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Clinical Research Consulting Completes Multinational Training Program for Principal Investigators from Beijing, China and Duke University
Boston, Massachusetts, April 3, 2008 – Clinical Research Consulting, Inc., a contract research organization (CRO) specializing in clinical monitoring, project management, education and training, announced today that it has completed training for investigators involved in an investigator-sponsored study led by Duke University in conjunction with the Beijing Cancer Hospital and Peking University. Six investigators from Beijing joined investigators and other research personnel from Duke for the one and a half day training session led by Lisa Mazurka, President of Clinical Research Consulting, Inc. The formal training session was conducted at the Duke Comprehensive Cancer Center, in Durham, NC and covered FDA regulations, Good Clinical Practice Guidelines, and additional topics that are imperative to investigators such as informed consent, investigator responsibilities, protocol compliance, adverse events, documentation, non-compliance, fraud and FDA suspension. “Our goal for the training was to provide the clinical investigators from Beijing a complete overview of U.S. standards to assure consistency in the clinical studies being conducted in the U.S. and China,” said Vijaya Chadaram, Clinical Trials Manager at the Duke Comprehensive Cancer Center. “We were very pleased with the results. Clinical Research Consulting presented a professional training program that was tailored specifically for our needs. While the investigators from Beijing are experienced, they are now well versed in U.S. standards and compliance issues,” she added. Dr. Wei Chen, Assistant Professor and Program Director for the Duke Comprehensive Cancer Center added: “It is critical to the success of this global program that we generate credible data that is in compliance with all regulations, in the U.S. and China. Using an external professional consultant, like Lisa Mazurka and Clinical Research Consulting, to augment our internal training ensures that our investigators are fully informed and knowledgeable about all of the mandatory guidelines,” he said. “Investigator training is important in collaborative studies, particularly when there are cultural and philosophical differences involved,” said Lisa Mazurka, President of Clinical Research Consulting, Inc. “Our goal is to ensure that investigators and researchers have the common knowledge and training required to perform the clinical studies consistently and in compliance with all U.S. standards and regulations.” Clinical Research Consulting, Inc. specializes in worldwide on-site training for clinical researchers and investigators that is tailored to the specific organization’s research focus. The company also provides interactive educational courses that can be completed online. A photograph of Lisa Mazurka and the clinical investigators involved in the training is available at https://eclinicalresearchconsulting.com/pics/duke.jpg. About Clinical Research Consulting, Inc. |
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