Provider Overview

BRANY provides organizations with a strong infrastructure of clinical trial support services that assists clinical researchers in their pursuit to conduct quality clinical research. BRANY’s clinical trial study start-up services include:

• Contracts
• Budgets
• IRB Administration
• Research Education
• Monitoring
• Enrollment Tracking
• Research Billing and Collections
• Medicare Coverage Analysis

Facility Description

For more than 15 years, BRANY has provided outsourced and consulting clinical research services to academic medical centers, community hospitals, sponsors, and independent research sites across the United States. In addition to providing centralized IRB review, site selection, contracting, budget, Medicare Coverage Analysis, auditing and monitoring services to its owner institutions, BRANY provides services to institutions all across the continental United States. Our central office is located in New York, but sites are nationwide.

Clinical Research Experience

BRANY provides IRB administration for more than 1100 active research trials and coordinates the study start-up process (IRB submission, contract and budget negotiation) and manages the study start-up, research revenue tracking through study close-out for over 600 new and continuing clinical trials annually.

Investigator Experience

EXPERIENCED RESEARCHERS
Our researchers include over 2700 board-certified physicians across all specialties with clinical trial experience from premier academic medical institutions. Many of our investigators are considered "thought leaders" in their fields.

EXPERT CONSULTANTS
BRANY offers sponsors a robust panel of expert investigators and scientists to assist in protocol development, DSMB membership and medical monitoring.

Staff Expertise

EXPERIENCED STAFF
BRANY is staffed by over 50 professionals with expertise in human subject protection, clinical research administration, research education, and finance.

Patient Demographics

Our Institutions provide a gateway to a potential trial pool of over 3 million patients in the New York tri-state area.

Other Services

SMART START- 60 Services for Trial Sites include:

• Study Procurement - BRANY’s business development team receives new trial opportunities daily. Such opportunities are offered to Institutions and researchers to help increase the flow of new trials to research programs and ultimately lead to increased clinical trial revenue. BRANY’s Business Development team will meet with researchers to appraise their goals related to research and work with them to develop targeted goals to optimize their standing with research sponsors and CROs
• Contract and Budget Negotiations according to Institution requirements
• Informed Consent Preparations
• IRB Review
• BRANY IRB has two scheduled meetings per week
• On-line submissions, tracking and IRB downloads
• Administrative Support

CONTRACT AND BUDGET NEGOTIATIONS
BRANY can negotiate the budget and/or contract on behalf of Institutions. BRANY staff works closely with investigators and research staff to optimize potential revenue for all clinical trials. BRANY’s high standards and attention to detail also apply to contract construction and negotiation process. BRANY’s experienced legal team can provide expertise in ensuring appropriate contract terms, such as indemnification, options to publish, satisfactory insurance limits, and confidentiality provisions. We do not interfere with the relationship between your organization, investigators and sponsors.

RESEARCH COMPLIANCE
BRANY’S compliance team includes Physician Assistants, Registered Nurses, and Emergency Medical Technicians all with 15 plus years experience with research. These professionals are well versed in the regulations governing research including:

• Title 45, Code of Federal Regulations (CFR), part 46 – Protection of Human Subjects, Title 21, Code of Federal Regulations (CFR), Part 50 - Protection of Human Subjects, Part 56 - Institutional Review Boards (IRB), Part 312 - Investigational New Drugs, and Title 49 Transportation of Infectious Substance, as applicable./li>
• International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guidelines

BRANY compliance personnel will conduct quality assurance reviews as directed by an Institutions Administration. The review includes monitoring for compliance with IRB requirements, the regulations, good clinical practice (GCP) and guidelines set forth by the International Conference on Harmonization.

Copies of BRANY QA review reports are submitted to an Institution’s Administration as directed. While the purpose of the QA review is generally considered to be corrective and not punitive, any serious protocol violations (whether discovered by BRANY audit or other means) will, as soon as discovered, be brought to the attention of Institutions liaison.

MEDICARE COVERAGE ANALYSIS
BRANY will analyze an institutions clinical research trials in accordance with the most current policies and guidelines of the Centers for Medicare & Medicaid Services to determine the eligibility of a clinical trial for Medicare coverage and review the clinical events specified in the protocol to determine which can be reimbursed by Medicare. For studies that qualify for Medicare coverage BRANY will:

• Provide a written Medicare coverage report based on the review of clinical trial protocols, Clinical Trial Agreements, and ancillary study documents
• Provide Medicare coverage billing plan for all qualifying studies
• Communicate relevant details of the completed coverage review with individuals responsible for negotiating the clinical trial budgets so that they are able to build budgets and ascertain the financial responsibilities of the sponsor, a patient's insurance, and the originating department
• Provide training to investigators and research coordinators enabling them to assign encounters to the appropriate category (bill to sponsor, bill to payer, non-billable)

In addition to the above services for drug trials, BRANY will communicate with the local Medicare contractor to achieve the final necessary coverage determination for device trials. BRANY will:

• Submit IRB-approved documents (protocol and consent), fully-executed clinical trial agreement and budget to the local Medicare contractor for final review
• Make any necessary adjustments according to local Medicare contractor’s response
• Provide confirmation from local Medicare contractor

BRANY also offers MCA compliance audits to ensure adherence with Medicare coverage analysis determinations in accordance with the most current policies and guidelines of the Centers for Medicare and Medicaid Services. BRANY will:

• Review Medicare coverage determination of selected clinical trial including participant's clinical events specified in the protocol
• Provide on-site research billing compliance review
• Provide Institutions with written reports of findings from research billing compliance review

PROTOCOL BUILDER
Protocol Builder is the first-of-its kind solution that makes writing investigator-initiated protocols in less time with less effort. Protocol Builder helps institutions and single users, such as medical residents, create better quality investigator-initiated protocols by providing a consistent platform for researchers to develop protocols that meet IRB and regulatory standards.

IRB SERVICES
The BRANY IRB is composed of academic researchers with extensive IRB experience. Members are committed to the protection of human subjects and ethical and quality research review in the most efficient manner. Ongoing auditing of approved trials assures compliance with all regulatory agencies.

IBC SERVICES
BRANY assist sites that want to do research involving bio-hazardous agents that don’t already have an IBC with setting up their own IBC.

• We provide core members with appropriate expertise, and we use our network to obtain local members, which is a requirement. Then we assign a bio-safety officer at the site who acts as liaison to the IBC and works with us to get appropriate documentation in place pre and post IBC review
• Turnaround time is highly dependent on responsiveness of the investigative site. If the site is very responsive, we can have a committee set-up, registered with NIH and an IBC meeting scheduled within about 4 weeks. This can be accomplished sooner if the site already has an IBC administered through BRANY