Animal Rule Studies are now accepted in SENDIG- AR v1.0 standard as of March 15th2020.
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 firstname.lastname@example.org 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||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.
“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