✦ C&R INSIGHT TALKIn a fast-changing global clinical environment,where is change driven by data, technology, and people heading?C&R’s perspective goes beyond simply interpreting clinical trends.It extends to practical strategies developed with clients and leadership, which drive organizations forward.In this interview, we take a closer look at the key insights behind it all — from shifts in the global clinical industry and C&R’s competitive strengths to the leadership philosophy at its core.✦Q1. With your extensive experience in global CROs, how do you view the strengths and limitations of domestic CROs in comparison?One of the greatest strengths of domestic CROs is their close relationships with clients.Beyond simply responding to client requests, domestic CROs differentiate themselves by developing a deep understanding of clients’ internal environments and organizational structures, and by managing projects with a shared goal of successful drug development.This strength is particularly evident in projects with domestic biotech ventures and small-to-mid-sized pharmaceutical companies, where flexible and customized support is essential due to limited resources.At the same time, compared to global CROs, there is still room for improvement in areas such as multi-regional clinical trial experience and advanced consulting capabilities. Strengthening clinical development expertise, including CRA capabilities, will be an important focus moving forward.✦Q2. In this environment, how does C&R differentiate itself? C&R is a No.1 CRO driving the transformation into a Data-Driven CRO.C&R has built differentiated competitiveness through a well-structured organization and a team of highly skilled professionals capable of delivering end-to-end clinical development services.Its expanding global network across key regions, including the United States, Thailand, and Indonesia, and its experience in multi-regional clinical trials represent clear strengths. These capabilities are reflected in its strong project management, which is recognized as a key strength of C&R.In addition, by leveraging RWD/RWE-based data and AI-driven analytics, C&R generates more precise clinical evidence while enhancing both the speed and accuracy of decision-making.Building on these capabilities, C&R is further strengthening its position as a global CRO.✦Q3. Alongside AI, what key trends should we watch in the future global clinical trial environment?AI-driven data analytics, risk-based quality monitoring, and the expansion of decentralized clinical trials (DCT).As mentioned earlier, AI technologies enable more sophisticated analysis of large-scale clinical data and help proactively identify potential risks, improving both the quality and efficiency of clinical trials. At the same time, the growing adoption of remote monitoring and decentralized clinical trials (DCT) is fundamentally transforming traditional operating models.These changes go beyond the adoption of new technologies, leading to a redefinition of the roles and responsibilities of clinical professionals. As these changes continue, organizations need to stay responsive and adapt accordingly. Ultimately, how effectively they respond will define their competitiveness.In response to these global trends, C&R continues to enhance its capabilities to deliver stable and efficient global clinical trials, supported by AI-powered, data-driven expertise and flexible operational models.✦Q4. Within C&R’s flexible strategy, client collaboration must also be important. What values do you prioritize in working with clients?Accurately understanding client needs and working together as 'One Team'.At C&R, we place strong emphasis on clearly understanding our clients’ needs and delivering customized solutions.More importantly, we focus on working together with our clients as 'One Team', aligning on shared goals and working side by side. In addition, through collaboration with our group company TI, we have developed AI-based clinical IT solutions that enable data-driven decision-making while improving both the speed and accuracy of project delivery.Ultimately, C&R is not just a service provider, but a "One-Team partner" that works alongside clients to solve challenges and achieve success together.✦Q5. What are C&R’s goals and strategic direction over the next five years?C&R aims to grow beyond a leading Asia-based CRO representing Korea and establish itself as a global CRO.C&R continues to expand its capabilities in multi-regional clinical trials, with a strong focus on key markets such as the United States, Thailand, and Indonesia. Looking ahead, the company aims to extend its role beyond an Asian clinical trial hub and further broaden its participation in global projects.In the long term, C&R aims to become a trusted partner with meaningful influence across global clinical markets beyond Asia.✦Q6. With extensive leadership experience, what matters most to you as a leader?A leader should show the direction of the organization through actions, not just words.Of the many qualities of leadership, what I value most is 'walking the talk' and being a 'role model'. I believe leaders should lead by example, demonstrating their values through actions so that team members can naturally trust and follow them.In today’s workplace, where open communication and being genuine are increasingly valued across generations, empathetic leadership is more important than ever.Early in my career, I joined a global CRO as Country Manager in Korea, where I focused on driving business growth while building a stable and well-structured organization. I was later promoted to General Manager, and being recognized as a role model by my team remains a meaningful foundation for my leadership today.✦Q7. What advice would you like to share with the next generation of leaders?I encourage you to embrace who you are and find joy in the small, meaningful moments of everyday life.While the future may feel uncertain due to rapid advances in AI and technology, I encourage you to focus on what you can do today rather than worrying about the distant future. Take time to appreciate the small moments of happiness in everyday life and allow yourself to fully experience them.As small achievements and moments of joy build over time, they create the strength to move forward with confidence, even in the face of bigger challenges and change.One principle I value is thinking from the other person’s perspective and making decisions with a win-win mindset. When combined with sincerity, this helps create the way forward, even in an uncertain future.To all aspiring leaders, a single small step today can lead to meaningful change tomorrow.Trust your choices, stay true to yourself, and move forward with confidence.Thank you.✦ Misook Hyun | Vice President• Sungkyunkwan University (B.S. in Pharmacy, M.S. in Clinical Pharmacy)• Former Country Head, Korea at Quintiles (now IQVIA); prior experience at Chong Kun Dang, Sang-A Pharmaceutical, and Sanofi-Aventis• Recipient of the Minister of Health and Welfare Award (2018)

