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2025. 12. 19

GCCL: An Integrated All-in-One Lab Partner for Multinational Clinical Trials

*Life Sciences Review / December 18, 2025 - https://cro-apac.lifesciencesreviewapac.com/vp/-gccl/gccl:_an_integrated_all-in-one_lab_partner_for_multinational_clinical_trialsGCCL: An Integrated All-in-One Lab Partner for Multinational Clinical TrialsAs global clinical pipelines continue to expand in complexity, biopharmaceutical companies face rising demands for reliable, high-quality, and scientifically aligned clinical sample analysis across multiple regions. Many sponsors now seek central lab partners capable of unifying workflows that traditionally operate in silos, from kit production to bioanalysis and data reporting. GCCL, strategically based in Korea, has emerged as a preferred Asia-Pacific (APAC) hub for multinational trials by offering a fully integrated approach to clinical sample analysis that connects central lab operations, bioanalysis, R&D-driven method development, and controlled logistics within a single unified system.With experience supporting more than 1,200 clinical projects since 2019 and managing over 34,000 vials each month, GCCL has become a trusted analytical partner for global drug development programs seeking consistency, scientific depth, and operational reliability.Integrated Lab Operations Built for Global TrialsGCCL’s all-in-one model is designed to consolidate functions that are often divided across multiple vendors in multinational studies. The central laboratory supports full clinical safety testing and sample management for all clinical phases, offering comprehensive diagnostic coverage for global trials. The bioanalytical laboratory specializes in PK/PD, ADA, NAb, and biomarker analysis, utilizing advanced platforms such as LBA, LC-MS/MS, and ddPCR. GCCL also operates a BSL-3 facility that enables high-risk infectious disease studies, including PRNT/FRNT and specialized virology assays.All of these services function within a coordinated system, ensuring that sample handling, analysis, and reporting adhere to consistent standard operating procedures (SOPs) across all study regions. This unified framework enables sponsors to minimize variability, shorten timelines, and maintain a single source of truth for trial data across the APAC, North America, and Europe.R&D-Backed Scientific Expertise for Next-Generation ModalitiesGCCL’s R&D Lab strengthens its service model by providing targeted, study-specific scientific support. Lab experts develop and validate customized assays that reflect the biology of each therapeutic modality, from CNS biomarkers to oncology endpoints and metabolic disease markers. Recent collaborations include CNS biomarker method development for neurodegenerative disease programs, highlighting GCCL’s capacity to support emerging therapeutic areas with targeted scientific rigor.Unlike laboratories that provide standardized menus, GCCL emphasizes tailored scientific consultation. Lab experts work directly with sponsors from early-stage planning through database lock, helping refine assay design, sample requirements, technology selection, and biomarker strategy aligned with regulatory expectations. This close and continuous scientific involvement is often cited by sponsors as a key differentiator from large, compartmentalized global labs.Recent R&D achievements include CNS biomarker method development for neurodegenerative disease programs and analytical advances supporting biosimilar, infectious disease, and gene-therapy-related studies.Controlled Kit Production and Bio-Logistics That Protect Sample IntegrityPre-analytical variation is one of the biggest risks in multinational clinical trials. To address this, GCCL manages its own kit production based on protocol-specific requirements and oversees outbound and inbound logistics using validated bio-logistics processes. This includes a nationwide cold-chain network with dedicated drivers and partnership with verified global shipping vendors.These capabilities decrease variability in sample collection and transportation, ensuring that the biological integrity is maintained from the collection site to the laboratory. The system is further enhanced by G-HUB, GCCL’s integrated IT platform for study setup, kit tracking, sample status visibility, and laboratory data review. With real-time sample tracking and centralized oversight, sponsors gain transparency throughout the entire workflow. This level of control reduces delays, minimizes sample loss, and ensures consistency across all participating regions.Consistent Quality Aligned With International StandardsGCCL’s operations are built on globally recognized clinical quality frameworks. Its GCLP-certified laboratories maintain strict quality control, traceability, and audit-ready documentation that meet FDA, EMA, and ICH M10 expectations. The combination of validated platforms, unified workflows, and cross-functional alignment ensures that analytical outputs remain consistent across study phases, endpoints, and regions.With more than 200 method validation and analysis cases across PK/PD, ADA, and NAb studies, GCCL has demonstrated proficiency in delivering compliant, regulator-ready data for both early-phase programs and late-phase global trials.Analytical Expertise Across Therapeutic AreasGCCL offers specialized analytical support across a variety of therapeutic areas, including oncology, central nervous system (CNS) diseases, infectious diseases, metabolic disorders such as metabolic dysfunction-associated steatohepatitis (MASH) and obesity, biosimilars, antibody-drug conjugates (ADCs), as well as cell and gene therapies. For each indication, GCCL utilizes appropriate analytical techniques and develops customized methods supported by advanced technology and clinical trial experience. GCCL also has a strong capability in infectious diseases, backed by a BSL-3 facility and advanced molecular platforms that enable it to meet global demands for virology and pathogen analysis.This extensive expertise allows sponsors to consolidate multiple analytical endpoints with a single partner, thereby reducing operational complexity and accelerating decision-making.A Strategic APAC Hub Built for Speed and ConnectivityStrategically located near Seoul, Korea, GCCL benefits from the region’s strong clinical research ecosystem, rapid patient recruitment environment, and proximity to CROs, hospitals, and pharmaceutical hubs. With streamlined logistics through major international airports, GCCL ensures fast and reliable sample transport across borders.This environment has made Korea a preferred destination for global sponsors using Dual-Region Trial Setups, where early-phase studies are conducted in the US or Europe and patient enrollment and cost-efficient bioanalysis are executed in Korea. Through this model, GCCL helps sponsors accelerate timelines, optimize budgets, and maintain scientific and operational consistency across regions.Leveraging integrated operations, deep laboratory expertise, and experience managing thousands of sample shipments each month, GCCL provides sponsors with the reliability and scalability required for high-quality, multi-region clinical execution.Advancing Global Clinical Research With Integrated Lab SolutionsAs modern drug development increasingly depends on harmonized analytical systems capable of supporting complex modalities, GCCL continues to strengthen its position as a global clinical sample analysis CRO. Its unified central lab, bioanalytical capabilities, R&D-driven method development, controlled kit production, and validated logistics create a complete infrastructure designed to minimize variability and maximize scientific reliability.With proven execution across more than 1,200 studies and a commitment to providing tailored, regulator-aligned analytical solutions, GCCL offers global sponsors the consistency, speed, and scientific depth required to advance innovative therapeutics across North America, Europe, and APAC.

