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We are a neuroimaging-focused CRO with a strong track record of delivering top quality results in early and late phase clinical trials across a range of diseases

Our multidisciplinary team provides the full spectrum of Imaging Core Lab services, including imaging study operations, central eligibility & safety reads, and quantitative image processing & analysis

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Imaging Study Operations

We provide end-to-end Imaging Core Lab services for small to large scale clinical trials. Our services are designed to facilitate acquisition of the highest quality imaging data.

 

Our Imaging Study Operations services include imaging site qualification, image acquisition protocol design, imaging site training, in-study site support, image transfer & reconciliation, image quality control (QC) review, study analytics (KPIs), and project management. Our Imaging Operations Management Platform is a state-of-the-art technology that allows our expert team to efficiently and effectively manage all aspects of the imaging study.

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Eligibility & Safety Reads

We have a global network of board-certified neuroradiologists and nuclear medicine physicians that can perform central eligibility and safety reads of MRI (including ARIA-E and ARIA-H), PET (including Amyloid, Tau, FDG), and SPECT (including DaTscan) scans for clinical trials using our web-based image review platform.

 

We have strong expertise in designing the image review criteria and process, as well as writing and implementing Image Review Charters. We generate read reports and closely monitor KPIs (including turnaround times) associated with the review process.

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Image Processing & Analysis

We have developed the most advanced technologies for processing and analysis of neuroimaging data in the industry. Our 21 CFR Part 11 compliant, validated software platform is purpose-built for clinical trials. Our expert team of imaging scientists and software developers leverage cutting-edge methods, including machine learning and deep learning algorithms, for robust fully-automated image processing & analysis of MRI, PET, and SPECT data.

 

Careful attention to processed image quality is paramount to the success of an imaging study and an integral part of the Biospective process. We have extensive experience with quantitative imaging biomarkers for a range of neurological diseases, including Alzheimer's disease, ALS, Parkinson's disease, Multiple System Atrophy, Multiple Sclerosis, as well as MPS and other rare, genetic diseases.

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