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.
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.
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.”
With FDA set to review SEND 3.1 datasets, think about your strategy for how to deal with studies that have been coded for SEND 3.0 but are slated for submission only after the 2019 or 2020 dates. We have developed tools that can help convert your data retrospectively. Provide your SEND 3.0 datasets across to us and we can convert these into SEND 3.1 datasets through our Data Standardization services.