By maintaining detailed protocol throughout a clinical trial, BNAC provides a professional environment that delivers optimal results. We offer a number of trial operations services that assist with evaluating each step of analysis with the highest level of quality. Learn more below about the ways we structure trial operations at BNAC.
- Dummy Run Scan Assistance Program
- Clinical Trial Call Center
- Scan Acceptance Assistance Program
- Safety Monitoring
- Outcome Measures Calculations
- Customized Status Reports and Compliance Documentation
- Secure Electronic Data Transfer
- Quality Assurance 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.
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.
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.
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.
BNAC offers a variety of imaging measures of the brain, spinal cord, and optic nerve for research studies and clinical trials.
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.
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.
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.