Moon-tae Yoon, CEO
In the age of the fourth Industrial Revolution, Korea's pharmaceutical and medical device industries are facing a more intensified global competitive landscape. To become a forerunner to lead the new industrial paradigm, seeking business diversification and globalization on the part of Korean companies will be an integral part for success. Korean pharmaceutical companies and bio companies often lack R&D or marketing capability as they do not have in-house global study teams, which leads them to hire foreign CROs for global market entry and to establish a business strategy. This led Moon-tae Yoon, an expert in the pharma industry, to found C&R Research, a full-service CRO that provides a comprehensive scope of clinical services for Korean pharmaceuticals and medical device companies. "Our primary goal is to support small to mid-sized Korean pharmaceutical companies that have limited means to conduct international clinical trials on their own," says Yoon, CEO of C&R Research.
C&R Research, established in 1997, is the first full-service CRO in Korea and has grown to become Korea's leading CRO. The company offers full-service coverage, including arranging contracts, drug development consulting, regulatory affairs, medical writing, clinical operation, project management, data management, statistical analysis, CSR writing, medical consulting, quality assurance, publication, education, and training. With its expertise, diverse network, and experienced staff, C&R Research ensures the delivery of efficiency and excellence in clinical services to optimize the client experience. For 24 years, with expertise in clinical development of pharmaceutical and medical device products, it has completed more than 1,500 projects and licensing procedures across most treatment areas.
A testimony to C&R Research's pharma abilities is a Korean bio company that needed to expedite the New Drug Application (NDA) for its fine-wrinkles product to be the first-in-market for the preparation of botulinum toxin. Due to the difficulties in coordinating staff and time management, the client sought support from C&R Research for efficient project management expertise in clinical operation.
Our primary goal is to support small to mid-sized Korean pharmaceutical companies that have limited means to conduct international clinical trials on their own
C&R Research helped the client make effective decisions through prompt issue sharing and communication strategies for sponsors and drastically reduced the timeline for the stages LPO to CSR, from the initial 19 weeks to 11 weeks. This helped the client's product to receive the fourth approval in the market. C&R overcame the challenges and established its expertise by streamlining each departments’ project preparation, project manager appointment, and task management processes.
With a well-established market in Korea, C&R Research's goal is to become a total value chain CRO that provides end-to-end services, including technology investment and incubation, training programs, joint development services, and production distribution. Over the years, C&R Research also established integrated services through its subsidiaries and partners in Korea, China, and APAC regions. It now aims to become a global CRO that covers major regions, including the U.S. and Europe. Currently, C&R Research is planning an M&A with a U.S. CRO to provide essential management and operation support to initiate early-stage clinical development for sponsors who may have a lack of experience in the U.S. and foreign market.
C&R Research is also operating an incubation business in Singapore, aiming to support Korea healthcare startups’ entry into foreign markets. C&R Research has also developed a Central Lab to collect specimen from clinical trials in multiple sites to one laboratory for accurate clinical trial results based on GCLP (Good Clinical Laboratory Practice) in collaboration with a Korean company. In fact, some of C&R's global projects in China, the U.S., Bulgaria, and Australia are working in collaboration with local partners. C&R Research established an entity in China to enable numerous Korean pharmaceutical companies to enter the Chinese market as clients. What's more, C&R Research established CDISC systemization and central monitoring service to secure reliable and high-quality clinical data compliance with global standards. By operating the project and central monitoring simultaneously, C&R Research can identify risks in the early stage and reduce unnecessary time and cost, which results in positive feedback from the clients.