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

 

Dummy Run Scan Assistance Program 

BNAC works with each site to ensure the best quality images are produced that are within the parameters required for the study. We have developed a special “Dummy Run Scan Assistance Program” to assist each imaging center in the collection, transmission, communication, and archiving procedures as related to the imaging component of Phase I, II, III, and IV trials. All participating trial sites are required to submit “dummy run” imaging scans to BNAC. This training program includes the development and distribution of specialized, study-specific Technologist Manuals, the organization and conduct of pre-dummy run teleconferences with key site team members, offline and online training, providing detailed instructions for imaging collection, and performing all quantitative analyses as defined in the BNAC-sponsor developed scope of work. Within 48-72 hours of receipt of the dummy run exam, BNAC provides sites with exam evaluation, Site Certification to enroll subjects, and scanner-specific parameters to guide the collection of all study imaging exams. We believe that our “Dummy Run Scan Assistance Program” is one of the most advanced of its kind in clinical trials.

 

Clinical Trial Call Center 

BNAC is dedicated to answering questions from sites as quickly as possible. To this end, BNAC has created a “Call Center” so that sites have an additional method of contact with BNAC team members. In order to account for global time zone differences, the call center is operational 18 hours per day Monday-Friday. Our physicists and team are available to answer study or protocol questions as they arise. If necessary, and on a case-by-case basis, BNAC’s physicist will visit sites that need additional assistance in optimizing the scanning protocols (7 days from the day of request in the USA and 15 days from the day of request in Europe). BNAC supports verbal language assistance in English, Italian, German, Dutch, Bulgarian, Croatian-Serbian, Russian, Hindu, among others.

 

Scan Acceptance Assistance Program 

BNAC has a 48-hour standard turnaround time for lesion identification, adherence to image parameters as determined in dummy run process, visual inspection for imaging artifacts and movement artifacts that could affect the analyzability of the scans in all clinical trials. Sites are notified as soon as possible (within 48 hours) if the subject needs to be called back to repeat any scans. A special “Scan Acceptance Assistance Program” was developed by BNAC to better assist sites during scan acquisition. Imaging exams are reviewed independently by several key members of the clinical trial team including an MRI engineer, the project manager, a clinical neuroimager and medical doctors specialized in imaging analyses. A final determination is made for quality both visually and quantitatively during a consensus meeting of the trial team. Sites are notified of scan acceptance and projected imaging schedules are distributed on a regular basis.

The query resolution process is part of a continuous, ongoing communication between either the sites/sponsor and BNAC or the CRO/sponsor and BNAC.  Query resolution, in a broad sense, is covered in SOP (Clinical Trial Transfer Tracking and Query Procedures) but the process is subject to adjustments based on the needs of the study and the communication plan developed among all involved parties.  Typically, BNAC sends queries immediately upon noticing them and requests that the site or CRO follow-up on resolution within 3 business days. If no resolution has been provided in that timeframe, the sponsor is notified.

 

Safety Monitoring

BNAC tracks study-defined lesion number thresholds (“safety rule”) and will contact study personnel if a subject exceeds lesion count/volume and requires clinical assessment in all MS clinical trials. A certified neuroimager reviews scans to confirm lesion activity (gadolinium-enhancing and new T2 lesions) or vascular abnormalities. If needed/depending on sponsor/study requirements, neuroimagers can also provide an incidental findings review. 

 

Outcome Measures Calculations

BNAC offers a variety of imaging measures of the brain, spinal cord, and optic nerve for research studies and clinical trials.

 

Customized Status Reports and Compliance Documentation

BNAC works closely with trial sponsors in the development and distribution of web-based status reports. Examples of reports that have been developed for our trials include but are not limited to site-specific tracking files, subject enrollment and protocol adherence, as well as analysis reporting. Schedules for report distribution vary and are dependent upon agreements between BNAC and the sponsoring agency. 

All components of the imaging process are documented for sponsor, site and BNAC records. Examples of activities that require documentation include scan collection, scan acceptance, site certification, database queries, projected subject imaging schedules, and scan evaluations.

 

Secure Electronic Data Transfer

The BNAC maintains a computerized system for online image transfer, compliant with both 21 CFR Part 11 and local privacy regulations. The site provides a relay for DICOM data to be transferred, while stripping potential PHI on the client side. Our online transfer site uses encrypted transfer to ensure data security in transit.

 

Quality Assurance Program

BNAC standard operating procedures (SOPs) have been developed in accordance with the International Conference on Harmonisation (ICH) and the Code of Federal Regulations Title 21 (CFR-21 Part 11). A detailed list of all SOPs that govern clinical trial conduct can be provided upon request. Periodic system assessments are performed to ensure that all SOPs and software systems at the BNAC are in compliance. In addition, all personnel responsible for the development of either SOPs or systems software complete CFR-21 Part 11 training that includes Good Clinical Practice principles and recommendations. 

All research conducted at BNAC goes through a rigorous review process prior to implementation. BNAC works closely with the Institutional Review Board at the State University of New York University at Buffalo to ensure that all study conduct is in accordance with the principles that ensure the integrity of the research and supports the spirit of working with human subjects in a clinical research setting. 

 

Post-trial services

 

Post-Analysis Data Processing

The BNAC computes a variety of conventional and non-conventional qualitative and quantitative brain imaging measurements: estimates of T2-, T1-, gadolinium-enhancing lesion volumes, lesion activity analysis and calculation of global and regional magnetization transfer ratio, diffusion weighted and tensor imaging measurements, magnetic resonance spectroscopy, computerized tomography, magnetic resonance and digital subtraction angiography, functional imaging, perfusion and atrophy imaging indices, and spinal cord and optic nerve imaging.

 

Publications and Report Dissemination

BNAC is committed to high quality research and generating top level publications in the field. Its many existing peer-reviewed publications, books and book chapters reflect this high-quality research activity. Consequently, BNAC requests authorship for its participating staff on any papers originating from the proposed imaging services.