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Neuroscience

Comprehensive Neuroscience Services

Bioclinica delivers therapeutic expertise, regulatory leadership, and global operations to expedite neuroscience clinical trials with imaging endpoints. We have more experience in the design and conduct of neuroscience clinical trials than any other core lab, highlighted by our support of the majority of Phase III Alzheimer's Disease clinical trials incorporating imaging endpoints.

Bioclinica is the world leader in centralized imaging services, providing sponsors with comprehensive support for clinical trials across all major neuroscience indications. We understand the complexities of imaging endpoints required for monitoring specific disease states.

  •   World class Neuroscience expertise

  •   Centralized image analysis

  •   Study design and protocol development

  •   Global site selection and authorization

  •   ECG and Ambulatory Blood Pressure Monitoring (ABPM)

  •   Biomarker selection and analysis

Therapeutic Strengths

Bioclinica is the world leader in centralized imaging services, providing sponsors with comprehensive support for clinical trials across all major neuroscience indications. We understand the complexities of imaging endpoints required for monitoring specific disease states.

Areas of Focus

  • Alzheimer's Disease (AD) and other dementias
  • Multiple Sclerosis (MS)
  • Stroke
  • Parkinson's disease (PD)

Additional Indications

  • Down Syndrome
  • Intracranial Hemorrhage
  • Mild Cognitive Impairment
  • Progressive Supranuclear Palsy
  • Psychiatric Disorders
  • Spinal cord Injury
  • Trauma

LEVERAGE OUR NEUROSCIENCE EXPERTISE

Contact us for more information or to speak with us about how we can support your next trial.

CONTACT US Overview Sheet

Bioclinica's application of SMART in Neuroscience

Bioclinica advances clinical trials via SMART — a robust suite of centralized medical imaging services designed to manage the complex imaging process from image receipt to analysis, to regulatory submission.

Advanced medical imaging can provide important, quantitative information on global and regional structural changes in the brain, informing patient eligibility and drug efficacy. Molecular imaging and functional MRI provide increasingly vital information about brain function, enabling sophisticated evaluation of disease states. Our neuroscience team has experience with the latest advancements in biomarkers.

  • Structural MRI
  • Functional MRI (fMRI)
  • Computed Tomography (CT)
  • Molecular Imaging (PET/SPECT)
  • Angiography
  • ECG and ABPM
  • Optical Coherence Tomography (OCT)

Images are electronically uploaded from trial sites, blinded and rigorously quality checked. Bioclinica employs a “Multi-Step Quality Control” process that ensures the image data received from the sites will be of the highest quality. Our process enables thorough and precise image data management and analysis. We accept DICOM or manufacturer-specific formats.

We maximize your subjects' image data to help achieve the statistical power of your study. The end result is quality measurement data — delivered on time and within budget.

We track all patients enrolled in studies and all imaging data generated during the course of a clinical trial. Our expert technicians use innovative tools to deeply review, update, and assure compliance with clinical trial protocols and defined reading paradigms. This enables queries to be issued, tracked, and resolved. Our ICL collection management process is designed to detect early on any substandard image quality or violations of the imaging protocol.

Our imaging core lab collection management process includes:

  • Collect image data
  • Query sites for missing data
  • Translate/digitize image data
  • Image QA/QC
  • Image data query resolution
  • Archive for long-term storage
  • And more

Expert Independent Review

Advanced neuroimaging provides sensitive, quantitative and longitudinal information on global and regional structural changes in the brain, informing patient eligibility and drug efficacy of new treatments in clinical trials. Beyond structural data, Molecular imaging (PET) and functional MRI provide clinicians with increasingly sensitive information about brain function, enabling sophisticated evaluation of disease state modifications.

Our neuroscience team has experience with the latest advancements in molecular neuroimaging and biomarkers. Through collaborations with scientists at leading universities, government agencies, and research foundations, Bioclinica continually innovates and develops standardized neuroimaging methodologies for evaluating investigational therapies.

  • Angiography

  • ASL-perfusion

  • CT

  • CT angiography (CTA)

  • Diffusion Tensor Imaging (DTI)

  • Diffusion Weighted Imaging (DWI)

  • Dopamine Transporter (DaT)

  • Florbetapir (Amyvid) PET

  • Fluorodeoxyglucose (FDG) PET

  • Flutemetamol (Vizamyl) PET

  • Functional MRI (fMRI)

  • Magnetic Resonance Angiography (MRA)

  • Magnetization Transfer (MTR)

  • Perfusion Weighted Imaging (PWI)

  • Pittsburgh compound (11C-PiB) PET

  • SPECT (DaTscan, In-111 labeled tracers)

  • Susceptibility Weighted Imaging (SWI)

  • Volumetric MRI

High Quality Data

Bioclinica takes careful measures to ensure that the data you receive is of the highest quality and meets regulatory compliance. Initial site authorization and ongoing image quality control impact the overall quality of data emerging from a trial. We maintain close interactions with clinical and imaging sites, helping sponsors identify quality findings, resolve image queries, and adhere to protocol workflow and timelines.

  • Rigorous site authorization and training

  • Image QC

  • Independent eligibility and safety assessments

  • Robust quantitative analysis

  • Validated, regulatory compliant software

Scientific Expertise

Neuroscience clinical trials rely on the accurate collection of high quality image data for complex endpoints. Bioclinica's renowned neuroscience team delivers specialized expertise in support of your trial, from protocol design through regulatory submission.

  • Expert Neuroradiologists

  • Dedicated Image Processing Scientists

  • PET specialists

  • MRI Physicists

Our deep understanding of neuroimaging allows us to assign the most appropriate scientific experts to your study. Under the leadership of Joyce Suhy, PhD, Bioclinica provides extensive knowledge and Neuroscience experience to the design, implementation and conduct of your trial.

Scientific Team

Click on a name below to learn more about the members of our Neuroscience team.

 

With Bioclinica, you'll receive powerful, comprehensive reporting services for sites and sponsors, which supports the management and review of data for clinical trials.

Gain access to real-time reports, such as:

  • Metrics reports

  • Project status reports

  • Custom client reports

  • Analysis results reports

  • Safety and eligibility reports

  • Billing reports

Bioclinica's transfer tools support a wide range of formats to meet client and project specifications — tools that enable clinical trial data delivery, including patient data and imaging data, to sponsors, external vendors, and partners.

LEARN MORE ABOUT THE SMART PROCESS

DOWNLOAD INFOGRAPHIC

ADDITIONAL RESOURCES

Medical Imaging Services for Clinical Trials

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Comprehensive Neuroscience Services

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Alzheimer's Disease Capabilities

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Multiple Sclerosis Capabilities

Download OVERVIEW SHEET

Stroke Capabilities

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Parkinson's Disease Capabilities

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Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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