What is BRANY?
BRANY is an outsourcing agent for Montefiore and Einstein for some of our clinical trials portfolio. Montefiore - Einstein IRB automatically accepts BRANY IRB determinations. Some additional services rendered by BRANY include contracting and budgeting, along with regulatory administration and study invoicing for services. BRANY is also available to provide monitoring services for investigator-initiated studies. Investigators at Montefiore and Einstein are able to use BRANY and their services conjointly or selectively. OCT staff will help you sort your way through this. See BRANY website
- BRANY Submission - The Office of Clinical Trials will assist a Principal Investigator and Study Coordinator in sorting their way through BRANY submissions. BRANY has their own application and regulatory submission process as well as requirements for continuations, amendments, and Serious Adverse Event reporting by the Principal Investigators and study coordinators. All trials being sent to BRANY must be authorized by the Office of Clinical Trials. The process is as follows:
- Submit a STUDY ACTIVATION FORM to the Office of Clinical Trials.
- Submit theBRANY IRB APPLICATION form and required documentation.
When Should I Work With BRANY?
Trial participation initiated by BRANY must be reviewed and processed by BRANY. If you have been invited to participate in a clinical trial by BRANY, you must use their services as your IRB and have them act as an agent on your behalf for the contractual and budget process.
Some investigators make use of BRANY’s many master trials agreements with pharmaceutical companies, which can faciliate contracting and study activation. The OCT staff can help in deciding where to direct study management, be it internally or with BRANY.
How Is BRANY Used?
Investigators at Montefiore and Einstein are able to use BRANY and their services conjointly or selectively. There is a separate application process for projects sent to BRANY directly, with BRANY’s own regulatory submission requirements for continuations, amendments, and SAE reporting by the PI/research team.
- All trials being sent to BRANY must also be registered with the OCT. This is done by submission of a protocol and STUDY ACTIVATION FORM to the OCT indicating that a project is being submitted to BRANY.
- BRANY does not perform Montefiore - or Einstein-specific regulatory work – i.e. research billing plans, Medicare-coverage submissions or Medicare Coverage Analysis. These procedures are completed with the help of the OCT and our Compliance department.
Where Is BRANY Located?
1981 Marcus Avenue
Lake Success, New York 11042
516.470.6900 P 516.470.6903 F
Who Should I Contact Here When I Have a New Study?
Office of Clinical Trials- BRANY Point of Contact
MARC SCULLIN, M.A.-- Clinical Trials Supervisor, Regulatory (New Studies)
718.920.4774 P 718.515.6039 F
Who Should I Contact at BRANY When I Have a New Study?
CASIE MILLER — Senior IRB Coordinator (Initial Review)
516.470.6931 P 516.706.4985 F