2025. 10. 30

GCCL Highlights the Rise of “K-Lab,” Sets Its Sights Beyond Korea to the Global Stage

GCCL Highlights the Rise of “K-Lab,” Sets Its Sights Beyond Korea to the Global Stage| Interview | Choi Yu-hwa, Head of Business Operations, GCCLKorea’s No.1 Clinical Sample Analysis Provider Joins KoNECT Korean Delegation“More Efficiently Positioned Than Singapore… Aiming to Become Asia’s Leading Lab”[Berlin | ESMO 2025 – Reported by Byung-woo Hwang] GCCL, a leading Korean clinical sample analysis company, showcased its competitiveness on the global stage at the European Society for Medical Oncology (ESMO 2025).Participating as part of the Korean delegation organized by the Korea National Enterprise for Clinical Trials (KoNECT), GCCL is actively expanding its presence beyond the domestic market and into international territories.“One of the most memorable reactions we heard at ESMO 2025 was, ‘We didn’t know there was such a high-level analytical lab in Korea,’” said Choi Yu-hwa, Head of Business Operations at GCCL, in an interview with DailyPharm. “We wanted to demonstrate that global clinical sample analysis can be performed not only in Singapore or Europe, but also in Korea.”“Korea’s Leading Clinical Sample Analysis Lab Begins Its Global Challenge”▲ Choi Yu-hwa, Head of Business Operations, GCCLGCCL is a specialized clinical sample analysis company under the Green Cross Holdings group and currently holds the No.1 market share in Korea’s clinical sample analysis sector.The company provides PK (pharmacokinetics), PD (pharmacodynamics), ADA, biomarker analysis, and central laboratory services across all phases of clinical trials, from Phase 1 through Phase 4.In particular, GCCL operates a dedicated bioanalytical laboratory, supporting early-phase trials with drug concentration and metabolism data, and late-phase trials with large-scale quantitative and qualitative patient data management. All analytical outputs are delivered in compliance with global regulatory standards.“Within Korea, GCCL is unquestionably the leading lab CRO in terms of technology, infrastructure, and talent,” Choi said. “Now, our goal is to expand into overseas sample analysis and establish GCCL as a central player in global clinical trials.”The company has already been building global awareness through continuous participation in major international conferences, including BIO Europe, ASCO, and BIO USA.“Earlier this year, we often heard people ask, ‘Why did you come all the way from Korea?’” Choi noted. “Now, as we meet the same industry professionals repeatedly at different events, more people recognize GCCL and are familiar with our capabilities.”Choi identified GCCL’s core strengths as technical expertise, geopolitical positioning, and experience gained during the COVID-19 pandemic.“Korea is known for its highly skilled technicians and exceptional technical precision,” she explained. “In clinical sample analysis, this level of craftsmanship directly translates into quality. During the COVID-19 pandemic, GCCL handled more than 30% of the sample analysis for government- and industry-led vaccine and therapeutic development projects, which significantly strengthened our R&D-driven analytical capabilities.”She also highlighted Korea’s strategic geographic location as a key advantage.“Korea is even more efficient than Singapore in terms of logistics,” Choi said. “It is ideally positioned as a hub connecting samples from Europe and North America to Asia.”Looking ahead, Choi emphasized GCCL’s long-term vision. “Our immediate goal is to establish ourselves as Asia’s representative lab CRO, and in the long run, to expand into the U.S. and European markets,” she said. “We will continue to prove that Korea is home to world-class clinical sample analysis laboratories.”Source: DailyPharm, reported by Byung-woo Hwang (https://www.dailypharm.com/Users/News/NewsView.html?ID=327934&REFERER=NP)*This article is a direct translation of an original Korean-language article prepared by GCCL.

