Build Robust Research Processes
Whether you’re conducting a study or establishing best practices, Advarra can work alongside your team to refine your approach.
Get expert consultation and support for highly specialized — and highly complex — clinical trials.
Reinforce Safety Oversight
Leverage Advarra’s global reach to ensure compliant research across sites and around the world.
IBC review and oversight are essential for mitigating risks to study participants and researchers conducting studies involving recombinant (rNA) or synthetic nucleic acid (sNA) molecules. Institutions and sites that have either received NIH funds or are conducting NIH-funded studies involving rNA or sNA are required by NIH Guidelines to have IBC oversight.
Even if there are no NIH funds involved, IBC review is a best practice. Privately sponsored studies routinely employ commercial biosafety services to enable them to qualify for NIH funding, to support third-party regulatory requirements or for enhanced research safety oversight. NIH Guidelines state that “individuals, corporations, and institutions not otherwise covered by the NIH Guidelines are encouraged to adhere to the standards and procedures set forth” in the Guidelines (Section IV-D-1).
If you’d like Advarra to review your site credentials or new protocol, visit the materials required for submission page to learn about the submission process and requirements.
Advarra Provides IBC Collaboration Without Complexity
- Commercial IBC solutions to establish a new IBC, including flexible and comprehensive support for IBC setup, registration and administration
- Resources and support for an existing IBC in accordance with NIH Guidelines
- Coordination of concurrent reviews to deliver efficient, time-saving IBC and institutional review board (IRB) reviews for all participating research sites
- Global support for IBC services
Advarra’s IBC Services Team Supports Research and Clinical Trials Involving:
- Recombinant DNA
- Synthetic nucleic acid molecules
- Genetic engineering/gene therapy
- Infectious microorganisms
- Hazardous biological materials
Local IBC Submission Support with IBC-Ready™
With IBC-Ready, Advarra can help reduce confusion and administrative burden by coordinating with the sponsor, site personnel, and local IBC(s) to complete local IBC submission forms. Advarra’s experts can help complete local IBC forms accurately and efficiently, regardless of the IBC of record.
- Decrease timelines for local IBC submission and review
- Eliminate confusion for investigators and study coordinators unfamiliar with IBC questions
- Reduce administrative burden for site(s), CRO, and sponsor with a single entity coordinating submission for all local IBCs
- Service provided by biosafety processionals experienced in local IBC requirements and processes
Become a Member
Advarra is seeking IBC committee members, community members, site inspectors and consultants across the US to assist on a part time basis with IBC reviews and biosafety-related projects.
Submit a Study
The Advarra IBC portal simplifies study submission and reporting.
- Submit a new study, amendment or continuing review material and other reports
- Communicate with the committee and support staff
- Access approval documents
Our IBC services include:
Commercial IBC Setup and Registration Support
- Establishment of local biosafety committee(s)
- Recruitment and staffing of qualified personnel
- Implementation of industry-leading laboratory safety procedures
- Management of regulatory registration
Protocol Review and Approval
- Review of research protocols
- Issuance of regulatory approvals
- Ongoing monitoring and support solutions
- Local IBC submission support
IBC Compliance and Management
- Year-round compliance management
- On-demand review services
- Site audit capabilities
Education, Training and Ops Consulting
- Research staff training
- Laboratory safety
- Biohazard education
- Protocol, SOPs, ICF consulting
Turnaround can depend on a site’s experience with and preparation for IBC review. Sites that have an
existing IBC and prior experience with human gene transfer studies can often be reviewed and approved
in a few weeks. For sites that don’t have a registered IBC and that may be new to gene therapy research,
it usually takes 8-12 weeks from a complete submission to IBC review and site inspection.
Learn About IBCs and Clinical Trials Involving Recombinant DNA and Genetic Engineering
Ready for Solutions That Are Altogether Better?
Tell us what you’d like Advarra to do for your research program.