Key Information About BRANY's Biomedical Research Services
BRANY, the Biomedical Research Alliance of New York, offers support services to research sponsors and investigators in various therapeutic areas. Established in 1998, it collaborates with academic institutions, conducting quality clinical trials and providing efficient research services. BRANY's Institutional Review Board (IRB) reviews over 4000 studies and serves as a Single IRB for multisite trials. Their IRB team ensures timely reviews, audits, and communication, maintaining compliance with industry standards. Partnership with BRANY extends the reach of research oversight for organizations and ensures adherence to institutional requirements.
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Presentation Transcript
What is Biomedical Research Alliance of New York (BRANY)? A national organization providing support services to sponsors and investigators involved in research in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials. Staffed by multi-disciplinary experts
About BRANY Organized September 1998 Four Owner Institutions NYU Montefiore Medical Center Ichan School of Medicine at Mount Sinai Northwell Health (Formerly North Shore - Long Island Jewish Health System) BRANY Staff 56 employees Institution s served = 40
Philosophy Support researchers in their mission to conduct quality clinical trials Serve as consultants and advisors to researchers when developing or enhancing their clinical research programs Provide industry partners efficient and quality research services
About BRANYs IRB BRANY IRB Composed Of Academic Owner Institutions IRB Members Over 4000 Industry Sponsored, Investigator Initiated, and NIH funded studies reviewed since 1998 COI Review Committee AAHRPP Accreditation in December 2006 , re-accreditation in 2009 and 2014 Serves as Single IRB for Multisite Trials (e.g. NYC CDRN) The BRANY IRB team partners with your organization s IRB and/or research office to ensure your staff and investigators remain connected to their BRANY-IRB reviewed research studies, enhancing your organization s research oversight.
Cont. BRANYs IRB Two Scheduled Meetings per week Daily Expedited Reviews Notification of IRB Decisions Within 2 Days of Meeting IRB Audits of sites participating in trials with vulnerable populations IRBManager Online Submissions, Tracking and IRB downloads
BRANY acts as an extension of the Institution by following institutional requirements and procedures. BRANY follows the institutional requirements for use of an external IRB Communication pathways are established with BRANY/Institution staff to ensure internal approvals are in order before submission to the BRANY IRB (Pharmacy, Radiation Safety, Conflict of Interest, HSP Training) Liaisons at the Institution have access to all records and submissions via IRBManager A unique study registration forms can be established in BRANY s IRB submission system (IRBManager) with workflows embedded specific to the Institution BRANY applies Institution s Informed Consent Form Requirements (e.g. subject injury) BRANY enforces Institution s HSP Training Requirements HIPAA requirements (Waivers/Privacy Board Determinations) BRANY works collaboratively with the Institution to define the process for reporting to federal agencies
Integrated workflows Work closely with investigators to ensure smooth communication between our IRB and the participating sites. To do this, we have developed: Workflows and alerts to investigators and research coordinators at all sites Specific notifications alerting of unanticipated events occurring at the organization Customized reports listing deviations, SAEs and other critical information Organizational access to BRANY IRB s electronic protocol management system, IRB-ManagerTM
Cont. Fees Initial review of 10 new studies, the total for the first year (presuming they all have a one year approval period and no amendments) = $20,500. If all studies stay active for one year they will require continuing review. Continuing review for 10 studies = $11,500 If along the way, a protocol amendment (Modification per the fees schedule) is initiated, and the consent form needs to be updated the fee is $395. This fee is charged each time a modification is submitted to the IRB for review. The same process applies for Study Materials (e.g. advertisements) for each submission after the initial review $250 is charged. In cases, where an organization is transferring active studies, there is a transfer fee. The process for transfer is a little different than processing a new study. We treat those similar to a Continuing Review, so the $1,150 fee would apply.
