Our head of SEND Services and Chief Toxicologist at PointCross Life Sciences collaborated on a whitepaper on how to assess your SEND readiness. To access the full document, please click here. We have also summarized the document below.
When we check nonclinical studies in SEND format with our SEND-ASSURE service, we find that there are significant inconsistencies between the SEND data sets and the data reported in the Study Report. The overall quality of the SEND data set is classified in terms of:
- Conformance to standards and business rules
- Consistency with the audited Study Report in PDF, and
- Quality of SEND data packaging, Trial Summary, Define.xml, and nSDRG
Across a dozen studies we found that SEND conformance did not meet the requirements for data being correct and consistent with the Study Report – which is the only audited data in a study’s submission. We have found that no studies are completely consistent. This chart shows the average number of substantial inconsistencies across these dozen studies. Read more about what this means in terms of SEND Readiness and what can be done to ensure that your studies are ready to be submitted.