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

CONTACT US

Services & Resources
IRB Committee
IRB Committee
IRB Administration
Workflow Review & Recommendations
Consent Requirements Review
IBC Services

Process Highlights
Easy submission
Short learning curve
IRBManager^TM web-based software
Training, instructions sheets, tutorial videos,
one-on-one sessions
Easy amendments and continuing reviews
Frequent Meetings
Twice weekly IRB Meetings
Daily expedited IRB Reviews
Fast turnaround times
Feedback/questions within 48hs
Written approvals within 48hs
Expedited review decisions within 48hs
Dedicated Client Managers

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.

Service-oriented. Solution flexibility.
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. We work the way that works for you. And there’s no project 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 administrators and committee members are committed to providing the highest quality ethical review. We provide expertise in all therapeutic areas, including:

Gene transfer
Rare diseases
Oncology
Pediatrics
Digital health and more.

Expert Committee & IRB Staff
Our founders and current owners are the top academic medical centers in the New York City area, giving us the ability to bring together top clinical and allied health professionals into our IRBs. 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. BRANY staff includes Certified IRB Professionals, legal experts, and research professionals many with more than 10 years of experience in IRB administration.

IRBManager^TM online software
Our IRB management system helps streamline the IRB review process by enabling online submissions and amendments, sending electronic alerts, and storing key documentation, such as IRB policies and determination letters.

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
Our IBC Services can help expedite the review process for recombinant DNA or human gene transfer research while providing rigorous biosafety oversight. Learn more.

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.