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

SEND Data Standardization Service for Nonclinical Studies

 

SEND Data Standardization Deliverables
  • SEND Standardized datasets in XPT format
  • Define.XML and Define.PDF files compliant with CDISC specifications
  • Study Data Reviewer’s Guide (nSDRG)
  • Validation reports generated by PointCross’ SEND-ASSURE 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.

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

ToxVision – Nonclinical viewer
    We provide clients of our Data Standardization or SEND-ASSURE service with a free downloadable validator and SEND data browser. For advanced review capabilities clients may subscribe to ToxVision™, a SaaS (Software as a Service solution) for review and analysis of nonclinical study datasets in SEND format. The fee schedule for this software is as follows:

  • One time set up of a dedicated ToxVision site – $10,000
  • Includes one online training session for users, and one training session for system administrators
  • Additional training sessions are charged at $250/session
  • Price per study loaded – $250/Study/Month with a minimum commitment of $3,000 per year
  • If you anticipate more than 25 studies to be loaded please contact us

Professional 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 d…@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 OR our Data Standardization team at (301) 755 0460.