2025. 10. 23

GCCL Targets Global Expansion, Differentiates Through Advanced Clinical Sample Analysis

GCCL Targets Global Expansion, Differentiates Through Advanced Clinical Sample Analysis[On-site Interview] Choi Yu-hwa, Head of Business Operations: “Developing Demand-Driven Assays for CNS and Beyond”GCCL, a clinical trial sample analysis company under the GC Group, is accelerating its global CRO strategy by leveraging its strong R&D capabilities in assay development. While reinforcing its position in the Asia market—traditionally centered around Singapore—the company is also stepping up efforts to expand into Western markets.The Bell met with Choi Yoo-hwa, Head of Business Operations at GCCL, to discuss the company’s global expansion strategy and recent achievements in analytical method development. Choi also serves as a member of the R&D Expert Committee under Korea’s Food and Drug Safety Regulatory Science Innovation Committee, an advisory body to the Ministry of Food and Drug Safety (MFDS).◇ IR Pitching and Networking Events Target Potential ClientsGCCL participated in BioPlus-Interphex Korea (BIX 2025) with a dedicated exhibition booth, introducing visitors to its differentiated central laboratory services and R&D-driven analytical capabilities.BIX 2025, hosted by the Korea Biotechnology Industry Organization (KoreaBIO) and organized by RX Korea, was held at COEX in Seoul from October 15 to 17. The event featured exhibitions, conferences, and partnering meetings designed to promote collaboration among domestic and international biotech companies.At this year’s event, GCCL placed a strong focus on engaging potential clients. In addition to operating its booth, the company hosted separate IR pitching and networking sessions for professionals from the pharmaceutical and investment communities. The goal was not only to promote GCCL’s services, but also to contribute to the broader growth of the biotech ecosystem.“We wanted to create an opportunity for biotech startups facing funding challenges to connect with potential investors,” Choi explained. “Despite the difficult industry environment, we were able to organize this event thanks to the strong support of the GC Group.”Founded in 2019, GCCL was established as a spin-off of the clinical trial analysis division of the Green Cross Medical Foundation. GC LabCell initially held a stake in the company, and following its merger into GC Cell in 2021, GCCL became a subsidiary of GC Cell. More than 20 years of accumulated sample analysis expertise from the Green Cross Medical Foundation now form the foundation of GCCL’s competitiveness.GC Cell currently holds a 65.45% stake in GCCL as the largest shareholder, followed by C&R Research with 25.57%. The Green Cross Medical Foundation also retains a 4.35% stake.Among CROs, GCCL places particular emphasis on its role as a central laboratory. In multicenter clinical trials, central labs integrate and analyze samples collected from multiple hospitals, ensuring consistency and reliability in analytical results and ultimately improving the credibility of clinical trial outcomes.◇ Differentiation Through R&D Lab Services: CNS and Cell Therapy Assay DevelopmentGCCL’s core competitive strength lies in its R&D laboratory services. While many central labs focus primarily on routine chemistry and hematology tests, GCCL has expanded its scope to include biomarker discovery, assay development, and validation. The company supports pharmaceutical sponsors across the entire development continuum—from biomarker identification in early research to late-stage clinical trials.“Traditionally, central labs paid limited attention to R&D,” Choi noted. “However, during the COVID-19 pandemic, central lab functions became essential for vaccine and therapeutic development. That period allowed us to accumulate significant R&D experience.”GCCL places particular emphasis on customized assay development in close collaboration with clients. In the first half of 2025, the company completed the development of analytical methods for cell therapies and CNS disease biomarkers. A representative example is the joint development of a biomarker assay with Curebus, a Korean biotech company developing novel treatments for Alzheimer’s disease.GCCL has also entered into a collaboration agreement with a major domestic pharmaceutical company to support a late-stage immuno-oncology clinical trial using a proprietary neutralizing antibody assay developed in-house.“Developing biomarker assays for Alzheimer’s disease and Parkinson’s disease is highly challenging,” Choi said. “By co-developing CNS biomarker assays with our clients, we successfully completed method development and published joint academic papers. More recently, we signed an MOU with Seoul National University’s Center for Neuropsychiatric Disease Evaluation, expanding our research scope from clinical to non-clinical stages.”Currently holding the No. 1 market share in Korea’s central lab CRO sector, GCCL’s next objective is global expansion. The company aims to firmly establish itself as a leading player in Asia while steadily extending its footprint into Western markets.Historically, Singapore has served as the hub of the Asian central lab market. However, GCCL believes that Korea’s precision technologies and analytical expertise are fully competitive on a global level, and is positioning itself to help reshape the regional market landscape.One remaining challenge is expanding experience in multinational clinical trials. While GCCL has extensive experience in domestic sample analysis, its exposure to multi-country trials remains relatively limited. To address this, the company plans to establish strategic partnerships with overseas CROs, laboratories, and clinical trial partners, positioning itself as a coordinating hub that provides integrated services across regions.“This year, we were recognized by Frost & Sullivan as a key provider of bioanalytical services in the Asia-Pacific region,” Choi said. “This recognition signifies that GCCL has entered the top tier in APAC. While Singapore has long been considered the center of the Asian central lab market, we want to demonstrate that GCCL can represent Asia as a leading central laboratory.”Source: The Bell, reported by Kim Chan-hyuk - https://www.thebell.co.kr/free/content/ArticleView.asp?key=202510161121309160108581 *This article is a direct translation of an original Korean-language article prepared by GCCL.

