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Ohio Life Science Industry Directory
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Please note that we have a new site: LifeScienceHistory.com, "Where history is made daily" under development and
delayed by COVID-19, to be launched in 2023 replacing OhioLifeScience.com. Regrettably, we are working with reduced
staffing and the current industry directory is no longer being maintained, but will be replaced with a new and improved
directory upon the launch of the new site. We apologize for the inconvenience.
Clinical Research Consultants, Inc.
| | | Phone: | (513) 961-8200 | Fax: | (513) 961-2858 | Year Established: | 1992 | Main Contact: | Barbara Fant, Pharm.D, President | | Company Description | Clinical Research Consultants provides consulting services in the fields of regulatory affairs (including preparation of IDE, PMA and 510K submissions to the FDA), clinical trials management, quality systems regulations and quality systems management, manufacturing systems, operations, and strategic planning as they relate to research and development of medical devices and related technology.
Clinical Research Consultants (CRC) was established in response to numerous requests from sponsors and investigators for assistance in the design, placement conduct, and reporting of clinical research studies. The staff of CRC offers regulatory, clinical, and quality assurance consulting services to assist medical device and diagnostic product manufacturers in successfully meeting strict governmental requirements.
CRC services include:
Strategic planning for US product introductions. Preparation of FDA regulatory submissions, including IDE's, 510(k)s, and PMAs.
Clinical trial design, study management, monitoring, and statistical analysis for both pre-market and post-market studies.
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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