Clinical Research Consultants, Inc.
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Regulatory AffairsDescription
Cincinnati, OH 45220-2108
Clinical Research Consultants, Inc. provides consulting services in the fields of regulatory affairs (IDE, PMA, 510K, FDA), clinical trials management, quality systems regulations and management, manufacturing systems, operations, and strategic planning as they relate to research and development of medical devices and related technology. The consultants at Clinical Research Consultants, Inc. each have extensive experience in their respective fields of pharmacy, medical devices, engineering, business operations, and venture capital funding. CRC's services include strategic planning, preparation of regulatory submissions, clinical trial design, study management, monitoring, statistical analysis for both pre-market and post-market studies, and design, implementation and assessment of quality assurance systems to ensure compliance to US FDA GMP regulations, ISO standards, and European Union quality requirements.
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