2025. 09. 24

[PR] GCCL and Frontage Laboratories Announce Strategic Collaboration

GCCL and Frontage Laboratories Announce Strategic Collaboration to Strengthen Global Clinical Trial Capabilities[September 24, 2025] GCCL (Global Clinical Central Lab), a South Korea-based leading provider of clinical trial sample analysis, and Frontage Laboratories, Inc., a USA based full-service contract research organization (CRO), announced on September 23 that they had signed a strategic Memorandum of Understanding (MOU) pursuant to which they intend to explore ways to strengthen their presence in the global clinical trial market.In signing the MOU, GCCL and Frontage intend to consider opportunities to leverage the complementary services and networks of both companies to enhance competitiveness, particularly in the United States and Asia-Pacific (APAC) regions, while driving mutual growth. In particular, during the signing ceremony, the two companies reaffirmed their commitment to collaboration and discussed opportunities for cooperation including joint clinical trial services in the U.S.A. and APAC regions, co-marketing and project support initiatives, development of new business opportunities, and additional initiatives.In addition, GCCL and Frontage will combine their respective regional expertise and global networks to collaborate in executing clinical trial projects while increasing efficiency and differentiation of services for clients worldwide. In doing so, GCCL would expect to further strengthen its global capabilities, while Frontage would look to bolster its clinical trial support system in the APAC region.“Through this MOU, Frontage is hoping to develop a relationship with GCCL with the goal of reinforcing its presence in the APAC market and work closely with GCCL to providing faster and more efficient support for global clinical trials,” said Dr. Nan Zhang, MD. PhD., Senior Vice President of Frontage. “By finding paths to collaborate and leverage the expertise and client networks of both companies, we would hope to further enhance the global clinical trial ecosystem and deliver high-quality, trusted services to our customers.” KwanGoo Cho, CEO of GCCL, added, “We are hoping to develop a strategic relationship with Frontage focused on a spirit of collaboration. By working together, GCCL’s bioanalytical and central lab expertise in APAC and Frontage’s global capabilities may create new growth opportunities in the global clinical trial market for both companies. As always, we continue to aim to set a new standard in clinical trial execution and deliver meaningful analytical outcomes to our clients.”About GCCL (Global Clinical Central Lab)GCCL, a subsidiary of the GC Group, is a leading clinical trial sample analysis provider offering an integrated “one-stop lab solution” with central, bioanalysis, and BSL-3 labs under one system. With tailored solutions, GCCL delivers precise and efficient analytical services across all phases of clinical trials, solidifying its position as a trusted partner in new drug development. Leveraging advanced platforms and LIMS, the company supports partners across Asia and beyond with customized and compliant solutions. In recognition of its leadership, GCCL recently received Frost & Sullivan’s 2025 Best Practices Customer Value Leadership Award in the Asia-Pacific clinical sample analysis services industry. For more details, visit: www.eng.gccl.co.kr.About Frontage Laboratories, Inc.Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions. For more details, visit: www.frontagelab.com.

2025. 09. 22

[PR] GCCL Signs MOU with Seoul National University’s Research Center (CLEVERcns)

GCCL Signs MOU with Seoul National University’s Research Center for Neuro-Psychiatric Disorder to Strengthen Collaboration in Clinical Research▶ Strategic partnership to advance clinical research in neuropsychiatric disorders, expand domestic and international infrastructure, and enhance global competitivenessGlobal clinical trial sample analysis organization GCCL (Global Clinical Central Lab, CEO KwanGoo Cho) announced on September 22 that it signed a Memorandum of Understanding (MOU) on September 19 with the Research Center for Neuro-Psychiatric Disorder of Seoul National University (CLEVERcns, Director Ki-Jeong Cheon) to promote mutual collaboration in clinical research on neuropsychiatric disorders and contribute to the development of the pharmaceutical industry.The MOU signing ceremony was attended by key representatives from both organizations, including CEO Kwan-Gu Cho of GCCL and Director Ki-Jeong Cheon of CLEVERcns. The parties reaffirmed their commitment to enhancing the quality of domestic neuropsychiatric clinical trials, expanding infrastructure for CNS clinical trial sample analysis, and strengthening global competitiveness.Key areas of collaboration outlined in the MOU include: ▲ Strengthening preclinical-to-clinical linkages in brain disease research, ▲ Joint development of CNS disease biomarkers and analytical methods, ▲ Collaborative operation of educational programs and exchange of technical and academic information, ▲ Joint promotion and support for “end-to-end CNS projects” and cooperation in global expansion, ▲ Sharing and utilization of domestic and international networks, infrastructure, and resources, ▲ Other areas of mutual interest as needed.CLEVERcns, a Seoul National University Hospital-affiliated center, leverages the hospital’s and university’s facilities and research infrastructure to support new drug development in neuropsychiatric disorders, providing clinical consultation and efficacy evaluation services. GCCL provides comprehensive clinical trial sample analysis services for the field and is a leader in developing CNS disease biomarkers and analytical methods.Through this collaboration, GCCL and CLEVERcns aim to generate more precise and reliable research data while providing end-to-end support from preclinical to clinical research for brain and CNS disorder studies.Director Ki-Jeong Cheon of CLEVERcns stated, “Research in neuropsychiatric disorders is highly complex and challenging, and obtaining high-quality clinical trial data is critical to the success of drug development. Through this MOU, domestic pharmaceutical and biotech companies, as well as researchers, will be able to utilize a world-class CNS clinical research environment more efficiently, contributing to the global recognition of Korea’s CNS research capabilities.”CEO KwanGoo Cho of GCCL added, “GCCL supports clinical trial success for domestic and international pharmaceutical and biotech companies by providing state-of-the-art analytical platforms and high-quality analytical services in CNS research. Our strategic collaboration with CLEVERcns represents an important step in strengthening the overall CNS research ecosystem. We will continue to prioritize data reliability and analytical quality while offering differentiated clinical trial sample analysis services in the global market.”GCCL is a fully GCLP-certified (Good Clinical Laboratory Practice) clinical trial sample analysis organization in Korea, providing tailored clinical analysis services that meet global standards across all phases of clinical trials, from Phase 1 to Phase 4. With advanced analytical platforms, including ddPCR instruments, and specialized sample analysis and method development services, GCCL supports domestic pharmaceutical and biotech companies as well as partners throughout Asia and worldwide.

