We have specialized in neurodegenerative diseases and supported CNS clinical research since our inception. Today, we work with healthcare organizations around the world, across the entire clinical research journey, to deliver consultancy, drug development analytics, medical imaging operations and post-marketing surveillance.
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Drawing on our neuroscience expertise and experience, we help you optimize biomarker measurement. We provide individually tailored consultation to define best imaging endpoints and analysis methodologies to deliver requisite insights.
We ensure seamless start-up, management and delivery of your study overseen by a dedicated central point of contact. Providing highest levels of client care and support, they work with you throughout requirements gathering, documentation and stakeholder communications.
Our site management and imaging science teams work collaboratively to facilitate qualification, training and management of imaging centers, including rigorous multi-center harmonization and standardization of image acquisition protocols.
We assess image and data quality through our bespoke digital platform, TrialTracker. Automated quality checks, together with visual assessments by our expert image analysts, ensures all images and data meets project requirements.
We understand the complexities of neuroimaging in CNS clinical trials. We provide study-specific, centralized reads by world renowned neuroradiologists and rigorous image analysis by highly trained specialists.
Our scientists are at the forefront of developing the regulatory pathway for the use of imaging and digital biomarkers in CNS clinical trials. As new technologies emerge, we will work with you to validate imaging biomarkers.
With many years’ experience in supporting regulatory compliant clinical research, we are ideally placed to advise you on making informed decisions around the selection and use of imaging and digital biomarkers in CNS clinical research.
We deliver neuroimaging and digital biomarker solutions in early phase clinical development to help you maximize the ability to extract exploratory endpoints. We have extensive experience in definition and delivery of early phase development where rigorous patient safety screening runs hand-in-hand with flexibility around trial design and data analytics.
We have an established track record in delivering neuroimaging and digital biomarker solutions in global, multi-site CNS trials. We support our clients with imaging center selection, ensuring data compliance, developing enrichment strategies and responding to regulatory considerations.
Our expertise in imaging and wearable device data analytics makes us the perfect partner for the continued assessment of safety, efficacy, and optimal use once a drug is licensed. We understand the challenges of extended longitudinal studies, and the importance of monitoring patient safety and drug utilization throughout.
We’ve delivered over 100 CNS clinical trials globally, and that number continues to grow. We have now qualified over 2,000 imaging sites to deliver high quality structural and advanced MRI and PET images, processing over 100,000 scans to support imaging endpoints in CNS trials.