NeuroScios is capable of handling all safety imaging for neurological trials.
In general the most frequent neurological drug safety issues involve infarcts, haemorrhages, ARIA-H (micro-haemorrhages), ARIA-E (Vasogenic Edema), or issues with the BBB.
Safety imaging takes place at certain predefined timepoints during the trial, as several of the occurring AE’s will show limited (or no clinical significant signs at all) during physical examination. Early detection by Imaging prevents that a condition suddenly appears as a late finding at clinical tests with the risk of permanent damage. Early discovery by Imaging and a timely dose-stop can possibly prevent that trial subjects are dosed while actually having a serious adverse event.
NeuroScios has several experts that will make sure that the “Imaging” paragraph on a clinical trial protocol will follow regulatory guidance.
In addition to consultancy NeuroScios can also support a trial with giving guidance to local Radiologists about the set-up and review of neuroscience imaging.
As a complete service, NeuroScios offers to handle Central Reading of clinical trial neuroscience imaging, with reports to sites and/or safety committees.