2025. 09. 18

[PR] GCCL Announces Exclusive Booth and IR Networking Event at BIX 2025

GCCL (Global Clinical Central Lab) announced on September 18 that it will participate with an exclusive booth at Korea’s largest bio convention, BioPlus-InterPhex Korea 2025 (BIX 2025), held at COEX from October 15 to 17. On October 16, GCCL will also host a standalone IR Pitching & Networking Event.Organized by the Korea Bio, BIX 2025 will feature keynote speeches, professional sessions, exhibitions, partnering meetings, and receptions. This year, 300 companies from 15 countries are expected to participate, with over 550 booths—the largest scale in the event’s history.On the second day of the event, Thursday, October 16 at 4:00 PM, GCCL will host the “IR Pitching & Networking Event with GCCL” at Studio 159, 2nd floor, COEX. The event will bring together around 100 participants, including domestic and international pharma and biotech companies as well as investors, offering an opportunity to explore innovative technologies, business models, and potential strategic partnerships. The event will feature IR presentations from pharma and biotech companies along with open networking, and registration for participation is currently open.During the exhibition, GCCL will operate a large exclusive booth to introduce its all-in-one solutions encompassing Central Lab, Bioanalysis, and R&D for global clinical trial sample analysis. Leveraging extensive experience collaborating with domestic and international drug developers, GCCL will highlight its strengths in providing a reliable, integrated analysis service covering sample transportation, analysis, and data management.Notably, GCCL will present a new interactive lab tour using touchscreens, enabling visitors to intuitively experience GCCL’s analysis processes and services. With full GCLP (Good Clinical Laboratory Practice) certification, advanced analytical equipment, and optimized IT systems, GCCL emphasizes its competitive capabilities based on international quality standards, further strengthening its differentiated positioning and expertise in the global clinical trial market.CEO KwanGoo Cho stated, “BIX 2025 provides a significant platform to directly engage with the global pharma and biotech community and showcase GCCL’s expertise and integrated analysis solutions. Through the IR Pitching & Networking Event, we aim to expand strategic partnerships with domestic and international companies and further enhance GCCL’s global competitiveness in clinical trial sample analysis.”GCCL is a clinical trial sample analysis organization certified across all areas of the Ministry of Food and Drug Safety’s GCLP standards, offering tailored clinical analysis services that meet global standards for all phases of clinical trials, from Phase I to Phase IV. Leveraging diverse analytical platforms and professional sample analysis and method development services compliant with global quality standards, including ddPCR systems, GCCL supports clinical trial sample analysis for domestic pharma and biotech companies as well as partners across Asia and worldwide.

2025. 07. 30

[PR] GCCL Signs MOU with KoNECT to Foster Mutual Collaboration in Clinical Research

GCCL Signs MOU with KoNECT to Foster Mutual Collaboration in Clinical Research▶ Strategic agreement aims to enhance clinical sample analysis quality and facilitate technology exchangeGlobal clinical sample analysis organization GCCL (Global Clinical Central Lab, CEO Kwan-Goo Cho) announced on July 30 that it has signed a Memorandum of Understanding (MOU) with the Korea National Enterprise for Clinical Trials (KoNECT, President In-Seok Park) to promote mutual collaboration in clinical research and support the development of Korea’s pharmaceutical industry.The signing ceremony took place at GCCL headquarters on July 29, with key representatives from both organizations—including KoNECT President In-Seok Park and GCCL CEO Kwan-Goo Cho—in attendance. Both parties expressed a strong commitment to advancing Korea’s clinical trial ecosystem and accelerating new drug development through collaborative efforts. This agreement lays the groundwork for enhancing the quality of clinical sample analysis in Korea while building a foundation for policy and technological cooperation to improve global competitiveness.Key areas of cooperation under the MOU include:- Establishing institutional frameworks and policy collaboration to strengthen clinical sample analysis capabilities- Sharing up-to-date medical and clinical insights related to sample analysis and other key topics- Co-developing training and educational programs and promoting academic and technical exchanges- Collaborating on domestic and international promotion by leveraging each other’s networks and infrastructure- Exploring additional areas of mutual interestThis MOU is especially meaningful as it represents a strategic collaboration between a government-backed clinical trial support institution and one of Korea’s leading central labs specializing in clinical sample analysis. Both parties aim to jointly develop institutional foundations and implement practical initiatives to elevate Korea’s clinical trial capabilities and enhance its global competitiveness in new drug development.President In-Seok Park of KoNECT remarked, “This agreement marks a significant milestone in building a practical collaboration model that links policy with field expertise. We will continue to work closely with industry stakeholders to enhance clinical trial quality and strengthen the global competitiveness of Korea’s biopharmaceutical sector.”GCCL CEO Kwan-Goo Cho added, “We are honored to partner with KoNECT to raise the standards of clinical sample analysis and support the global advancement of Korea’s pharmaceutical and biotech industries. Leveraging our world-class analytical capabilities, we will continue to expand strategic partnerships with public institutions and deliver differentiated sample analysis services to global markets.”GCCL is a GCLP (Good Clinical Laboratory Practice)–certified central lab that provides tailored clinical sample analysis services aligned with global standards across all clinical phases, from Phase I to Phase IV. With advanced platforms including digital PCR (ddPCR), GCCL supports clients across Korea, the broader Asia-Pacific region, and worldwide by offering high-quality bioanalytical services and method development capabilities.

