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

    Recognized for Fostering a Trusted Hiring CultureC&R Research announced that it received the Human Resources Development Service of Korea (HRDK) President’s Award at the 2025 Fair Recruitment Excellent Company Awards.The Awards were hosted by the Ministry of Employment and Labor and HRDK to promote a fair recruitment culture by sharing the achievements of companies with exemplary hiring practices.C&R Research was recognized for its efforts in transparent, competency-based, and candidate-centered recruitment practices, including providing timely information, incorporating candidate feedback into support programs, notifying results within five days, and offering explanations for rejection—demonstrating a trusted hiring culture across all stages.  Read the text | Ref: BIOTIMES

 The Korea Health Industry Development Institute (KHIDI), led by President Cha Soon-do, recently hosted “K-Blockbuster Night” at the Cambridge Innovation Center (CIC) in Boston, USA.As part of the K-Blockbuster Global Expansion Project, KHIDI has been operating the C&D Incubation Office within CIC since 2022, providing office space and networking opportunities for a total of 43 Korean bio-pharma companies by 2025.“K-Blockbuster Night” leveraged CIC’s weekly Thursday Gathering networking event to exclusively highlight the achievements of our resident companies. Nine companies — Yuhan USA, Huons USA, Dong-A ST, Intek Scientific, Mepsgen, VS PharmTech, C&R Research, Apollon, and Proteina — presented posters and promotional activities, connecting with approximately 500 participants from local pharmaceutical and biotech companies, research institutions, and academia.This event highlights Korea’s commitment to fostering global partnerships and promoting its bio-pharma innovations on the world stage.  Read the text | Ref: Bokuennews

 Strengthen the role of 'Data CRO' through digital data-driven clinical performance  C&R Research announced on the 7th that it has been selected as a participating organization in the 'Digital Bio Smart Clinical Support Platform Establishment and Development (K-HOPE Project)' organized by the Ministry of Health and Welfare.The project aims to digitize the Human Resources Bank, a national strategic asset, and establish a precision-customized clinical trial system by utilizing the latest technologies such as artificial intelligence (AI), metaverse, and digital twins. A total of 17.6 billion won will be promoted for three years from 2025 to 2027, and Hwasun Chonnam National University Hospital will be in charge of the organizing research institute.C&R Research is responsible for researching major cancer registry, clinical research using the Virtual Control Arm, and supporting the development of a smart clinical trial platform in this project.Until now, C&R Research has been leading the development of the clinical data utilization ecosystem by continuously conducting CDISC-based data standardization research as well as registry and virtual control research in rare and intractable disease areas.Yoon Byung-sun, head of C&R Research Institute, said, "Through this K-HOPE project, we will demonstrate our expertise in various ways so that medical technology can enter the clinical stage more quickly. We will build a Korean smart clinical trial model with global competitiveness by using healthcare data."   Read the text | Hankyung

     Leading the Establishment of New Standards in Clinical Trial Data ManagementC&R Research announced on the 30th that it successfully held its second webinar under the theme, 'LNR(Lab Normal Range) Mastery: From Raw Data to Reliable Insights’.LNR is an essential element that impacts all stages of clinical trials, including adverse event assessment and drug safety interpretation. With growing emphasis on clinical data quality and safety analysis, this webinar attracted significant attention across its key topics.During the webinar, Heoncheol Ha, Data Management 1 Team Manager, presented 'Collect it Right: Error Prevention in Lab Normal Range Collection', while Jinseok Kim, Data Management 3 Team Manager, delivered a talk titled 'Beyond Collection: Lab Normal Range Quality Management'.  Read the text | 출처: Yakup News

   Initiation of the FDA Pre-IND consultation process in collaboration with C&R ResearchEnsol Biosciences has initiated the FDA Pre-IND consultation process to assess the feasibility of a U.S. Phase 3 clinical trial for its osteoarthritis treatment candidate, E1K (Engedi1000). The candidate is currently under Phase 3 IND review by the MFDS.To support and strengthen its global clinical and regulatory strategy, Ensol Biosciences is working closely with C&R Research, Inc, which is providing comprehensive CRO expertise throughout the preparation.C&R Research, Inc is providing strategic oversight and guidance, with the goal of receiving FDA feedback in the first half of next year.  Read the text | Ref: Biz Watch