Clinical Research Malaysia (CRM) has marked a significant milestone in strengthening the country's position as a regional clinical research hub through strategic partnerships and record-breaking trial activity. The organization signed a Memorandum of Understanding with CSI Medical Research, a ClinChoice Company, aimed at promoting Malaysia's clinical research capabilities to international biotechnology firms while advancing training initiatives for study coordinators.
Strategic Partnership Expands International Reach
The MoU, signed by Dr Akhmal Yusof, Chief Executive Officer of CRM, and Mr Goh Tse Seng, Regional Head of Clinical Development at CSI Medical Research, represents a key step toward CRM's Vision 2033 to establish Malaysia as the preferred hub for clinical research in the region. The partnership focuses on capability development initiatives, particularly in training and upskilling study coordinators, addressing a critical need in the clinical research ecosystem.
CRM's Centre of Excellence (CoE) has already demonstrated success in talent development, producing 30 graduate trainees equipped with foundational training in clinical research. This initiative supports the broader goal of building a skilled workforce capable of supporting Malaysia's growing clinical research activities.
Record-Breaking Early Phase Research Activity
Malaysia achieved unprecedented success in early-phase research during 2024, with five First-in-Human (FIH) studies awarded—the highest number in a single year since the launch of CRM's Phase 1 Realisation Project in 2016. These studies were conducted at Sarawak General Hospital, an FIH-accredited site by the National Pharmaceutical Regulatory Agency (NPRA), highlighting the country's growing capabilities in conducting complex early-phase trials.
The achievement reflects Malaysia's proven track record in delivering global clinical trials with speed, quality, and reliability, driven by the dedication of investigators, study coordinators, and industry partners.
Expanding Clinical Trial Portfolio
According to CRM's Annual Report 2024, unveiled by Health Minister YB Datuk Seri Dr Dzulkefly Ahmad, Malaysia initiated 267 new sponsored clinical research studies last year. This brings the total number of sponsored studies to over 2,500 since CRM's establishment in 2012, demonstrating sustained growth in the country's clinical research sector.
The report highlights Malaysia's transformation of its health system through the Malaysia MADANI framework, which drives innovation through data and technology while improving access to cutting-edge therapies for Malaysian citizens.
Infrastructure Development and Public-Private Partnerships
Sunway Medical Centre (SMC) in Sunway City has signed a memorandum of understanding with the National Institutes of Health (NIH), Ministry of Health, to advance medical research and Phase 1 clinical trials. The partnership strengthens collaboration between public hospital-based Clinical Research Centres and SMC, creating opportunities for training, knowledge exchange, and joint branding initiatives.
SMC is developing a dedicated Phase 1 Clinical Trial Unit within its facility, expected to be completed and accredited by 2026. According to SMC CEO Seow Vei Ken, the on-site location will provide patients with easier access to clinical trials and novel therapies, addressing a key barrier to trial participation.
Regional Leadership and Future Outlook
CRM, in partnership with the Ministry of Health Malaysia, is leading an ASEAN-level initiative to expand industry-sponsored clinical trials across Southeast Asia. This strategic move positions the region as a competitive and collaborative destination for global research investment, leveraging Malaysia's established infrastructure and expertise.
The upcoming CRM Trial Connect 2025, scheduled for May in Kuala Lumpur, will gather at least 1,000 clinical research stakeholders for an annual international conference. The event will serve as a platform to highlight Malaysia's achievements and discuss future opportunities in clinical research.
These developments underscore Malaysia's commitment to serving as both a scientific frontier and a strategic pillar in advancing national and regional health outcomes through clinical research innovation.