2025. 06. 27

[PR] GCCL advance Alzheimer’s R&D with new MAO-B biomarker assay for NeuroBiogen

GCCL advance Alzheimer’s R&D with new MAO-B biomarker assay for NeuroBiogenGCCL (Global Clinical Central Lab) said Thursday it established an assay for monoamine oxidase B (MAO-B), a central nervous system (CNS) disease biomarker, under a contract research agreement with NeuroBiogen.MAO-B is an enzyme that breaks down monoamines such as dopamine and is known to regulate neurotransmitter levels. MAO-B inhibitors are currently used to treat Parkinson's disease.NeuroBiogen’s phase 2a clinical trial -- funded by GCCL -- is a randomized, double-blind, placebo-controlled, and dose-exploratory study designed to evaluate the efficacy and safety of KDS2010 in patients with Alzheimer’s disease and mild Alzheimer’s disease dementia at the mild cognitive impairment stage.Tisolagiline (project name: KDS2010), being developed by NeuroBiogen, is a reversible and selective MAO-B inhibitor designed to overcome the limitations of existing drugs in maintaining long-term therapeutic efficacy. For this trial, GCCL has developed and validated an assay to detect MAO-B in clinical samples.According to GCCL, the assay has been optimized to reliably isolate MAO-B from platelet-rich plasma (PRP) in blood and to accurately measure its activity. Compared to existing methods, the new assay can clearly differentiate MAO-B levels between Alzheimer’s patients and individuals without the disease. It is also expected to be used in the future to evaluate MAO-B inhibitor effectiveness and to support diagnosis and research of CNS diseases.“Previous assays have been limited in studying MAO-B inhibitors due to low measurable activity levels or the difficulty in distinguishing activity differences between healthy individuals and Alzheimer’s patients,” said Dr. Hyun Jae-wook, who leads the research team at GCCL. “With this new assay, we can identify elevated MAO-B activity in Alzheimer’s patients and determine the degree of significant inhibition achieved through the drug’s mechanism.”The company believes the MAO-B assay identified in Alzheimer’s patients could be extended to other CNS diseases such as Parkinson’s, depression, and dementia.“Tisolagiline is an innovative drug candidate with structural differentiation that targets MAO-B and is expected to offer a new paradigm for Alzheimer’s treatment,” said Kim Sang-wook, CEO of NeuroBiogen. “Our collaboration with GCCL in this clinical development process has strengthened the scientific foundation of our core pipeline, tisolagiline, through high-precision, biomarker-based assays.”GCCL CEO Cho Kwan-goo added that the development of the MAO-B assay was the result of fully leveraging the company’s clinical analytics platform and expertise. “We will continue to actively support drug development companies in designing precise and efficient clinical strategies based on advanced biomarker analysis technologies,” he said.*Links: GCCL, NeuroBiogen advance Alzheimer’s R&D with new MAO-B biomarker assay (Korea biomedical Review, https://www.koreabiomed.com/news/articleView.html?idxno=28029)

2025. 05. 15

[PR] GCCL and MediRama sign MOU for strategic collaboration in clinical trial services

- Integrating the expertise and capabilities of both companies for efficient clinical trial solutions(From the left) Moon Hanlim, CEO of MediRama, and Cho Kwan-goo, CEO of GCCL (Source: GCCL)GCCL, a global clinical trial sample analysis agency, announced on May 13 that it entered into a memorandum of understanding (MOU) with MediRama on May 12, aimed at fostering mutual cooperation in clinical trial services.The signing ceremony, held at MediRama’s headquarters, was attended by key representatives from both companies, including MediRama CEO Moon Hanlim and GCCL CEO Cho Kwan-goo. During the event, the two companies reaffirmed their commitment to collaboration, discussing the direction of potential cooperation in various areas, including clinical trial services, technology exchange, and joint business planning. Additionally, they emphasized their shared intention to support Korean and international novel drug developers throughout the entire clinical development process, from strategic planning to the generation of analytical data.The key contents of the business agreement include joint cooperation in clinical service businesses for novel drug development, cooperation in the consignment and execution of domestic and international clinical trial services, planning and marketing of joint business initiatives, mutual exchange of technological and academic information, and other areas of mutual interest based on the needs of both parties.GCCL and MediRama anticipate that by combining their respective strengths and expertise in the clinical trial service sector, they will enhance their competitiveness in both Korean and global clinical development markets, generating synergy for more rapid and precise clinical outcomes. In particular, the integration of MediRama’s strategic clinical development know-how and GCCL’s specialized capabilities in precise sample analysis is expected to provide more efficient clinical trial solutions to their clients.“With this agreement, we expect to create a more stable and efficient clinical development environment by effectively integrating the strengths of both companies,” said Moon Hanlim, CEO of MediRama. “We will maintain close collaboration with GCCL to further strengthen our competitiveness in the domestic and international clinical trial markets,” she added.“Establishing a cooperative model with MediRama that supports the entire new drug development cycle based on precise and reliable analysis services is meaningful,” expressed Cho Kwan-goo, CEO of GCCL. “Through this agreement, we aim to maximize mutual synergy and set a new benchmark for delivering faster and more reliable clinical services to the clients of both companies.”Founded in 2021, MediRama is a clinical development company recognized for its expertise in anticancer drug development. The company currently operates its proprietary ‘ABCD (Advanced Business Model for Clinical Development) platform,’ a comprehensive one-stop solution that efficiently supports the entire clinical trial process. This platform covers all aspects of clinical development, from strategy formulation and trial execution to issue resolution and real-time response management, providing rapid and precise support throughout the development cycle. MediRama currently serves as the clinical development headquarters for various biotechnology companies, supporting their successful clinical development.GCCL is a clinical trial specimen analysis institution certified in all fields of Good Clinical Laboratory Practice (GCLP) by the Ministry of Food and Drug Safety. The company provides tailored clinical analysis services throughout the entire clinical trial cycle, from Phase 1 to Phase 4, aligning with global standards. Leveraging a range of analytical platforms, including the introduction of ddPCR devices, and offering specialized specimen analysis and method development services, GCCL supports clinical trial specimen analysis needs for Korean pharmaceutical and biotech companies, as well as partners across the Asian region and around the world.*Links: The BIO, Yu, Suin, GCCL and MediRama sign MOU for strategic collaboration in clinical trial services

