Copernicus Group IRB

Research ServicesNorth Carolina, United States11-50 Employees

Copernicus Group IRB (CGIRB) operates as an independent institutional review board, focused on safeguarding the rights and welfare of human research subjects by reviewing study protocols, investigator qualifications, and resources to ensure regulatory compliance. Based in Lake Park, North Carolina, the organization serves as a potential IRB for single investigators or as a central IRB for multi-center trials that can involve thousands of investigators, and may act as the IRB of record for studies conducted at hospitals or academic institutions.

Founded in 1996, CGIRB aligns its operations with applicable regulations and guidelines governing IRBs, including FDA and federal requirements, and has earned accreditation through AAHRPP and ISO certification. The firm has a history of regulatory inspections by the FDA without findings, and maintains registration with OHRP and the FDA under the Federalwide Assurance, supporting reviews of human subjects research funded or conducted by HHS. The organization operates within the research services sector, offering services that support ethical review and regulatory compliance for human subjects research.

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