 We are pleased to announce the 5th C&R Webinar, taking place on April 29. Under the theme,'Beyond Response: How MRD is Transforming Cancer Treatment and Drug Development',this webinar will explore the scientific significance of MRD in line with the latest regulatory trends,as well as the evolving strategies in clinical development. Medical Advisors, Dr. Yongju Chung and Dr. Eunsoo Lim will shareinsightful sessions offering strategic perspectives to enhance the probability of success in clinical trials.Please be advised that this webinar will take place privately due to operational considerations. We appreciate your understanding and look forward to seeing you at a future event. * [Session 1]✔ Topic: MRD, the Invisible Signal of Cancer: Scientific Insights and Clinical Value✔ Speaker: Dr. Yongju Chung – Medical Advisor (MD, Pharmacist)[Session 2]✔ Topic: A Turning Point in Multiple Myeloma Drug Development:Accelerated Approval Strategies under FDA MRD Draft Guidance✔ Speaker: Dr. Eunsoo Lim – Medical Advisor (MD, Internal Medicine Specialist) 

  C&R Reporter brings you the latest updates from C&R Research.C&R Research is expanding its global clinical networkacross Asia as an Asian Global CRO.With the establishment of its Indonesia office,C&R Research is further enhancing clinical operations across the ASEAN region.What defines C&R Research’s Asian Global CRO strategy?Let’s explore C&R Research’s Asia-focused clinical strategy.  Q. What is C&R Research's Asian Global CRO strategy?A. It is a CRO that connects Asia to global clinical trials.• Deep understanding of local regulations and clinical environments • MRCTs enabled through cross-country collaboration• Integrated clinical operations across diverse populations and dataThis strategy expands Asia into an integrated clinical hub beyond single-country operations.     Q. Why is Indonesia a key focus for C&R Research?A. Indonesia is a key market for expanding clinical trials across the ASEAN region. • Growing demand for MRCTs from global pharmaceutical companies • Rapidly expanding clinical trial landscape in ASEAN• A population of 280M with diverse population characteristicsIndonesia continues to play a key role in clinical research across ASEAN.Q. What has changed with the establishment of the Indonesia office?A. C&R Research is expanding its clinical operations across Asia through its Indonesia office.• Stronger clinical collaboration between Korea and ASEAN • Expanded MRCT capabilities across the ASEAN region• Integrated operations with existing global affiliatesThis supports more flexible and efficient global clinical trial management.C&R Research is expanding its clinical capabilities across Asia through its Indonesia office.Integrated regional operations strengthen multi-regional clinical trial capabilities.As an Asian Global CRO, C&R Research supports global clinical trials with stability and expertise.Learn more about C&R Research’s global clinical strategy on our website.Thank you for your continued interest in C&R Research.

 C&R Reporter is here to deliver clinical insights from C&R Research.The global clinical trial landscape is rapidly evolving.With the revision of ICH E6(R3) Good Clinical Practice, the core guideline for global clinical trials,new standards are being introduced across the entire clinical trial lifecycle. Recent global regulations are shifting clinical quality management from traditional operationaloversight toward a Risk-based Quality Management approach.C&R Research operates as an End-to-End CRO,partnering with sponsors in today’s evolving clinical environment.In this article, we explore the key updates of ICH GCP R3 andhow the role of CROs is evolving within the changing global regulatory landscape.  Q. Why is the ICH GCP R3 revision important for clinical trials?A. ICH E6(R3) Good Clinical Practice redefines quality managementby reflecting the realities of modern clinical trials.The revision emphasizes building quality into clinical trials from the design phase.Key concepts include: • Risk-based Quality ManagementProactive risk identification and management• Data ReliabilityEnsuring reliable and high-quality clinical data• Quality by DesignBuilding consistent quality from the earliest trial design stageThese principles emphasize structured management across the clinical development lifecycle.   Q. How is the role of CROs evolving under new global regulations?A. As global clinical regulations evolve, CROs are expanding beyond operational supporttoward comprehensive clinical development management. Clinical trials involve interconnected processes including development strategy, protocol design,clinical operations, data management, and statistical analysis. Ensuring quality and efficiency now requires an integrated,lifecycle-based approach rather than managing each phase independently.CROs are evolving into strategic partners managing the full clinical development processwhile ensuring global regulatory compliance.Q. How does C&R Research operate clinical trials?A. C&R Research supports the full clinical development lifecyclethrough an End-to-End clinical operating model.From early development planning to study completion,we build an integrated framework where every phase works seamlessly together.As an End-to-End CRO, C&R Research provides:• Clinical StrategyClinical development planning• Protocol DesignStudy protocol development• Regulatory AffairsGlobal regulatory strategy and submissions• Clinical OperationsTrial management and monitoring• Data ManagementClinical data management• BiostatisticsStatistical analysis and CSR preparationIn today’s rapidly changing global regulatory environment,connectivity across the clinical development lifecycle has become more important than ever.C&R Research delivers global-standard clinical trials as a trusted End-to-End CRO partner.Explore our integrated clinical development solutions on our website.Thank you for your continued interest in C&R Research.

