CIRBI

CIRBI is Advarra's secure, proprietary technology platform that powers the company's Institutional Review Board (IRB) services. Designed to support rigorous, efficient, and transparent ethical review of clinical research, CIRBI serves as the operational backbone for Advarra's gold-standard IRB process. The platform is built for sponsors, CROs, and research sites of all sizes — from emerging biotechs to all top-20 pharmaceutical companies — and supports more than 72,000 sites across the United States and Canada.

Advarra is the largest central IRB, with more than four decades of ethical review leadership. Its unified IRB model brings together the heritage of several leading independent IRBs, combining proven strengths and best practices with deep scientific, regulatory, and therapeutic expertise. The organization's people-centered approach emphasizes collaboration, accountability, and transparent communication, with 87% of submissions coming from returning customers.

CIRBI Platform Capabilities

• Serves as a single source of truth for submissions, required actions, study status, and board decisions
• Integrates directly with the site's eReg system, the sponsor's eTMF, and Advarra's Study Collaboration tools to reduce administrative burden and strengthen documentation quality
• Features intuitive dashboards, adaptive forms, and pre-populated data that accelerate study startup and simplify ongoing submissions
• Provides study-wide transparency and standardized, streamlined workflows across multi-site research
• Supports forthcoming federal requirements mandating single IRB (sIRB) review for FDA-regulated trials through a proven framework built for complex, multi-site studies at scale

Review Speed and Quality

• More than 36,000 new U.S. site submissions and over 1,600 Canadian submissions reviewed each year
• First decisions on protocol submissions average five days after all required materials are received
• A disciplined review process ensures predictable, high-quality outcomes for even the most complex studies
• Reviewers possess deep fluency in U.S. and Canadian regulations and are known for providing clear, well-supported rationales

Therapeutic Area Expertise

• Equipped to review studies across any therapeutic area or phase, including early-phase research
• Covers oncology, pediatrics, neurodegenerative and CNS disease, infectious disease, metabolic diseases, rare disease, and more
• Supports advanced therapeutic modalities including cell and gene therapy
• Reviews two times more oncology protocols than any other independent IRB, with 400+ oncology experts supporting reviews
• Holds seven times more IRB meetings per week with oncology representation compared to other independent IRBs
• Covers 100% of oncology indications and supports 100% of NCI Designated Cancer Centers
• Preferred provider for IRB and IBC services for leading oncology research institutions, including SCRI and START

Dedicated Support Model

• Each organization is assigned one dedicated coordinator who understands its specific workflows and goals
• Provides a single, reliable point of contact from study startup through closeout
• Partnership-driven model enables clear communication and smooth, efficient review processes
• Extensive experience supporting complex, multi-site research across all major therapeutic areas

Centralized Review and Regulatory Alignment

• Built to manage complex, multi-site studies at scale in anticipation of forthcoming FDA sIRB mandates
• Institutional experience and processes that organizations can rely on from day one
• Aligned with the ethical and regulatory expectations of sponsors, sites, and regulators
• Supports standardized, streamlined workflows through the CIRBI platform

Advarra's IRB services, powered by CIRBI, are grounded in a mission to ensure clinical research is conducted with uncompromising ethical principles, regulatory rigor, and the highest standards of participant protection. The platform's direct integrations with eReg, eTMF, and collaboration tools make it well-suited for organizations seeking to reduce administrative overhead while maintaining full compliance and documentation quality across all study phases.