers.”
– A US based CRO
“I just want to pass a thank you from both and our customer in the successful on-time delivery of the final study <##> to enable their submission of their tox package on time. From a SEND data deliverables the timelines were extremely tight but I am pleased to see how everybody pulled together to a successful conclusion. We have received very positive feedback emails from several stakeholders, all commending everybody involved in the study specifically highlighting “Your dedication, flexibility and expertise have been greatly appreciated throughout this exciting and sometimes bumpy journey” of which PointCross are also part of that service delivery. Well done and thank you for all your efforts.” – A UK based CRO