International Clinical Trial Center Network
Newsletter

When international clinical research succeeds, the milestone is not simply enrolling the first participant—it is the trust, coordination, and shared commitment that make it possible.

On 18 June 2026, the Faculty of Medicine Siriraj Hospital, Mahidol University, became the first site outside Japan to enroll a participant in the ABLe Study, an international multicenter observational study investigating bloodstream infections caused by third-generation cephalosporin-resistant Escherichia coli and Klebsiella species. This milestone marked the launch of patient enrolment beyond Japan within the ARISE network and highlighted Thailand’s growing contribution to international clinical research.

For the Siriraj Institute of Clinical Research (SICRES), the achievement reflected years of investment in clinical research infrastructure, investigator training, quality management systems, and international partnerships.

Multinational research brings unique challenges, including differences in regulatory requirements, ethics review processes, operational procedures, and communication practices. Overcoming these challenges required early planning, transparent communication, continuous coordination, and mutual trust among participating institutions. Equally important was a shared commitment to the scientific objectives of the study, allowing partners to work beyond institutional differences toward a common goal.

The ABLe Study also demonstrates the importance of international collaboration in addressing antimicrobial resistance (AMR). No single country can fully understand the evolving epidemiology of resistant pathogens. By generating high-quality clinical data across diverse healthcare settings, international research networks can strengthen the global evidence base and support better patient care.

Perhaps the most important lesson is that successful global research is built on relationships. Scientific expertise must be supported by cultural understanding, respect for different regulatory and healthcare environments, and open communication.

As an academic clinical research institute, SICRES remains committed to strengthening international partnerships that advance clinical research, build research capacity, develop future leaders, and contribute to global health.

In clinical research, protocol amendments, site modifications, and real-time operational shifts occur daily. At MED BUU CRC, our experience revealed that relying on institutional SOPs designed for standard human research ethics often created procedural bottlenecks for clinical trials requiring rapid, dynamic adjustments. Standard operational flows were frequently too rigid to support the fast-paced compliance and monitoring demands of complex clinical trials.

To directly address this challenge, the Faculty of Medicine at Burapha University is taking proactive steps this year to establish a dedicated Faculty Institutional Review Board (IRB).

By decentralizing from generic institutional oversight and creating an IRB specifically tailored to medical and clinical research, we aim to:

• Streamline protocol review and amendment workflows.
• Develop tailored SOPs capable of accommodating real-time trial modifications.
• Maintain rigorous ethical standards and participant safety without compromising trial timelines.

Through this initiative, we look forward to fostering a more responsive research ecosystem that better supports researchers, sponsors, and global clinical trial collaborators.

As clinical research becomes increasingly global, collaboration across continents is essential to accelerate innovation and improve patient outcomes. However, multinational clinical trials and real-world evidence (RWE) studies often face challenges that extend beyond science alone.

One common barrier is regulatory and contractual complexity. Differences in indemnity, insurance, liability requirements, data protection regulations, and governing law can delay study start-up. Early engagement with sites, open communication, and a willingness to explore practical alternatives are often critical to reaching mutually acceptable solutions.

Another challenge is data harmonization in multinational RWE studies. Participating sites may use different electronic health record systems, coding terminologies, laboratory methods, and measurement units. Data completeness can also vary significantly between countries. Successful studies typically invest in early feasibility assessments, standardized data collection processes, targeted training, and continuous data quality monitoring.

Clinical and operational differences also play an important role. Standards of care, research infrastructure, staffing resources, and regulatory timelines can vary widely across regions. What is feasible in one country may not be practical in another. Understanding local capabilities early and adapting study operations accordingly can greatly improve execution.

Equally important are cultural and communication differences. Variations in communication styles, decision-making processes, and organizational culture can sometimes lead to misunderstandings or delays. Building trust, respecting local perspectives, and maintaining transparent communication are key to successful collaboration.

Key Lesson Learned
Successful intercontinental clinical trial collaboration is not about making every country work in the same way. It is about understanding and respecting differences while aligning around shared objectives. Organizations that succeed are those that engage stakeholders early, remain flexible, communicate openly, and develop solutions that balance local requirements with global study goals.

Ultimately, strong partnerships, mutual respect, and a collaborative mindset are the foundations for delivering high-quality international clinical research and improving patient outcomes worldwide.

The key challenges include differences in regulatory requirements across countries, as well as variations in the ethical review processes, required documentation, approval timelines, and reporting standards. These differences may lead to delays and increase the administrative and documentation burden on research sponsors and research teams.

