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

   C&R Research (CEO Moontae Yoon) announced today that it will hold its second webinar on October 29th. The webinar, titled 'LNR (Lab Normal Range) Mastery: From Raw Data to Reliable Insights,' will provide an in-depth, integrated guide for the proper collection and application of Lab data in clinical trials.LNR is essential for safety evaluation and ensuring data reliability in clinical trials, but it carries a high risk of errors, particularly in long-term, multi-center studies. This webinar will predict potential errors that can occur during the data collection process and propose practical quality control strategies applicable to real-world scenarios.The webinar will consist of two main sessions:In the first session, Heoncheol Ha, Team Leader 1 of Data Management at C&R Research's Information Division, will present 'Collect it Right: Error Prevention in Lab Normal Range Collection'. This session will introduce solutions aimed at minimizing errors during the LNR collection phase.In the second session, Jinseok Kim, Team Leader 3, will discuss 'Beyond Collection: Quality Management & Regulatory Alignment'. He will analyze the risks associated with applying LNR to EDC (Electronic Data Capture), propose standardized management strategies, and present effective management methods through real-world case studies.Sookjung Jo, Vice President of C&R Research's Information Division, stated, "This webinar will offer practical solutions to systematically resolve the difficulties in LNR management. We believe it will provide clinical professionals with valuable insights and enhance their practical competitiveness through our differentiated strategies and real-world application cases."The webinar is free and registration is available through the official C&R Research website. Pre-registration is open until the 24th of this month. Access links will be sent individually via email to pre-registered attendees.  Read the text | Pharmnews

   Strengthen your strategic partner status  C&R Research announced on the 26th that it successfully concluded the event with differentiated expertise and on-site communication at Asia's largest clinical conference "2025 Conference on International Clinical Trials (KIC)."KIC, which marks its 11th anniversary this year, held various programs such as conferences and exhibitions under the theme of "Innovation of Clinical Trials through Technology, Diversity, and Cooperation," and more than 1,500 people, including bio and clinical experts, participated in the event from 20 countries around the world.Through the operation of the booth, C&R Research focused the attention of clinical industry officials such as pharmaceutical companies, biotech companies, and hospitals. At this meeting, we exchanged the core capabilities of C&R Research for integrated whole-cycle clinical services and discussed in-depth partnering with participants to explore the possibility of future cooperation.In addition, we conducted a joint survey with family members (GCCL, Trial Informatics, TI Image, C&R SMO, and ABC Bioscience) on the overall organically connected pre-cycle services. It received great response as a place to identify the needs of the industry and listen to the voices of participants.In particular, the presentation session presented by C&R Research at this KIC presented a key strategy to look at the future of new drug development by conducting under the themes of innovative statistical design techniques of early clinical trials (Sookjung Jo, Vice President), Korea's global clinical trial hub background and know-how of C&R (Yunho Kim, Executive Director) and DSUR strategic use of new drug development (Hwang So-yeon, Part Manager)."This KIC is an important place to broaden the horizon of cooperation by sharing C&R Research's overall clinical trial strategy and rich global experience," said Moontae Yoon, CEO of C&R Research. "We will use this as a stepping stone to solidify our position as a strategic partner with domestic and foreign pharmaceutical bio companies and grow as a strong partner in new drug development." Read the text | Hankyung