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||LIMS||Excel or LIMS||LIMS or Excel||3-4 weeks||$5K-$9K|
|Mix of Data Sources||LIMS||PDF or Excel||3-5 weeks||$10K-$25K|
|PDF Only||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
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.
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.
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.
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.
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.
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.