Proposed Solutions: Plan and estimate the time required for document submission and the ethical review process in advance. In addition, ensure that all necessary documents are complete and comply with the requirements of each country. At the same time, the ethical review process is being accelerated and improved to address these challenges.

In December 2025, the U.S. Food and Drug Administration (U.S. FDA) approved zoliflodacin (NUZOLVENCE®), the first new antibiotic developed specifically for the treatment of gonorrhoea in decades. The approval marked a significant milestone in addressing antimicrobial resistance (AMR) and provided a much-needed treatment option for a disease that has become increasingly resistant to existing antibiotics.

SICRES is proud to have contributed to the global Phase III clinical trial supporting this landmark regulatory approval. The study enrolled 930 participants across 16 clinical sites in five countries spanning four continents, demonstrating how international collaboration can generate robust clinical evidence with global impact.

Large multinational trials require more than scientific expertise. They depend on harmonized procedures, consistent data quality, effective communication across time zones, and strong collaboration among investigators, sponsors, regulators, and research teams. Each participating site contributes not only participants but also local expertise, operational excellence, and a commitment to the highest standards of Good Clinical Practice.

The zoliflodacin programme also demonstrates the value of innovative public-private partnerships. By bringing together academic institutions, non-profit organizations, industry partners, and regulatory authorities, the project showed how diverse stakeholders can work collectively to address urgent global health challenges.

For the clinical research community, this achievement offers an important reminder: meaningful innovation rarely happens in isolation. Complex public health challenges require international networks that bring together diverse expertise, shared resources, and common goals.

As an academic clinical research institute in Thailand, SICRES is honored to contribute to research with the potential to improve health outcomes worldwide. Every successful multinational trial strengthens not only the evidence for new treatments, but also the partnerships and research capacity needed to advance future medical innovation.

On 17 July 2026, we hosted a webinar on the critical role of source documentation in safeguarding data integrity throughout the clinical research process. The 30-minute session was led by Ms Ada Chan, Assistant Managing Director of the HKU Clinical Trials Centre.

During the webinar, Ms Chan explained why reliable clinical trial data must begin with accurate, complete and well-maintained source documentation. She also discussed key documentation principles, common challenges encountered by research teams and practical strategies for strengthening documentation practices across clinical trial sites.

We thank Ms Chan for sharing her valuable expertise and all ICN members who joined the session.

On 11 September 2026, we hosted a webinar exploring the selection of clinical trial centers for allogeneic cell therapy studies. The session was led by Ms Sammi Hsu, Senior Manager and Corporate Spokesperson at Ever Supreme Bio Technology Co. Ltd., who shared insights from a sponsor’s perspective. Ms Hsu has extensive experience in cell and gene therapy, clinical development and regulatory submissions.

Ms Hsu highlighted that successful site selection requires more than relevant clinical experience. Sites must also have capable multidisciplinary teams, robust donor-management and traceability systems, and well-established processes for handling investigational cell therapy products.

Pharmacy readiness was another key consideration, particularly the availability of cryogenic storage, appropriate product-preparation facilities and reliable cold-chain management. Close coordination among clinical, pharmacy, nursing and research teams is equally important for supporting the safe and effective delivery of these complex studies.

We thank Ms Hsu for sharing her valuable expertise and all participants who joined the session.

The ICN Operations Team is expanding to keep pace with the growing scale and complexity of ICN's activities. This expansion strengthens day-to-day coordination and helps ensure that operational workflows, from planning and logistics to documentation and stakeholder support, continue to run smoothly.

The expanded team brings together colleagues from Clinical Trials Center, University of Zurich and University Hospital Zurich (CTC Zurich), Clinical Trials Centre, The University of Hong Kong (HKU-CTC), Institute for Advancement of Clinical and Translational Science, Kyoto University and Kyoto University Hospital (iACT Kyoto), Shanghai Clinical Research Center (SCRC), and Singapore Clinical Research Institute (SCRI). With this broader cross-organisation support, ICN operations will be better positioned to maintain continuity, improve responsiveness, and deliver consistently high-quality support across our network.

The Japan Ministry of Health, Labor and Welfare (MHLW) started the GCP public consultation from July 31 to August 30, 2026. Then MHLW will proceed to finalize the GCP with the comments/opinions received. The formal implementation is scheduled for April 1, 2027.

In January 2026, the NPRA issued the Directive for the Use of the Malaysian Guideline for Good Clinical Practice (GCP) Fifth Edition (2026), marking a significant update to national clinical research standards. The guideline officially came into effect on 1 April 2026 and was formally launched at the CRM Trial Connect 2026 Conference in Kuala Lumpur on 7 May 2026. This new edition reinforces Malaysia’s commitment to ethical integrity, regulatory compliance, and high‑quality clinical trial conduct.

