Send-Services

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.

END 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)

Email Us :
dsservices@pointcross.com

Call us Toll Free : (U.S.)
+1 844-382-7257

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 dsservices@pointcross.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.

Data Source Availability Study Report In-Life Data DMPK/TK/PK Histopath/ Necropsy Turnaround Time Price
Mix of Data Sources PDF LIMS Excel or LIMS LIMS or Excel 3-4 weeks $5K-$9K
Mix of Data Sources PDF LIMS PDF PDF or Excel 3-5 weeks $10K-$25K
PDF Only PDF PDF PDF PDF 4-8 weeks $12K-$50K
On-Going Studies – Interim Monitoring Not yet Available LIMS Excel or LIMS N/A 2-3 weeks $10K, up to 3 interim reports

$10K, Final SEND dataset

SEND-ASSURE Service

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.

 

SEND-ASSURE Deliverables

  • Discrepancies found between the SEND datasets and 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