Neuroimaging, with its ability to visualize extraordinary information about the structural, functional and biochemical characteristics of the human brain, is a powerful tool in CNS clinical research.
As well as providing key biomarker endpoints to measure therapeutic effects, neuroimaging allows drug development sponsors to gain critical efficiencies by maximizing the statistical power of trial sample sizes.
Due to the complexities of therapy-specific biomarker selection, patient recruitment, analysis methodologies and multi-center logistics, it is challenging for sponsors to translate the real value of neuroimaging into successful operationalization and trial outcomes.
With our specialist neuroscience knowledge, AI-driven innovation and robust operational infrastructure, IXICO solutions are specifically designed to enable sponsors to address these challenges and realize the full power of imaging biomarkers in their CNS clinical trials.
We have extensive experience in definition and delivery of early-phase clinical development (Phase I & II clinical trials). Our rigorous patient safety screening and operational practices go hand-in-hand with our ability to be flexible around your trial design and data analytics requirements.
We have a global network of over 2,000 imaging centers and an established track record in delivering neuroimaging and digital biomarker solutions in global, Phase III clinical trials. Our proprietary TrialTracker platform ensures large-scale studies can be set up quickly and efficiently, delivering quality data which is as reliable as it is regulatory compliant.
Our expertise in data analytics makes us the perfect partner for continued assessment once a drug is licensed. We understand the challenges of extended longitudinal clinical studies, and the importance of monitoring patient safety and drug utilization for ongoing optimization of patient pathways.
With many years’ experience in supporting regulatory-compliant CNS clinical research, we work with clients on the selection and use of medical imaging and digital biomarkers. We can do this directly with your own teams or as members of collaborative consortia.