 C&R Reporter is here to introduce C&R Research’s latest data-driven innovation.C&R Research is strengthening its capabilities as a specialized Data CROfocused on clinical data.Recently, in collaboration with Mediplexus,C&R Research launched a Hybrid Clinical Solutionconnecting clinical trial data with real-world data(RWD). Here’s what has changed.We introduce the C&R x MPX Hybrid Clinical Solutionand C&R Research’s Data CRO strategy.  Q. What is the C&R x MPX Hybrid Clinical Solution?A. It is a solution that integrates clinical trial data with hospital-based real-world data(RWD). • Mediplexus: Provides hospital EMR-based real-world data(RWD)• C&R Research: Provides data design, standardization, statistical analysis, and reportingBy integrating EMR-based real-world data with standardized research data,the solution generates regulatory-grade real-world evidence(RWE) for decision-making. This enables faster and more precise data-driven decisionsin Risk Management Plan(RMP) and pharmacovigilance research.    Q. How does C&R Research operate data-driven clinical trials?A. C&R Research operates through dedicated data teams. • Data Management: Data collection and management• Biostatistics: Statistical analysis• Medical Operation: RWD-based study planning and reporting• RWO: Clinical operation support From data generation → cleaning → analysis → reporting, C&R Research manages the entire process within one integrated system,ensuring data quality and consistency.Q. What differentiates C&R Research as a Data CRO?A. C&R Research is a specialized Data CRO that transforms data into actionable evidence.• Designs data for regulatory readiness• Implements data strategy across clinical development to post-authorization studies• Applies strategic data utilization in RWD∙RWE environmentsC&R Research is a Data CRO that transforms data from numbers into decision-ready evidence.C&R Research is a Data CRO that manages the full clinical data lifecyclefrom generation to regulatory application.As RWD and RWE expand,C&R Research remains a strategic clinical partner that turns data into value.Learn how C&R Research, a Data CRO,provides end-to-end clinical solutions by visiting our website.Thank you for your continued interest in C&R Research.

 C&R Reporter is here to show how we recharge and thrive at C&R Research. C&R Research is an End-to-End CRO with over 500 clinical experts,supporting the entire clinical process from planning to conduct, data management and reporting. To help our experts work sustainably and confidently, C&R Research offers special employee benefits.  Q. Where do you head first when you arrive at C&R Research?A. The first-floor lounge, featuring coffee, tea, and book lending. It’s where most staff naturally stop in the morning.Even the C&R Reporter starts the day here with a cup of coffee. Coffee and a variety of teas are available to start the day on a positive note. A bookshelf in the back offers book lending for staff leisure, with new titles shared every month.Q. What kinds of books are available?A. The lounge offers a variety of books,from pharmaceutical, biotech, and clinical references to hobby reads for leisure. On the first floor at C&R Research, staff can take a relaxing pause with these books.  Q. What kind of space is on the top terrace at C&R Research?A. The C&R Terrace, a sky garden for staff.It’s a place to enjoy the open sky and nature up close,perfect for a relaxing pause or a light discussion with colleagues.Q. What experiences are available at the C&R Terrace?A. The terrace features workshops, lunch, and relaxation for staff.It also hosts departmental events, and on sunny days, staff can enjoy lunch outdoors.It’s a unique and comfortable spot at C&R Research for recharging during the workday.Q. What unique benefits does C&R Research offer beyond its workspace facilities?A. Family Day and Lunch Day provide staff with flexible work hours and a free lunch.These special benefits give staff time,helping them naturally balance work and personal life.Q. How are Family Day and Lunch Day organized?A. Staff receive two early leaves and two free lunches each month.On Mondays, office staff can enjoy a free lunch,allowing them to focus on work without worrying about meals.On Fridays, staff work only in the morning and leave early,giving them a more relaxed afternoon.Q. What are the benefits of Family Day and Lunch Day?A. They help staff balance work and personal life, and enjoy time with colleagues.Twice a month, staff can manage personal schedules more flexibly and spend relaxed moments over a free lunch.Q. What is the biggest advantage of working at C&R Research?A. As an End-to-End CRO, we support work efficiency while providing clinical experts a stable work environment. C&R Research maintains a healthy balance between work and rest, so everyone can focus with ease.  Learn more about End-to-End CRO solutions at C&R Research on our website.We look forward to sharing more updates from C&R Research with you.