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Advarra
Columbia, MD
About CRO
Advarra is a clinical research review, compliance, and technology partner supporting sponsors, CROs, research sites, hospitals, health systems, academic medical centers, and investigators across the clinical trial lifecycle. The company is best known for its IRB, IBC, research compliance, and clinical trial technology solutions that help studies move forward with stronger oversight, documentation, and operational visibility.
Overview
Advarra is built for organizations running clinical research that need trusted ethical review, biosafety oversight, site activation support, and connected research operations technology. Rather than acting as a traditional lab CRO, Advarra supports the infrastructure around clinical trials: IRB review, IBC review, CTMS, eRegulatory, eConsent, study startup, site collaboration, and research administration.
For sponsors developing drugs, biologics, medical devices, diagnostics, cell therapies, gene therapies, or early-phase clinical programs, Advarra can help reduce friction around review, compliance, documentation, and trial operations.
Accreditations & Compliance
Advarra provides institutional review board services through its CIRBI platform and reviews studies across therapeutic areas and phases, including early-phase research, oncology, pediatrics, CNS disease, infectious disease, metabolic disease, rare disease, and cell and gene therapy.
Advarra also provides Institutional Biosafety Committee services and is registered with the NIH as the IBC of record for more than 1,500 research sites. Their IBC services are especially relevant for gene therapy, viral vector, biologics, and other studies involving biosafety oversight.
Core Services
Advarra’s core services include IRB review, IBC review, biosafety consulting, study startup support, clinical trial management technology, eRegulatory workflows, eConsent, site collaboration, research administration tools, and clinical trial operational support.
Their IRB services are powered by CIRBI and are designed to support efficient review, communication, status tracking, and study oversight.
Their OnCore CTMS helps research organizations manage protocols, participants, finances, and clinical trial operations across research programs.
Advarra eReg supports paperless regulatory document management and includes 21 CFR Part 11 and HIPAA-compliant eConsent functionality as an add-on module.
Technology & Expertise
Advarra’s technology platform is designed to connect major pieces of the clinical trial workflow, including IRB review, biosafety review, CTMS, eRegulatory documentation, eConsent, study startup, and site collaboration.
Their ecosystem includes CIRBI for IRB management, IBC review technology, OnCore CTMS, Advarra eReg, and other trial operations tools. This makes Advarra a strong fit for sponsors and research organizations that need better visibility across study activation, compliance, participant management, document control, and institutional research operations.
Advarra is also widely used across the research ecosystem, with the company reporting 50,000 investigators using its solutions, more than 12,000 open protocols overseen annually, and 3,500+ institutions, hospitals, health systems, and academic medical centers using Advarra solutions.
Best Fit Projects
Advarra is a strong fit for clinical studies that need IRB review, central IRB support, IBC review, biosafety oversight, gene therapy trial review, clinical trial management infrastructure, eRegulatory documentation, eConsent, study startup support, site activation visibility, research administration, and compliance workflows.
They are especially well suited for sponsors, CROs, health systems, academic medical centers, and research sites running clinical trials where ethical review, biosafety oversight, documentation, and operational control are critical.
Why Work With Advarra Through CROaccess
Through CROaccess, sponsors can evaluate Advarra for clinical trial review, compliance, research operations, and technology support while comparing fit against other qualified CROs, regulatory partners, and clinical research vendors.
Advarra brings trusted IRB, IBC, and clinical trial infrastructure expertise, while CROaccess helps sponsors manage vendor discovery, proposal collection, documentation, communication, and project tracking in one centralized platform.
Technology & Expertise
Advarra brings together experience in Quality Assurance & Compliance, Regulatory Affairs & Submissions, Clinical Operations & Trial Management. Our teams apply quality-system oversight, audit readiness, CAPA, and controlled documentation; regulatory strategy, dossier development, submission management, and authority support; study start-up, cross-functional trial oversight, and operational delivery to create fit-for-purpose approaches for individual studies and broader development programs.
Core Services
Our core services at Advarra include Quality Assurance & Compliance, Regulatory Affairs & Submissions, Clinical Operations & Trial Management. Depending on program needs, engagements may cover risk-based quality management, vendor oversight, and inspection preparation; planning and delivery of regulatory documents across development milestones; feasibility, project management, site coordination, and study close-out, delivered as focused work packages or coordinated multi-function support.
Accreditations & Compliance
Our quality approach at Advarra is matched to the work being performed and the jurisdiction in which it is delivered. Clients may request current accreditation evidence, audit history, and site-level compliance documentation.

