REVIEWS

IBC services

Institutional biosafety committee (IBC)

The fastest IBC timelines in the industry and more registered sites than any other IBC mean safer, more efficient conduct of your genetic engineering research.

Biosafety support for every project, anywhere

Accelerate study startup

Minimize delays with rapid review timelines.

10 days or less from submission to review.

Largest gene therapy network

Advarra is registered with the NIH as the IBC of record for 1,500+ research sites that are vetted and prepared to conduct your next clinical trial.

Learn more about Advarra’s Gene Therapy Ready Site Network

Optimize safety and compliance

Save time and resources while ensuring consistency with integrated institutional review board (IRB) and IBC reviews across all participating sites.

Unmatched expertise and insights

Access experts in all prevalent types of genetic engineering and gene-transfer technologies employed in research on rare diseases, infectious diseases, and oncology.

The most comprehensive IBC and biosafety services

IBC setup and registration support

Establishment of Advarra-administered local biosafety committee
Recruitment and staffing of qualified personnel
Implementation of industry-leading laboratory safety procedures
Complementary NIH registration and ongoing registration management

Protocol review and approval

Research protocol review
Issuance of approval documentation
Ongoing monitoring and support solutions
IBC compliance and management
Year-round compliance management
On-demand review services
Site audit services
Compliance reporting to the National Institutes of Health (NIH)

Education, training, and operations consulting

Research staff training
Laboratory safety
Biohazard education
Protocol, standard operating procedures (SOPs), and informed consent form (ICF) consulting

IBC-ready local IBC submission support

Complete local IBC forms accurately and efficiently with expert support
Coordinate submissions through a single entity
Eliminate confusion for investigators and study coordinators unfamiliar with IBC questions
Have support available regardless of the study’s IBC of record

Materials required for submitting a study to the IBC

Featured content

White Paper

Emerging Use of Bacteriophages, Natural Predators of Bacteria, to Combat Antibiotic Resistance in the Clinic and Beyond: A Review of the Field and Biosafety Assessment

Explore the latest research on bacteriophage therapy, including advances in clinical development, biosafety, and regulation.

Blog

Does mRNA Require IBC Review? How the NIH Guidelines Apply to Clinical Trials

Let me start with a question I get more and more frequently from research sites as mRNA continues to expand

White Paper

When Do Clinical Trials of mRNA Products Fall Under IBC Review

Discover how AI and analytics are transforming clinical trial operations, from study startup to accrual workflows, in this insightful whitepaper.

Blog

Gene Therapy Is Seen as the Next Big Biologic in Ophthalmology

Over the last 15 to 20 years, monoclonal antibody-based treatments, such as those targeting vascular endothelial growth factor (anti-VEGF), have

Blog

Cell & Gene Therapy vs Drug Research: What’s the Difference?

Cell and gene therapy’s popularity has grown exponentially in the past year. However, it’s important to understand how cell and gene therapy research is different from traditional drug development.

Blog

Does This Study Require IBC Review?

Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.

Blog

IBC vs. IRB: What’s the Difference?

Gene therapy research requires both IRB and IBC oversight—while IRBs protect participants, IBCs ensure community and environmental safety with local site-specific reviews.

Info Sheet

Institutional Biosafety Committee (IBC) Services Info Sheet

Advarra’s IBC services offer rapid, flexible solutions for IBC review, especially critical for gene therapy and other high-stakes research.

Technology-enabled reviews

All of our reviews are supported by our best-in-class technology platforms, which provide clients with real-time information on review timelines and deliverables. 

Improve compliance and reduce administrative burden with the most integrated reviews solutions in the industry.  

Advarra’s review technologies integrate easily into a sponsor’s electronic trial master file (eTMF) platforms and site systems via APIs. 

Learn more

Frequently asked questions

Explore our comprehensive FAQ page for detailed answers to questions about our IRB, IBC, data monitoring committee (DMC), and endpoint adjudication committee (EAC) services.

Find your answers