Korea’s clinical trial sector has spent the past two decades transforming itself from a fast follower into one of the industry’s most closely watched growth stories. Hyejin Kim, Chairperson of KoNECT, has been at the centre of that shift, steering the foundation’s push to connect investigators, hospitals, industry, and regulators around a single goal: putting Korea among the world’s top three clinical trial powerhouses. She speaks about what’s driving Korea’s competitiveness, how the country plans to hold its ground against China, and what it will take for Korean bio-ventures to turn a world-class pipeline into real global market share.
How has the clinical trial environment evolved in Korea and where does it stand today?
Over the past two decades, Korea has rapidly emerged as a trusted and strategically important destination for global clinical trials. Our competitiveness has been continuously strengthened by a synergistic combination of world-class medical institutions, highly skilled investigators, exceptional healthcare accessibility, an efficient patient recruitment environment, and state-of-the-art IT infrastructure.
Today, Korea is no longer just a prominent location for conducting clinical trials; we are actively evolving into a nation that discovers innovative drug candidates and boldly competes in the global markets.
Amidst this transformation, KoNECT serves as the “core bridge” and “central hub” that elevates Korea’s competitiveness in clinical trials to the next level. Guided by our vision to be a “people-centred public support agency driving Korea’s leap into the top three global clinical trial powerhouses,” we seamlessly connect investigators, medical institutions, industry players, and patients, as well as the government and regulatory authorities.
By fostering a highly collaborative and sponsor-friendly clinical trial ecosystem, we enable both domestic and global companies to leverage KoNECT as a strategic partner from the very early stages of drug development strategy and clinical design. Ultimately, our efforts are dedicated to helping Korea solidify its position not merely as a clinical trial destination, but as a definitive global leader in innovative drug development.
In light of China’s massive scaling and Beijing overtaking Seoul as the world’s leading city for clinical trials, how is KoNECT responding to regional competition?
We are closely monitoring China’s rapid expansion in the clinical trial sector, propelled by substantial investments and an immense patient population. While we recognise this as a significant challenge for the Korean clinical trial ecosystem, we simultaneously view it as a positive signal. The emergence of the broader Asia-Pacific region as a primary hub for global clinical trials presents new, strategic opportunities for Korea.
Rather than competing solely on volume or scale, Korea’s strategy is to differentiate itself through unparalleled quality, operational efficiency, and absolute reliability. Our core competitive advantages lie in our world-class medical infrastructure, highly experienced investigators, impeccable data quality, and advanced digital capabilities.
KoNECT is fully committed to ensuring that these strengths translate directly into national competitiveness. We will spare no effort in solidifying Korea’s position as a highly trusted partner and a premier, highly attractive destination for global clinical trials.
As decentralised methodologies and digital maturity become standard requirements for global sponsors, how is KoNECT translating digital tools into day-to-day practices for Korean sites?
In today’s global clinical trial landscape, digital transformation – encompassing eConsent, ePRO, remote monitoring, and wearable devices – is no longer an option; it is an imperative global standard. Korea is exceptionally well-positioned to integrate these digital tools into clinical practice, bolstered by our world-class IT infrastructure, near-universal Electronic Medical Record (EMR) adoption, and superior healthcare data management capabilities.
However, we firmly believe that the ultimate goal of digital transformation is not merely the adoption of technology itself. Rather, it is about enhancing patient accessibility, alleviating the operational burden on investigators, and fortifying data quality and integrity. Integrating digital tools is a complex endeavor that goes beyond simply deploying new tech; it requires a holistic approach that meticulously balances patient safety, data privacy, data reliability, and regulatory compliance.
With this in mind, KoNECT is providing multifaceted support to ensure that digital transitions are seamlessly embedded into day-to-day clinical trial operations. One example is ‘TrialforMe’, a public platform (portal) for participant recruitment. The portal allows people to find clinical trial information more easily and explore participation opportunities in a digital environment. It also supports more efficient patient recruitment and helps build an ecosystem that connects participants and investigators more effectively.
Furthermore, we operate the ‘Korea Clinical Trial Hub (K-CThub)’, a comprehensive portal offering extensive data on investigators, clinical sites, local vendors, regulatory frameworks, and epidemiology. Notably, K-CThub provides a data-driven feasibility service. This enables sponsors to efficiently identify the right sites and investigators and proactively assess patient enrollment potential. By doing so, we significantly reduce trial-and-error and preparation timelines during the planning and execution phases, thereby maximising overall operational efficiency.
Currently, KoNECT is spearheading a multi-centre pilot project leveraging core Decentralised Clinical Trial (DCT) technologies through the ‘SmartTech Clinical Research Centre’ (SCRC). This initiative rigorously validates the safety and practical efficacy of digital technologies within the Korean healthcare ecosystem. Through these efforts, we are establishing pragmatic, field-ready operational models and standard procedures, ensuring that digital methodologies are successfully and sustainably integrated into everyday clinical practice.
How does KoNECT collaborate with various government agencies, such as the MOHW and the MFDS, to advance the regulatory framework and industrial ecosystem of the clinical trial sector?
KoNECT acts as the pivotal bridge connecting government agencies – primarily the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) – with medical institutions and the broader life sciences industry. Leveraging the unique expertise and roles of each entity, we ensure that new policies and regulations are effectively implemented on the ground. Simultaneously, we facilitate continuous dialogue to ensure that the practical needs and insights from the clinical frontlines are actively reflected in policy and regulatory refinements.
In collaboration with the MOHW, our focus is on fortifying the fundamental infrastructure of the clinical trial ecosystem to enhance national competitiveness. We are driving key initiatives such as nurturing specialised clinical trial professionals, providing comprehensive clinical trial information support services, and conducting forward-looking R&D. Through these efforts, we are elevating domestic clinical trial capabilities and fostering an environment where investigators, medical institutions, and the industry can collaborate more organically and efficiently.
