Provide PointCross with your disparate data sources and have us deliver quality assured and submittable SEND datasets as a service.

This table provides indicative pricing for certain data sources. A fixed price is offered after review of source data.

Data Source AvailabilityStudy ReportIn-Life DataDMPK/TK/PKHistopath/ NecropsyTurnaround Time
Price
Mix of Data SourcesPDFLIMS Excel or LIMSLIMS or Excel3-4 weeks
$5K-$9K
Mix of Data SourcesPDFLIMS PDFPDF or Excel3-5 weeks$10K-$25K
PDF OnlyPDFPDFPDFPDF4-8 weeks$12K-$50K
On-Going Studies – Interim MonitoringNot yet AvailableLIMS Excel or LIMSN/A 2-3 weeks $10K, up to 3 interim reports

$10K, Final SEND dataset

Provide us with the SEND study dataset generated by your CROs and have us check its reviewability using our SEND-ASSURE service.

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.

 

Use our Xbiom™ Regulatory Nonclinical ToxVision™ viewer to browse your SEND data sets and review as a toxicologist

MySEND Viewer for SEND datasets

MySEND is a desktop software is a free, downloadable personal toolbox for your SEND nonclinical datasets that includes an added browser allowing you to view SEND data as tabulations, interactive graphics with charts, or through the immersive experience of advanced histopathology viewers developed in collaboration with industry leaders.
More information on MySEND: https://info.pointcrosslifesciences.com/mysend
MySEND is available for direct download through the above link, and will shortly be available on the AWS marketplace.

 

Managed Services

PointCross offers a range of business process consulting and other data management services. These may include providing consultative inputs for helping your staff become familiar with the requirements for SEND, or how to best review SEND datasets using ToxVision.
Consulting and data services are available from teams based in Silver Spring, MD, USA and Bangalore, India.

 

  • Download our Standard Price and Term Sheet and our Standard Service Agreement (SSA).

  • Send the signed SSA to   dsservices@pointcross.com
  • PointCross will reach you by mail to set up payment. If you are interested in getting in touch with a representative at PointCross, you may do so by contacting our main line at (844)382 7257.

Generation of SEND 3.1 compliant datasets

The FDA is accepting and ready to review SEND IG 3.1 coded studies. According to the Federal Register notice, the transition date for support of version 3.1 of CDISC SEND IG is March 15, 2018. Although SEND IG version 3.1 is supported as of this Federal Register notice and sponsors or applicants are encouraged to begin using it, the new version will only be required in submissions for studies that start after March 15, 2019. The catalog will list March 15, 2019, as the “date requirement begins.” When multiple versions of an FDA-supported standard are listed in the catalog, sponsors or applicants can select a version to use.”