Issuing Authority: National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia

Amended Good Clinical Practice (GCP) for Drugs will take effect in China on 1 September 2026. The National Medical Products Administration (NMPA) and relevant authorities have issued an updated GCP guideline to strengthen the conduct and oversight of drug clinical trials.

The revised guideline places greater emphasis on ethical review and informed consent to safeguard participants’ rights, safety and well-being. It also introduces a new chapter on data governance, clarifies the responsibilities of principal investigators, and strengthens oversight by ethics committees.

The Notification of the Ministry of Public Health on the Criteria, Procedures, and Conditions for Conducting Drug Trials for Marketing Authorization, B.E. 2566 (2023), which is enforced by the Thai Food and Drug Administration (Thai FDA), establishes the requirements and procedures for applying for permission to conduct drug trials, the documents required for submission, the validity period of the authorization, and the oversight of research sponsors. It also emphasizes that clinical research must be conducted in accordance with ICH-GCP standards. This notification represents an important update to Thailand’s regulatory framework for clinical trials, bringing it into greater alignment with international standards.

The Thai Food and Drug Administration (Thai FDA) has introduced key updates to Thailand's medical device regulatory landscape. Key developments include the new Medical Device Labeling Regulations (B.E. 2568), modernized electronic application pathways for device registration, and streamlined record-keeping/reporting criteria.

Crucially for clinical researchers, the Thai FDA's Medical Device Control Division published updated guidelines regarding the acceptance of Ethics Committees (IRBs/IECs) reviewing human clinical research projects for medical devices. This shift emphasizes standardized safety surveillance, clearer technical documentation assessments, and aligned post-market oversight.

(Issuing Authority: Thai FDA / Ministry of Public Health, Thailand)

More than 200 researchers, clinicians, regulatory representatives and experts gathered at the SCTO Symposium 2026, hosted by the Clinical Trials Center (CTC) of University Hospital Zurich (USZ), to discuss the opportunities and challenges of artificial intelligence in clinical research.

Under the theme “AI meets Clinical Research – Navigating regulatory, ethical and legal frontiers”, discussions covered AI in study design, data protection, ethics and regulatory requirements. The key message was clear: AI offers great potential, but its responsible use requires clear ethical, legal and regulatory frameworks.

The symposium provided valuable opportunities for interdisciplinary exchange and important impulses for the future of clinical research in Switzerland.

Currently studying and conducting a Phase III, multicenter, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of RO7790121 at the dose intended to induce disease remission in patients with moderately to severely active ulcerative colitis.

Additionally, conducting the “IMPACT of Nebilet in Blood Pressure Control in Patients with Hypertension: An Observational, Longitudinal Study.”

In the first half of 2026, the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo in Alessandria reached a historic milestone by being officially designated as an IRCCS (Scientific Institute for Research, Hospitalization and Healthcare) in the field of Cardiology and Pulmonology. This recognition, granted by the Italian Ministry of Health, makes our Institute the first public IRCCS in the Piedmont Region.

The designation is the result of a long-term collaborative effort involving the Ministry of Health, the Piedmont Region, the University of Eastern Piedmont, local healthcare institutions, researchers, clinicians, and the wider community. It also acknowledges decades of scientific excellence, particularly in research on asbestos-related diseases and malignant mesothelioma.

This achievement represents not only an important recognition but also a new starting point. It strengthens our commitment to high-quality clinical research, enhances the attractiveness of our institution for national and international collaborations, and expands opportunities for patients to access innovative research and advanced treatments.

The Clinical Investigation Centre (CIC), Universiti Malaya Medical Centre (UMMC) proudly marked a milestone year with recognition at CRM Trial Connect 2026. CIC was honored with the prestigious Study Site of the Year (Overall) award for the fifth consecutive year, underscoring its sustained excellence in clinical trial operations.

As a gold sponsor and exhibitor, CIC actively engaged with stakeholders through its booth, which served as a platform for networking, exploring future collaborations, and strengthening ties with sponsors and partners. This presence showcased CIC’s leadership in Malaysia’s clinical research ecosystem and reinforced its role as a hub for advancing high-quality, ethical, and impactful clinical trials.

The International Clinical Research Office (ICRO) at Kyoto University Hospital Institute for Advancement of Clinical and Translational Science (iACT) is dedicated to advancing global clinical research by facilitating overseas-initiated studies, supporting international expansion for hospital-led research, and strengthening infrastructure for collaborative studies. Led by Associate Professor Takao Kato alongside Dr. Elham Fakhrejahani, Dana Lin, and Makiko Watanabe, our team aims to enhance patient access to innovative medical technologies and accelerate global life science innovations. Please feel free to contact icro_iact@kuhp.kyoto-u.ac.jp if any inquiry.

In 2026, the University Hospital Zurich (USZ) has introduced new initiatives to strengthen training and onboarding for clinical research staff.

Since April, USZ has offered a GCP Refresher recognised by swissethics and aligned with ICH-E6(R3). The self-paced online course supports researchers in keeping their GCP knowledge up to date and adapting to the latest GCP requirements.

Since June, USZ has also introduced an enhanced “Clinical Research Onboarding @USZ” programme for new study staff. The two-hour session provides a practical introduction to key processes, requirements and responsibilities in clinical research at USZ, while also promoting networking and interdisciplinary exchange.

While these initiatives are primarily designed for researchers at USZ, we are pleased to share them with our ICN members as examples of how institutions can strengthen GCP training and support staff entering the clinical research environment.

Thailand’s ambition to become a regional clinical research hub took another step forward during the Thailand Research Expo 2026 on 22 June 2026, where SICRES participated in the forum, “Thailand Clinical Research Hub: Aligning Clinical Research Capacity with New Growth Engine Policy.”

The forum brought together representatives from government agencies, regulatory authorities, universities, hospitals, industry, and research organizations to explore how Thailand can strengthen its clinical research ecosystem and enhance competitiveness.

Key priorities included developing skilled clinical research professionals, strengthening infrastructure, streamlining regulatory processes, promoting international collaboration, and fostering partnerships among academia, healthcare institutions, industry, and policymakers.

For SICRES, the forum reaffirmed our commitment to strengthening Thailand’s clinical research capacity. As a clinical research institute under the Faculty of Medicine Siriraj Hospital, Mahidol University, we believe growth depends not only on individual research centers but also on a national ecosystem where knowledge, expertise, and best practices are shared.

The discussions highlighted the importance of collaboration. By investing in people, quality systems, innovation, and partnerships, Thailand can strengthen its capacity to conduct high-quality clinical trials and contribute to health research.

SICRES is proud to collaborate with national partners in shaping Thailand’s future as a trusted destination for clinical research and innovation.

The CTC is pleased to share a new publication, “Towards a clinical large language model: an ethico-legal case study analysis.” The publication was initiated by the CTC and examines the ethical, legal and organisational challenges of training clinical large language models (LLMs) using health data, based on a Swiss case study.

Key topics include data protection and security, informed consent and transparency. The paper also provides recommendations for researchers, ethics committees and policymakers on the responsible development and use of clinical LLMs.

Read the publication

Greater Bay Alliance of Clinical Trials Excellence (GBAct) was officially inaugurated at the 2026 DIA China Annual Meeting in Shanghai on 16 May 2026. HKU Clinical Trials Centre (HKU-CTC) is honoured to be among the founding members of this landmark alliance, which brings together 14 leading clinical trial institutions across 10 cities in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA).

Jointly led by Southern Medical University Nanfang Hospital and HKU-CTC, GBAct aims to foster a resource-sharing ecosystem and strengthen regional collaboration in clinical research. By leveraging collective expertise, infrastructure, and diverse patient populations, the alliance seeks to advance clinical trial excellence and accelerate the translation of innovative research into healthcare benefits for patients across the region.

Alongside the inauguration, HKU-CTC contributed to key discussions at DIA China, sharing insights on institutional capacity building, the strategic implementation of GBAct, and innovative approaches to clinical trial management and research ethics training.

In April 2026, HKU-CTC organised a three-week intensive training series, "ICH E6(R3) GCP Guideline in Action: From Clinical Trial Principles to On-site Practice." Comprising six dynamic sessions, the programme brought together clinical research professionals to explore the practical application of the updated guideline in daily clinical operations.

Drawing on their extensive experience in clinical research operations, HKU-CTC's team leads shared practical insights and implementation strategies to support participants in navigating the evolving regulatory landscape.

Key topics included quality by design and risk-proportionate approaches, strengthening source data documentation through ALCOA++ principles, safety reporting in complex trial environments, and best practices in investigational product and biospecimen management. Participants also gained insights into developing strategic quality management systems aligned with institutional objectives and conducting the informed consent process effectively and ethically.

The SCRI Clinical Trials Symposium 2026, themed “Clinical Trials Reimagined: Advancing Innovation, Inclusion and Impact,” brought together local and international leaders from healthcare, academia, government and industry to explore the future of clinical research.