With the MFDS, our strategic partnership is centred on strengthening Korea’s capacity to respond to the rapidly evolving global regulatory landscape and cultivating a clinical trial environment that meets the highest global standards. Notably, KoNECT has been designated as a Centre of Excellence (CoE) by the APEC Regulatory Harmonisation Steering Committee (RHSC). In this capacity, we provide specialised training on international standards and regulatory trends for regulatory authorities and clinical trial experts across APEC member economies. Through this vital initiative, we are actively supporting both domestic and international regulatory harmonisation while significantly enhancing the global regulatory readiness of all clinical trial stakeholders.
Moving forward, KoNECT will continue to seamlessly bridge government policies and regulations with clinical practice, enhancing the practical execution of these frameworks on the ground while simultaneously strengthening the capabilities of both the industry and medical institutions. Through these efforts, we are fully committed to establishing Korea as a highly trusted clinical trial ecosystem that meets the highest global standards, ultimately accelerating patient access to novel therapeutic opportunities.
With over 1,300 domestic drug candidates discovered by local bio-ventures, what specific training, business development matching, or advisory services will KoNECT scale up to help these smaller companies successfully navigate the leap from local trials to global markets?
Korea currently ranks among the world’s top three countries in terms of its drug candidate pipeline, demonstrating that its drug development capabilities have already reached a globally competitive level. However, possessing a robust pipeline and successfully translating it into global market entry are two entirely different challenges.
KoNECT aims to support Korean bio-ventures in areas where they often face difficulties, including clinical trial design, global regulatory strategy, and international partnering.
First, we provide tailored consulting for global regulatory navigation. We provide customised advisory services led by international regulatory experts, enabling domestic bio-ventures to design their clinical strategies with the requirements of overseas regulatory agencies in mind right from the earliest stages of development. In addition, we host regular webinars to strengthen their capabilities in global clinical planning and operations, keeping them abreast of the latest clinical trends. We also organise knowledge-sharing workshops where companies can exchange practical experiences and success stories in drug development.
Second, we are expanding global partnering opportunities and promoting open innovation. The likelihood of success increases significantly when the extensive development expertise of established pharmaceutical companies is combined with the innovative technologies of bio-ventures.
To facilitate this, KoNECT annually hosts the KoNECT International Conference (KIC), the largest clinical trial conference in Asia. KIC serves as a premier platform for networking, practical business collaboration, and the forging of global partnerships. Furthermore, we actively support the overseas expansion of domestic companies and the attraction of global clinical trials by organising strategic delegations to major international congresses, such as ASCO (American Society of Clinical Oncology) and ESMO (European Society for Medical Oncology).
What collaborative frameworks is KoNECT establishing with international bodies (such as the FDA, EMA, or global CRO consortia) to ensure that clinical data generated at Korean sites is seamlessly accepted in multi-regional global applications without friction?
KoNECT maintains proactive and continuous engagement with global regulatory authorities, multinational pharmaceutical companies, global CROs, and relevant industry associations. Through this continuous dialogue, we actively promote the exceptional caliber of Korea’s clinical trial capabilities and data quality, thereby broadening the foundation for global collaboration. By facilitating high-level meetings, participating in international events, and driving strategic partnering initiatives, we serve as the vital link connecting domestic medical institutions with global partners. We provide critical information and identify collaborative opportunities to ensure that multi-regional clinical trials (MRCTs) are executed seamlessly within Korea.
We firmly believe that for Korean clinical data to be effectively utilised in the global arena, securing data quality and integrity that strictly adheres to international regulatory standards is paramount. To ensure that the domestic clinical trial environment consistently meets these rigorous global benchmarks, KoNECT actively shares the latest regulatory trends and standards with local stakeholders. Furthermore, we are continuously expanding our collaborative channels with overseas regulatory bodies, the global industry, and allied organisations.
Ultimately, our primary objective is to cultivate an ecosystem where the clinical trials conducted in Korea – and the data generated from them – are universally recognised as highly reliable, not only for MRCTs but also throughout the global drug development and regulatory approval processes.
Moving forward, KoNECT will relentlessly strengthen the connectivity between domestic medical institutions and global partners and continue to scale our international collaborations. Through these unwavering efforts, we will solidify the foundation that ensures Korean clinical data is seamlessly accepted and trusted in global drug development and regulatory submissions.
Do you have a closing message?
Korea is already well-recognised for its outstanding medical infrastructure, highly skilled investigators, impeccable data quality, and advanced digital ecosystem. Our critical imperative now is to further systematise these strengths and cultivate a truly people-centred clinical trial ecosystem – one that places the safety and rights of participants above all else.
Clinical trials are far more than mere scientific research; they are a vital process that provides patients with life-changing therapeutic opportunities and ultimately shapes the future of medicine. As a public support agency, KoNECT serves as the central nexus connecting the government, regulatory authorities, medical institutions, investigators, pharmaceutical and biotech companies, CROs, and patient advocacy groups. We strive to be a dedicated partner that actively listens to the voices from the clinical frontlines and delivers practical, highly actionable solutions.
Looking ahead, KoNECT will aggressively expand our core support initiatives – including data-driven feasibility services, global regulatory consulting, the establishment of a smart clinical trial ecosystem, and global partnering opportunities – to successfully propel domestic pharma, biotech, and bio-ventures into the global market. We remain fully committed to dedicating all our efforts to ensuring that Korea continues to thrive as a definitive, world-class powerhouse in global clinical trials and innovative drug development.