2025. 02. 18

[PR] GCCL Becomes First in Korea to Commercialize Parkinson’s Disease Biomarker Anal

GCCL Becomes First in Korea to Commercialize Parkinson’s Disease Biomarker Analysis for Clinical Samples- Supporting research and diagnosis of intractable neurodegenerative diseases through the commercialization of α-synuclein biomarker analysisGCCL (Global Clinical Central Lab), a clinical trial sample analysis organization led by CEO Kwan Koo Cho, announced on the 18th that it has successfully developed and commercialized a biomarker analysis method for α-synuclein (αSyn), a key biomarker for Parkinson’s disease—becoming the first in Korea to offer this service.Parkinson’s disease is a representative neurodegenerative disorder that causes motor dysfunction and cognitive decline. Abnormal aggregation of αSyn within neurons is considered one of the primary causes of the disease. In recent years, αSyn has also drawn attention for its role in a range of neurodegenerative diseases including Alzheimer’s disease. Accordingly, the Seed Amplification Assay (SAA), which enables detection of αSyn in bodily fluids, has emerged as an important diagnostic technology.The National Institute on Aging (NIA) and the Alzheimer’s Association (AA) in the U.S. recently included αSyn-SAA as a key biomarker in their updated diagnostic guidelines for Alzheimer’s disease, specifically for detection in cerebrospinal fluid (CSF). However, until now, this type of biomarker analysis service has not been available in Korea.GCCL has successfully developed and commercialized the αSyn-SAA assay in-house.The method, developed by GCCL’s R&D team led by Dr. Hyun Jae-Wook and Senior Researcher Min-Young Kim, enables detection of αSyn not only for Parkinson’s disease but also for other neurodegenerative diseases such as multiple system atrophy and dementia with Lewy bodies. It also shows potential for use in differential diagnosis of Alzheimer’s disease and other rare neurological conditions.Unlike conventional immunoassays that measure normal αSyn, this assay directly amplifies and detects abnormal αSyn in CSF, providing significantly more accurate insights into disease presence and progression. GCCL has validated the assay by confirming and verifying the detection of αSyn in both cerebrospinal fluid and brain homogenate samples used in CNS (central nervous system) disease research.With this advancement, pharmaceutical companies now have access to a highly sensitive and precise biomarker analysis platform to support neurodegenerative disease research and drug development.To share its findings, GCCL will present the research results in detail at a seminar hosted by the Seoul National University Hospital Center for Efficacy Assessment of Neuropsychiatric Disorders on March 26.CEO Kwan Koo Cho stated, “We expect this R&D achievement to significantly contribute to neurodegenerative disease research and drug development in Korea. Biomarker analysis with high accuracy is a critical success factor in CNS drug development, and GCCL will continue to lead the way in delivering global-standard clinical analysis services.”GCCL is a GCLP-certified clinical trial sample analysis organization recognized by the Korean Ministry of Food and Drug Safety. It offers customized clinical sample analysis services for all phases of clinical trials, from Phase I to IV, in accordance with global standards. By operating multiple analysis platforms—including ddPCR systems—and providing expert method development and bioanalytical services, GCCL supports pharmaceutical and biotech companies not only in Korea but also across Asia and globally.

2025. 02. 07

[PR] GCCL Wins 2025 Asia-Pacific Customer Value Leadership Award by Frost & Sullivan

