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 Availability||Study Report||In-Life||DMPK/TK/PK||Histopath/ Necropsy||Price & Turnaround Time Range
|Mix of Data Sources||LIMS Extract||Excel or LIMS||LIMS or Excel||$5K-$9K 3-4 weeks
|Mix of Data Sources||LIMS Extract||PDF or Excel||$10K-$25K 3-5 weeks|
|PDF Only||LIMS Extract||$12K-$50K 4-8 weeks|
|Mix of Data Sources||LIMS Extract||Excel or LIMS||LIMS or Excel||$5K-$9K estimated 3 weeks without assurance that data matches Study Report|
|On-Going Studies – Interim Monitoring||LIMS Extract||Excel or LIMS||N/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
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.
The outputs delivered for each study will comprise the following: