Leveraging our clinical design and operational experience with
medical devices, taking into account the technical characteristics,
usage environment, and regulatory requirements of medical devices, we provide
customized clinical trial solutions optimized for each medical device.
medical device clinical trials
We provide a one-stop solution that covers the entire process from approval of medical device clinical trial plans (Investigational Device Exemption, IDE) to clinical performance and regulatory approval. We design clinical trials by comprehensively considering the product's intended use, class, technical characteristics, etc., and present step-by-step, optimized execution plans encompassing the selection of trial institutions, recruitment of clinical trial participants, and monitoring.
CNR Research's specialized medical device team provides systematic and efficient services across all aspects of clinical trial design, data management, statistical analysis, document preparation, and regulatory agency communication, reflecting the latest global regulatory trends. We support the successful commercialization of products by shortening development periods.
Medical Device Clinical Trials
In the rapidly changing medical device industry and complex regulatory environment, we provide strategic clinical trial solutions that reflect the intended use and technical characteristics of your product. Based on our accumulated experience with medical devices of various grades, we support clinical services that cover the entire product development cycle, including Exploratory Clinical Trials and Confirmatory Clinical Trials for approval, as well as post-approval clinical trials.
CNR Research's medical device specialist team establishes execution strategies that combine scientific validity and feasibility, and through clinical operations that meet the latest global regulatory requirements, we professionally guide our customers' medical devices to enter domestic and international markets quickly and stably.
With expertise and practical experience specializing in the development of diagnostic and therapeutic medical devices, we provide full-cycle clinical solutions that reflect the technical characteristics and regulatory requirements of each product. We analyze the operating principles and user environment of medical devices to design customized protocols that scientifically demonstrate clinical efficacy and safety. From the initial stage, we systematically establish key strategies such as sample size calculation, subject selection, and performance and safety evaluation indicator setting.
To ensure the reliability of clinical trial data, we apply real-world evidence (RWE) collection and statistical analysis methodologies, while preparing documentation and reporting strategies for submission to regulatory agencies.
C&R provides comprehensive support throughout the entire medical device clinical trial process, from planning and clinical execution to data analysis and regulatory response, to help our clients’ devices achieve successful market entry and maintain strong competitiveness.
clinical development with C&R Research.