Central IRB Services

“Going the extra mile is a big part of our DNA. Personal attention can go a long way in ensuring the success of your next research study.”

Raffaella Hart, MS, CIP
Sr. Vice President, IRB and IBC Services

Fast, reliable IRB review for multisite studies backed by expert oversight and responsive support. With streamlined submissions, frequent meetings, and dedicated client managers, BRANY IRB helps you save time and money while maintaining full regulatory compliance.

CONTACT US

BRANY IRB provides pharma, biotech and medical device companies with Central IRB Services that combine our service-first philosophy, our expertise and a proven, efficient process.

Central IRB Review That Adapts to Your Needs
With BRANY IRB in your corner, you’ll have a team of experts you can count on. Our collaborative approach means we can provide you with the ultimate flexibility. You are never just a number with us. If you have a question about IRB review or the submission process, we will take the time to make it crystal clear. No project is too big or task too small.

With BRANY Central IRB Services, you’ll get

Competitive pricing
Collaborative teamwork
Solution flexibility
Expert committee and IRB staff

Protocol Review Expertise in All Therapeutic Areas
Our experienced IRB leadership, administrators and committee members are committed to providing the highest quality ethical review. We provide expertise in all therapeutic areas, including but not limited to:

Gene Transfer

Rare Diseases

Oncology

Cardiology

Medical Devices

Pediatrics

Digital Health

Neurology

A Proven Central IRB Review Process

At BRANY IRB, we work the way that works for you. Here’s what you can expect when you partner with us:

	Easy Submission Submitting your documents, making amendments, and continuous reviews are all simple with IRBManager™. The platform is designed for a short learning curve, and all training, instruction sheets, tutorial videos, and one-on-one sessions are included
	Frequent Meetings Our IRB meets daily to ensure IRB review timelines align with your study timeline. Daily expedited reviews ensure urgent submissions are addressed quickly and efficiently.
	Fast Turnaround Times Receive feedback or answers to questions within 24 hours, keeping communication clear and consistent. Once the IRB’s questions or conditions are addressed, written approvals and expedited review decisions are delivered within 48 hours to maintain study momentum.
	Dedicated Client Managers You will be paired with a dedicated project manager who understands the details of your studies and timelines. This personalized support ensures smooth coordination and responsive communication throughout the trial.

Expert Committee & IRB Staff
Representation on our IRB committee includes thought leaders from a wide range of therapeutic areas with diverse backgrounds and decades of experience as IRB members.

Our founders and current owners are the top academic medical centers in the New York City area, giving us the ability to bring together leading clinical and allied health professionals as members on our IRB committee. Additionally, BRANY IRB leadership and staff include Certified IRB Professionals, legal experts, and research professionals, many with more than 10 years of experience in IRB administration.

MEET OUR LEADERS

IRBManager^TM online software
Our web-based IRB management system streamlines the entire review process, from submission to approval. Using IRBManager™ forms, you are guided to provide complete and accurate information, while automatic email alerts keep you updated at every step. All submissions, policies, and determination letters are securely stored in one place, making it easy to track progress and access essential documents anytime.

SEE HOW IT WORKS

Full AAHRPP Accreditation & Experience
We have full AAHRPP accreditation, which was granted in 2006. We also have over 20 years of experience serving as an IRB resource for pharma, biotech, and medical device companies.

IBC Services
In addition to Central IRB review, we offer IBC services to expedite recombinant DNA and human gene transfer studies while ensuring rigorous biosafety oversight. Our team of biosafety experts coordinates IBC and IRB reviews when appropriate, streamlining study initiation and reducing administrative burden for sponsors and sites.

IBC SERVICES

“The staff is outstanding. You are still speaking with a human and, nowadays, you can’t take that for granted.”

– Associate Director for Large CRO

Partner with a Central IRB That Works the Way You Do
At BRANY IRB, we make the review process simpler, faster, and more predictable. Our collaborative approach removes obstacles, adapts to your needs, and keeps your study on track. When it comes to expert Central IRB services, partner with the team trusted by leading sponsors and institutions nationwide.

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Frequently Asked Questions
Get answers to common questions related to central IRB services.

What is a Central IRB?

A Central Institutional Review Board (IRB) streamlines the IRB review process for multi-site research studies. Rather than each site having its own IRB review, the Central IRB will review the research study for all research sites to ensure that the research is designed and conducted ethically and that the rights and welfare of the research participants are protected.

What is the benefit of Central IRB oversight?

Working with a Central IRB for multi-site studies increases the efficiency of the IRB review process, adds consistency to the IRB review and reduces administrative burdens. Central IRB review also facilitates a consistent application of regulations across all participating sites, which strengthens the ability to protect research participants. The time savings and cost reduction associated with IRB review by a central IRB are also notable.

What factors do study sponsors take into consideration when selecting a Central IRB?

Study sponsors will generally consider the following when selecting a central IRB:

Years of experience serving as a central IRB
Therapeutic area expertise
Accreditation history
Staff certification and experience
Site network
Electronic submission system in place
Timelines
Processes and procedures

How does the Central IRB process work?

First, the CRO/sponsor submits to the Central IRB all relevant study-related documents, including the study protocol and informed consent form(s), as applicable. Once the IRB reviews and approves the research and the relevant study documents, the Central IRB will invite each participating site to submit its site-specific research application. The Central IRB reviews each site submission, ensuring it complies with ethical guidelines and federal regulations. Once approved, the study can proceed at participating sites under the direction of the CRO/sponsor.

Will the Central IRB require ongoing review of research studies?

For most research, federal regulations require that the IRB conduct substantive and meaningful continuing review of research at intervals appropriate to the degree of risk of the research. Continuing review will generally take place annually, but IRB approval periods may be shorter depending on the risk level associated with the research. Central IRBs will carry out continuing reviews of the studies and study sites under their oversight.

Can I submit updates or amendments to a Central IRB?

Yes, all modifications to a research study must be submitted to the Central IRB for review and approval prior to rolling them out to research participants. Modifications to research may include changes to the protocol, informed consent forms, or participant recruitment materials. The Central IRB will review these amendments/modifications to ensure they comply with ethical standards and regulations.