Clinical Trial Services

 

The Buffalo Neuroimaging Analysis Center (BNAC) is a dedicated research center for qualitative and quantitative analysis of magnetic resonance imaging (MRI), positron emission tomography (PET), computerized tomography (CT), and magnetic resonance and digital subtraction angiography for clinical research including conduct of Preclinical and Clinical Phase I, II, III, and IV trials and investigator-led research studies on multiple sclerosis (MS) and other neurodegenerative diseases. 

BNAC ensures fast contracting, ethical committee approval and start-up processes, and is structured to manage multiple projects with tens of thousands of scans. 

BNAC brings to every clinical trial a high degree of professionalism and integrity that stipulates unequivocal respect for deadlines and commitments. BNAC has been involved in more than 60 clinical trials in multiple sclerosis, stroke and Parkinson’s disease, and has experience collaborating with over 420 centers around the world, located on five continents in more than 55 countries, including:

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Macedonia, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sudan, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States.

BNAC has calculated qualitative and quantitative imaging metrics on over 15,000 subjects and 50,000 MRI, PET, CT, magnetic resonance and digital subtraction angiography and other imaging modality exams. BNAC served as a centralized imaging center in 8 phase III regulatory clinical trials, of which 5 have been already approved by Food and Drug Administration (FDA).

 

 

Clinical Trial Staff

BNAC represents a multidisciplinary organization that includes a staff with varied scientific, educational, and ethnic backgrounds.

Our team consists of 50 academic and clinical experts, including board-certified, fellowship-trained physicians and key opinion leaders (KOLs) with sub-specialization in neurology therapeutic areas and indications. In addition to Dr. Robert Zivadinov, the Director of BNAC, senior staff includes the Directors of IT, Neuroinformatics Development, Integration, MRI Sequence Development and Preclinical Units.

 

Clinical Trial Services

Our team provides top-quality service by combining years of experience with state-of-the art and innovative technology. In chronic neurological diseases with a high degree of longitudinal variability in clinical signs and symptoms within and between patients, there are at present no adequate biological markers of disease progression. Thus, quantitative imaging techniques serve as powerful instruments for non-invasive evaluation.  Different qualitative and quantitative imaging markers are tracked (i.e., assessed upon diagnosis and monitored over time) to determine any changes. Since its inception, BNAC research projects have involved many collaborations with clinicians, scientists, and pharmaceutical industries pursuing the use of qualitative and quantitative imaging to study brain disorders.

Our services are tailored to meet the requirements of each clinical trial and the needs of the study sponsor. 

 

 

Trial Design Assistance

BNAC provides assistance for design/development of multi-center clinical trial protocols that involve qualitative and quantitative imaging analysis in research studies on multiple sclerosis and other neurodegenerative diseases. The services include design of the clinical and imaging part of the protocol and writing of the protocol.

 

Personnel Training

BNAC establishes trial-specific teams that are responsible for the organization, conduct and oversight of the imaging component of clinical trials, from study start-up through production of the final database. Study-specific training for BNAC team members includes participation in site visits, technical start-up meetings and investigator meetings. Additionally, BNAC develops web-based training sessions for efficient training of study coordinators and imaging staff at multiple sites. 

 

Protocol and Technologist Manual Development

Achieving consistent quality images across vendors and field strength is critically important in multi-center studies. BNAC serves as a consultant center to sponsors in the development of imaging protocols based on pre-determined objectives of the trial. The BNAC’s on-staff physicists work to ensure that the highest quality images are collected, given the options available at each site participating in the study. Based on scanning requirements, BNAC will develop a specialized Technologist Manual that provides comprehensive, step-by-step instructions on the entire imaging process. BNAC’s experience with all major imaging vendors and thorough dummy run procedures ensures that comparable quality images will be collected at each site.

 

Trial Operations

 

Post-trial services

 

Contact Us Today

If you are interested in clinical trial services from the Buffalo Neuroimaging Analysis Center, please contact us today by filling out a form or calling our office . We look forward to discussing the ways our team can assist with completing a successful clinical trial.