C&R Research’s website has been honored with the Grand Prize in the Healthcare Services category at the 'Web Award Korea 2025'.The award recognizes the site’s clear visual representation of C&R’s professional expertise, along with its advanced content strategy and highly competitive user experience across the platform. Read the text | Ref: Newspim

  Partnership to develop video data management, analysis, and research solutionsTrial Informatics, a company specializing in AI-based clinical trial IT solutions, announced on the 16th that it signed a memorandum of understanding (MOU) with the Seoul Asan Medical Center Clinical Trial Center on the 15th and established a strategic partnership for the management and analysis of clinical trial image data and the development of research solutions.The two institutions will further strengthen their collaboration in the area of ​​clinical trial image data. Through various activities, including the commissioning and acceptance of imaging-related research projects, they aim to enhance research accuracy and reliability, contributing to the development of the clinical trial industry and future medical innovation. The Seoul Asan Medical Center Clinical Trial Center will be responsible for various image interpretations, while Trial Informatics will handle data management based on an IT platform.  Read the text | Ref: Edaily

C&R Research, Korea's first contract research organization (CRO), recently received two clinical trial approvals (IDE and IND) from the US FDA, solidifying its position as a global clinical partner.C&R Research recently secured two consecutive IDE and IND approvals from the US FDA, demonstrating its global clinical capabilities. First, IMGT's 'IMD10', an access ultrasound system for pancreatic cancer treatment, received FDA IDE (Investigational Device Exemption), laying the foundation for the initiation of clinical trials in the US.  Read the text | Ref: Consumer Times

 Independent research firm GL Research reported on the 11th that C&R Research is undergoing a full-scale transformation into a global CRO (Contract Research Organization) as the transition to an AI (Artificial Intelligence) and data-driven clinical platform accelerates.C&R Research achieved its highest-ever performance yet, posting cumulative sales of KRW 49.8 billion in the third quarter of this year, a 9.4% year-on-year increase. Multinational clinical trial revenue reached KRW 7.8 billion, representing 17% of total revenue, demonstrating the company's rapid transformation into a global CRO.  Read the text | Ref: Money Today

  Strategic Collaboration with Mediplexus, a Leading Real-World Data SpecialistC&R Research signed an MOU on December 5 with Mediplexus, a specialized Real-World Data (RWD) and Real-World Evidence (RWE) healthcare data company, to strengthen competitiveness in clinical research based on real-world data.Through this collaboration, the two companies aim to strengthen their data, AI, and platform capabilities using hospital-based real-world data, driving innovation and improving clinical research efficiency. This will support C&R Research’s shift toward a ‘Data CRO,’ enabling more integrated services from study design to regulatory and post-marketing support.Moontae Yoon, CEO of C&R Research, stated, “This collaboration marks an important starting point in advancing personalized, data-driven clinical research. It will create new momentum to achieve both patient-centered product design and reductions in research time and cost. By combining the extensive healthcare data and clinical expertise of both organizations, we will establish a differentiated Data CRO business model, set new standards for clinical processes, and lead the future competitiveness of the industry.”  Read the text | Ref: Yakup News

BCG: "The CRO industry will undergo a major restructuring over the next decade."C&R integrates AI and data into its end-to-end platformContract Research Organizations (CROs) are a core infrastructure of the biotechnology industry. CROs comprehensively manage the entire clinical trial process and serve as strategic partners, enabling pharmaceutical and biotechnology companies to focus on new drug development.This shift is also being felt domestically. C&R Research, a domestic CRO, is attracting industry attention as it builds a new growth model through technology-based service expansion and digital transformation.  Read the text | Ref: Bizwatch

  Global Regulatory Expertise in ADC-Based ModalitiesC&R Research announced that Intocell’s investigational solid tumor therapy, ITC-6146RO, has received FDA approval for its Phase 1 IND application.ITC-6146RO is an innovative anticancer candidate developed using Intocell’s next-generation ADC (Antibody-Drug Conjugate) platform, featuring proprietary linker–payload technology designed to improve drug safety and enhance toxicity management.Throughout the IND review process, C&R Research led CTD strategy and preparation, managed FDA communications, and handled regulatory feedback, demonstrating the company’s strong global regulatory capabilities in the field of advanced biopharmaceuticals.  Read the text | Ref: Hankyung

  Interview with Byungin Yoon(President of C&R Research), and Kyungwon Kim(CEO of Trial Informatics)C&R Research and Trial Informatics(TI) are building a CRO model incorporating AI technologies, taking steps to secure a foundation for competing in the global market.The two companies are targeting global expansion through a strategy that automates repetitive tasks—from clinical data generation to analysis—using AI-based RPA, and integrates imaging reading, collection, and analysis into a single platform.Dailypharm met with Byungin Yoon, President of C&R Research, and Kyungwon Kim, CEO of Trial Informatics and Professor of Radiology at Asan Medical Center, to discuss the collaborative model and future plans of the two companies.President Yoon stated, “The competitiveness of a CRO depends on how accurately and efficiently it can utilize data, and the industry is shifting from manpower-based operations to a technology-intensive, data-centric sector. We are establishing the framework for transitioning to a data-driven CRO and will continue developing an all-in-one solution that enables integrated management on a single platform.” CEO Kim said, “Clinical endpoints were traditionally specimen-based, but today CT, MRI, skin imaging, and even surgical videos can serve as biomarkers. Imaging provides objective evidence, and AI can standardize, measure, and interpret it.”  Read the text | Ref: Dailypharm

C&R Research announced on the 25th that IMD10, a connection ultrasound system for pancreatic cancer treatment by IMGT, a medical device company, has obtained approval for a clinical trial plan (IDE) from the U.S. Food and Drug Administration (FDA). The approval was made by C&R Research with C&R US.As the first FDA IDE approved case achieved by leading the entire clinical trial, It is evaluated as a meaningful achievement that successfully broke through the barriers to global clinical entry of domestic medical devices.With the approval of IDE, C&R Research has developed clinical expertise and response capabilities in the global regulatory environment. It is being evaluated that it has been officially verified. IMD10 was already designated as an FDA Breakthrough Device in February. Technology and clinical potential have been recognized.With this IDE approval, clinical trials in the United States are officially possible, Key procedures for global commercialization have begun in earnest.In particular, IMD10 is used in combination when administering anticancer drugs. It is based on technology that enhances drug penetration into pancreatic cancer cells.This complements the drug delivery limitations of existing treatments,It is attracting attention as an innovative approach that can increase the effectiveness of pancreatic cancer treatment. Read the text | Ref: Edaily

 C&R US Accelerates IND Success and Expands Cross-Border PartnershipsSeoul, Korea South, 18th Nov 2025 – Established in 1997 as Korea’s first full-service Contract Research Organization (CRO), C&R Research has played a pioneering role in shaping the nation’s clinical research industry. With nearly 30 years of regulatory and operational expertise, the company has earned the trust of global pharmaceutical and biotech partners. In 2023, C&R Research expanded into the U.S. market with the launch of its subsidiary, C&R US, marking a significant step in its global growth strategy.Now in its second year, C&R US continues to expand its presence through trusted partnerships with U.S.-based pharmaceutical companies, biotechnology firms, and CROs.The company has successfully supported multiple Investigational New Drug (IND) applications across key therapeutic areas, including atopic dermatitis, solid tumors, biosimilars, and medical devices, while also providing Pre-IND meeting support to help clients design efficient early-stage development strategies.  Read the text | Ref: Digital Journal / Binary News Network