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

SEND Data Standardization Service

If you have non-clinical studies that needs to be standardized into SEND format, we will accept your data sources and turn them around and deliver a validated SEND data set that you can use for submissions along with the attendant Define.xml and SDRG inputs. The following options are available in increasing order of cost and complexity. A fixed price quote is provided after we have triaged the source data set at no charge. The price ranges shown below are indicative only.

Data Source AvailabilityStudy ReportIn-LifeDMPK/TK/PKHistopath/ NecropsyPrice & Turnaround Time Range
Mix of Data SourcesPDFLIMS ExtractExcel or LIMSLIMS or Excel$5K-$9K 3-4 weeks
Mix of Data SourcesPDFLIMS ExtractPDFPDF or Excel$10K-$25K 3-5 weeks
PDF OnlyPDFLIMS ExtractPDFPDF$12K-$50K 4-8 weeks
Mix of Data SourcesPDFLIMS ExtractExcel or LIMSLIMS or Excel$5K-$9K estimated 3 weeks without assurance that data matches Study Report
On-Going Studies – Interim MonitoringPDFLIMS ExtractExcel or LIMSN/A $10K for up to 3 interim reports – each delivered in 2-3 weeks or less.
Final SEND data sets with benefit of Study Report will be an additional $10K in 3 weeks

SEND Data Standardization Deliverables
  • The SEND data package delivered for each study will include the following:
  • Standardized datasets in XPT format: A zipped package containing each SEND domain populated for the study as an XPT file. These datasets will be compliant with the latest SEND Controlled Terminology and standards versions accepted by the FDA.
  • Define.XML and define.pdf files compliant with CDISC specifications.
  • Study Data Reviewer’s Guide (nSDRG): PDF document containing information regarding the study design, standardization procedures, and any discrepancies between the prepared SEND dataset and Study Report.
  • PointCross Non-clinical Validator Report: This validator checks against non-clinical CDISC SEND and FDA rules only and performs validation of both the SEND dataset and accompanying Define.xml file.
  • Pinnacle21 Validation Reports – validation report of the SEND dataset, and separately of the Define.xml file checked against the Pinnacle21 validator*


Note: PointCross uses its own validator in tandem with Pinnacle21 so users have a clear idea of what to expect in either case. We retain use of Pinnacle21 due to its familiarity within the industry.

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

If your CRO or lab provides you with a SEND data set and a Study Report in PDF then 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 10% of the qualitative data.

A fixed price quote for this service is provided after we have reviewed the SEND data set and the Study Report at no charge. The price has ranged from $5,000 for normal toxicology studies up to $20,000 for a multi-year carcinogenicity study. SEND-ASSURE services are normally competed in 1-4 weeks with longer studies with complex trial designs taking up 3-6 weeks.

SEND-Assure Deliverables

The outputs delivered for each study will comprise the following:

  • SEND-Assure report with summaries of the following:
  • Discrepancies found between the SEND datasets and Study Report
  • Discrepancies identified in the SEND datasets against the version of the SEND Implementation Guide and SEND Controlled Terminology used to standardize the data
  • Errors and warnings identified during validation using PointCross Non-clinical and Pinnacle21 validators
  • Suggestions to mediate any validation and SEND conformance issues identified by the PCLS data services team
  • PointCross Non-clinical Validator Report: This validator checks against non-clinical CDISC SEND and FDA rules only and performs validation of both the SEND dataset and accompanying Define.xml file.
  • Pinnacle21 Validation Reports – validation report of the SEND dataset, and separately of the Define.xml file checked against the Pinnacle21 validator*
    *Note: PointCross uses its own validator in tandem with Pinnacle21 so users have a clear idea of what to expect in either case. We retain use of Pinnacle21 due to its familiarity within the industry.
  • Modifications/suggestions for the nSDRG, where applicable

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

ToxVision – Non-clinical viewer
    ToxVision is a browser for review and analysis of non-clinical study data sets in SEND format. A dedicated site is set up for your company and you will administer the users who can use this Software as a Service offering. The fee schedule for this software is as follows:

  • One time set up of a dedicated ToxVision site for your company – $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 significantly more than 25 studies to be loaded please contact us for additional discounts

Follow the steps shown below to contact us and set up a contract

  • 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.