Developing and marketing new medical products in today’s marketplace is a highly regulated process. Clinical Research Consultants (CRC) was established in 1992 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 clinical, and quality assurance consulting services to assist medical device and diagnostic product manufacturers in successfully meeting strict governmental requirements.

Our 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.
CRC’s goal is to assist you in developing and implementing cost-effective strategies and programs that meet the US FDA regulations for your specific medical products. We are responsive to our clients’ needs and provide high-quality, cost-effective service in a professional and confidential manner.

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