Validating clinical trial data
Given notes many companies think implementing an RBM program may be more difficult than it actually is.
That means looking for risk indicators, since that is the more appropriate way of targeting your clinical monitoring activity to the places that need it.Medidata was selected to perform the tests because of its access to robust operational data—and one of the largest EDC data sets in the industry—aggregated in its cloud platform.Trans Celerate approached Medidata with some specific ideas, and Given notes the Medidata team helped reshape the analysis parameters based on what might be most interesting to the study. “First, we looked at the specific impact of SDV on the total number of changes made to data entered into the case-report form.This will give companies a more holistic RBM strategy that allows them to see their study risks and know where they should target their efforts.Going forward, Medidata will continue to perform additional analysis on the data.
“There are multiple sources of data, such as lab science and clinical science systems, which can create an adverse event.