A major milestone was the signing of three Memoranda of Understanding with eight public- and private-sector partners. These collaborations aim to strengthen patient and public involvement, expand access to innovative trials, streamline trial processes and reinforce Singapore’s position as a globally connected clinical research hub.

Discussions also highlighted the potential of emerging technologies, artificial intelligence and new therapeutic modalities. Patient and caregiver perspectives reinforced the importance of making clinical trials more inclusive, accessible and responsive to the needs of the communities they serve.

We look forward to building on the connections and shared commitment established at the Symposium as we work together to advance more innovative, inclusive and impactful clinical trials.

Learn more

On 20 May, HKU-CTC hosted a series of public engagement activities to celebrate International Clinical Trials Day, a global occasion honouring Scottish physician James Lind, who conducted the first documented clinical trial on scurvy on 20 May 1747.

This year's activities brought clinical research closer to the community through interactive game booths, educational exhibitions, and limited-edition souvenirs featuring our HKU-CTC Panda Ambassadors, offering participants an engaging way to explore the clinical trial journey and the role of research in advancing healthcare.

More than 500 participants joined the event, ranging from members of the public to research professionals across diverse specialties. The enthusiastic turnout and lively discussions highlighted growing public interest in clinical trials and the importance of community engagement in driving medical innovation.

This year, the Clinical Investigation Centre (CIC), Universiti Malaya Medical Centre (UMMC) celebrated International Clinical Trials Day during the CIC Appreciation High Tea 2026. A symbolic cake-cutting ceremony marked the occasion, bringing together investigators, study teams, and collaborators to honour their contributions to advancing clinical research.

The event also introduced CIC’s CIC90 approach, a new initiative designed to streamline clinical trial processes and strengthen efficiency in future studies. In addition, awards were presented to recognise outstanding achievements, including First Patient (Worldwide, Asia Pacific, Malaysia), Malaysia Top Recruiter, and Fulfilment of Patient Recruitment Targets within stipulated timelines.

On the occasion of International Clinical Trials Day, on 18 May 2026 the Clinical Trial Center (CTC) of the Department of Integrated Research and Innovation Activities (DAIRI) of the IRCCS-AOU “SS. Antonio e Biagio e Cesare Arrigo” of Alessandria held the event “From Data to Decision: Infrastructure and Governance for Competitive Clinical Research”, which gathered Researchers, Institutional Representatives and Stakeholders from the clinical research field of national and international relevance.

The day was structured around four sessions focusing on CTC governance, Health Technology Assessment (HTA), digital innovation and artificial intelligence to ensure data quality and the validation of electronic systems in clinical trials.

Among the key topics discussed, particular emphasis was placed on data governance as a driver of healthcare innovation, the importance of multidisciplinary expertise, the valorization of Real-World Evidence and electronic system compliance. These elements are essential to transform reliable data into scientific evidence and increasingly effective clinical decisions. The message shared by all Speakers was clear: Clinical Trial Centers represent a strategic infrastructure to ensure quality, competitiveness and innovation in clinical research, while supporting the advancement and innovation of the Healthcare System.

International Clinical Trials Day is an opportunity to celebrate scientific progress while recognizing the dedicated professionals whose work makes every clinical trial possible.

To mark International Clinical Trials Day 2026, SICRES, launched a storytelling campaign highlighting the people behind clinical research. Through a short video featuring one of our Project Coordinators, the campaign offered a glimpse into the diverse responsibilities involved in clinical trials—from coordinating multidisciplinary teams and maintaining accurate documentation to supporting investigators, managing investigational products, and ensuring compliance with study protocols.

The campaign emphasized that clinical research is driven by people working together to protect participants and ensure reliable data. Behind every successful study is a multidisciplinary team of investigators, coordinators, research nurses, pharmacists, data managers, laboratory personnel, and other professionals whose expertise and commitment contribute to high-quality research.

At SICRES, we believe that investing in people is as important as investing in infrastructure. By recognizing clinical research professionals and sharing their stories, we hope to inspire the next generation to pursue careers in clinical research and increase public understanding of their essential role in advancing healthcare.

Every breakthrough begins with people—professionals, participants, and partners working together to improve health and transform lives.

Watch full interview

On the occasion of International Clinical Trials Day on May 20, the Burapha University Clinical Research Center (BUU CRC), Thailand, organized a Researcher Meeting to raise awareness of the importance of clinical research and recognize the valuable contributions of researchers and research teams.

The meeting provided a platform for researchers and clinical research personnel to exchange experiences, discuss ongoing clinical research projects and upcoming studies, and share ideas for enhancing the quality and standards of clinical research.