Eminence Clinical Research, Inc .(ECR) is a premier contract research organization that provides quality services and products to efficiently bring new medical device products to market through assistance with strategy and tactical execution in clinical research, regulatory affairs, and quality assurance. ECR recognizes the importance of “time to market” and works diligently and with a true sense of urgency on your behalf. Our expert approach and personalized delivery is 100% focused on achieving the results you require for expanding your product portfolios and bringing new technologies to market. ECR professionals have your company's best interest in mind at all times. We only succeed when you succeed. •RA/QA Support to ensure a regulatory compliant quality system; •Regulatory Strategies and Submissions - from Path to Market Evaluations Reports to 510(k) premarket notifications to PMA submissions; •Clinical Trial Strategy from start to finish – strategy from First - in - Human to Feasibility to Pivotal to Post Market to Registries...to final report; •Clinical Trial Execution - from study design & protocols to pre-study site qualification to initiation, monitoring, and close-out; •Biostatistics and Data Management - From statistical analysis plan to electronic data capture build to data analyses; •Medical Writing - Support from literature reviews to publication of clinical trials in peer reviewed journals.