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

  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

    Jiwon Jung, Ph.D. (Statistics), Former MFDS Official, Introduces Multiplicity Adjustment via 'Graphical Approach'C&R Research (CEO Moon-Tae Yoon) will hold its third webinar on December 10, focusing on 'Graphical Approach to Multiplicity Adjustment in Clinical Trials'. The session will explore practical strategies for applying multiplicity adjustments in clinical trials and introduce the flexibility and strategic error allocation offered by the Graphical Approach compared to traditional methods.The Graphical Approach is a method for controlling the family-wise error rate (FWER) when multiple endpoints are tested simultaneously in clinical trials. By visualizing the testing structure, it allows for more intuitive trial design and interpretation.The webinar speaker, Jiwon Jung, Ph.D. (Statistics), brings extensive experience as a pharmaceutical statistics officer and former evaluator at the Ministry of Food and Drug Safety (MFDS). Now a BS Advisor at C&R Research, he provides statistical guidance across all stages of clinical trials. Drawing on his review of over 1,000 IND, NDA, and bioequivalence submissions at MFDS, Dr. Jung will share practical insights on trial design and multiplicity adjustment.  Read the text | Ref: Yakup News