Get ahead with an IBC services provider with unmatched experience reviewing human gene transfer clinical protocols.
If your gene transfer research requires Institutional Biosafety Committee (IBC) approval, then seek expert advice on oversight.
Accelerate Study Start-up
Our experts have extensive experience in all aspects of site startup for human gene transfer research, from product handling to site selection and more. Expedite your study’s start-up by weeks or months compared to a typical local biosafety review.
Coordinate IRB & IBC Services
Each committee is composed to conduct reviews for different purposes but shares goals of ensuring trial integrity and protecting those involved. When coordinating IRB and IBC review of gene transfer studies through WCG, you can unclog bottlenecks.
Increase Exposure to Clinical Trial Participation, for Research Sites & Institutions
WCG works with some of the world’s largest sites down to small, local clinics. And the ultimate catalyst to finding sponsors who want to work with you is joining our global network of IBC-registered sites.
Access Unmatched Experience & Quality
Our review teams work closely with clinical coordinators and investigators at each site, addressing needs with personalized, proven solutions for safety and compliance. We are also ISO 9001 certified to ensure we deliver the highest quality service and meet the highest standards.
Receive Transparent & Interactive Reviews
Our processes are transparent and interactive. We enable sponsors and CROs to confidently navigate the steps required for IBC approval. And we empower sites and institutions to direct compliance activities.
Work with the Leading Gene Therapy Advisory Board
WCG’s Gene Therapy Advisory Board applies a combined 200+ years’ experience in gene transfer research. Our Board provides our clients with expert guidance and strategic counsel on the changing landscape of research in gene therapy.
Understand Our IBC by the Numbers
active sites in WCG’s IBC network across 19 countries
research sponsors, hospitals, clinics, and academic medical centers worldwide
unique protocols reviewed since 2020
submissions reviewed since 2020
Institutional Biosafety Committee FAQ
IBCs are tasked with mitigating risks posed by gene transfer research to clinical staff, public health, and the environment. Each clinical trial site must have its own biosafety registration, and IBC membership must include scientific experts qualified to evaluate the research under study. Each Institutional Biosafety Committee must also include two community representative members who live near, but are not affiliated with, the clinical trial site. Learn more about key elements of biosafety review.
All human gene transfer clinical trials inside or outside the U.S., if subject to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), require approval by an IBC (most drug products that incorporate engineered DNA or RNA qualify as human gene transfer products and are subject to the NIH Guidelines). Our experts can help you determine whether your trial requires biosafety review and review prospective site lists to create the perfect startup approach for each site requiring biosafety review. Read more about research that requires IBC approval.
The requirement for biosafety review is separate from, and in addition to, the requirement for IRB review. An IBC may, however, advise an IRB in assessing potential risks to study subjects. With proper planning, IRBs and IBCs can work together to ensure safe, efficient, and compliant site initiation. Learn more about navigating IRB and IBC reviews and about WCG’s IRB review.
Yes! You can register with multiple IBCs. In fact, by registering with multiple Central IBCs, you increase your site’s chances of being selected for participation in a clinical trial.
Don’t Chance Your Human Gene Transfer Research.
Partnering with WCG puts it in the best hands. We’ll help you every step of the way, from timeline and enrollment dates to qualification of prospective sites to document preparation and distribution. Experience the WCG difference starting with a free biosafety services consultation.
Have you already submitted your study for IBC review with WCG and have questions? Please contact us at [email protected], and we’d be happy to assist!