- GCCL's "One-Stop Lab Solution" sets the industry benchmark with unmatched competitiveness and a dedication to global excellence.- Continuing its growth as a globally recognized leader in clinical sample analysis, driven by customer-centric values.YONGIN, South Korea, Feb. 7, 2025 /PRNewswire/ -- GCCL(Global Clinical Central Lab), a leading Korean clinical trial sample analysis company, reinforced its position in the global market by receiving Frost & Sullivan's 2025 Best Practices Customer Value Leadership Award in the Asia-Pacific clinical sample analysis services industry.Frost & Sullivan, a global-established growth consulting company, honors companies that demonstrate exceptional leadership, innovation, and performance through its annual Best Practices awards. The organizations excel in delivering outstanding value by assessing the market participants' value. Using a rigorous evaluation process, Frost & Sullivan assesses criteria including growth potential, customer acquisition, customer experience, operational efficiency, and equity. Having excelled in these areas, GCCL earned this recognition for its comprehensive services, customer-centric approach, and technological leadership.GCCL is one of the few clinical trial sample analysis service providers offering a "one-stop lab solution" that integrates central lab, bioanalysis lab, and BSL-3^[i] lab services into a single, unified system. This consolidated approach minimizes sample movement between facilities, reducing logistics time and costs while ensuring sample stability. As a result, it enhances data reliability and strengthens the credibility of study outcomes. By leveraging cutting-edge analytical platforms and implementing its Lab Information Management System (LIMS), GCCL maintains high standards in global clinical research. With tailored solutions, GCCL delivers precision and efficiency in clinical trials, solidifying its position as a trusted partner in new drug development.Frost & Sullivan highlighted GCCL's integrated lab service model, highlighted that systematic quality control and industry-leading technological innovation were as key factors in earning the award. This recognition underscores GCCL's leadership in the APAC region, showcasing its position as APAC's and unmatched capabilities in clinical sample analysis.Kwan-goo Cho, CEO of GCCL, stated, "The award is a global recognition of our efforts and achievements in prioritizing customer value and proof that GCCL has established itself as the solid leader in the market." He added, "We will continue to drive technological innovation and improve service quality to meet the rising demand in global clinical trials and to lead in the role as a trusted partner for new drug development."GCCL is a Good Clinical Laboratory Practice (GCLP)-certified lab accredited by the Ministry of Food and Drug Safety of South Korea. The company provides clinical trial sample analysis services globally across all clinical trial phases(I-IV), leveraging advanced analytical platforms including ddPCR technology, and its specialized expertise in sample analysis and method development. Serving pharmaceutical and biotechnology companies as well as in Korea, Asia, and beyond, GCCL is committed to deliver world-class, customized clinical trial solutions.^[i] Bio safety Level 3*Links: PR Newswire - GCCL Wins 2025 Asia-Pacific Customer Value Leadership Award by Frost & Sullivan (7 Feb, 2025)

2025. 01. 24

[PR] GCCL and Cureverse collaborate on Alzheimer's disease drug development in clinical trials

- Plans to support the entire process from test method development to mRNA analysis for Alzheimer's disease treatment developmentGCCL, a clinical trial sample analysis organization, revealed on January 24 that it has entered into an agreement with Cureverse to conduct a Phase 1 clinical trial for the company’s Alzheimer’s disease novel drug candidate, ‘CV-01 (development code name).’The clinical trial will focus on evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and the impact of food on the bioavailability of CV-01 following oral administration in healthy young adults and the elderly. GCCL will oversee the entire Central Lab process, including the development of assay methods and analyzing four types of messenger ribonucleic acid (mRNA) to explore pharmacodynamic characteristics. Additionally, it will involve sample management, including PBMC separation, and project management, using the cutting-edge analysis platform, ‘Droplet Digital Polymerase Chain Reaction (ddPCR) Device,’ for analysis throughout the trial.mRNA analysis plays a critical role in monitoring disease progression and assessing treatment efficacy by analyzing gene expression linked to the degeneration of specific nerve cells in neurological disorders such as Alzheimer’s disease. Due to its inherent instability, mRNA required sophisticated technology for precise analysis. For the CV-01 clinical trial, GCCL will conduct the analysis of four distinct mRNA types to support the trial’s investigation.CV-01, under development by Cureverse, is a novel drug candidate based on a small molecule compound aimed at treating Alzheimer's disease, Parkinson's disease, and epilepsy. It works by modulating the keap1/Nrf2 signaling pathway that regulates neuroinflammation. CV-01 is recognized for its superior metabolic stability compared to existing approved treatments and its strong efficacy in activating the Nrf2 pathway.Notably, CV-01 has been developed in an oral dosage form, in contrast to the traditional injectable treatments, which greatly enhances patient convenience. Recently, it secured a technology export agreement with the global pharmaceutical company Angelini Pharma.“At Alzheimer’s disease treatment development requires diverse strategies, CV-01 holds great potential to overcome the limitations of current treatments and deliver strong therapeutic effects,” said Cho Sung-jin, CEO of Cureverse. “We anticipate this collaboration to mark a key milestone in the development of novel drugs for Alzheimer’s disease.”“Partnering with Cureverse presents a valuable opportunity to demonstrate our company’s expertise in precision analysis,” expressed Cho Kwan-goo, CEO of GCCL. “We are committed to leveraging our advanced analysis technology and extensive experience to ensure the success of the clinical trials and contribute to the development of innovative Alzheimer’s disease treatments,” he added.Cureverse, founded in October 2021, specialized in the development of innovative novel drugs based on small molecules aimed at treating brain diseases. Established as a research institute company to commercialize technologies from the Korea Institute of Science and Technology (KIST), the company leverages the infrastructure and expertise of the KIST Brain Science Research Institute’s infrastructure and expertise to identify and develop promising drug candidates. Its mission is to offer new treatment options to patients around the world by discovering innovative drugs for neurological conditions.GCCL is a clinical trial specimen analysis institution that holds full certification in areas of the Ministry of Food and Drug Safety’s Good Clinical Laboratory Practice (GCLP). The company offers customized clinical analysis services that adhere to global standards throughout the entire clinical trial process, from Phase 1 to Phase 4. Leveraging advanced analysis platforms that meet global quality standards, including the introduction of ddPCR equipment, as well as specialized services in specimen analysis and method development, GCCL supports clinical trial specimen analysis not only for Korean pharmaceutical and biotechnology companies but also for partners in the Asian region and around the world.Source : [The Bio/Kang In Hyo] GCCL and Cureverse collaborate on Alzheimer's disease drug development in clinical trials (https://www.thebionews.net/news/articleView.html?idxno=12394)

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