At Southern Star Research, we are committed to advancing medical innovation and improving patient outcomes by providing premier clinical trial services across Asia Pacific.
Our operational capabilities founded in Australia and New Zealand, now span key countries in Asia including South Korea, Malaysia, Singapore and Taiwan.
This offers our sponsors reach to much larger populations and broader disease profiles for their clinical trial data sets.
Asia is home to around 60% of the world's population. Rapid globalisation has led to changes in regional disease profiles, and improvements in regulatory processes and language skills sees the Asian region aligning with the gold standards set by North America, Europe, and of course Australia & New Zealand.
Many countries in Asia have highly regarded Key Opinion Leaders, impressive medical systems, and streamlined regulatory and ethical review processes. Some countries have developed high-tech innovation hubs for product development, so the region is now implementing local and global clinical trials.
Conducting clinical research in Asia is cost-effective due to lower operating costs compared to Europe & USA. There are reduced labour costs and site facility costs, and access to large patient numbers which facilitates recruitment. Local site and company staff are typically bi-lingual and experienced working to local requirements and the globally accepted standards of ICH and ISO.
Malaysia has a population of around 35 million and is a close neighbour of Singapore. There are multiple large teaching hospitals and medical clinics in Malaysia, many of which fall within the Clinical Research Malaysia (CRM) group which streamlines start-up processes including site contracting. The primary official language is Malay however English is widely used and has become the second official language. Participant facing materials need to be translated into Malay and sometimes Chinese and Tamil.
The National Pharmaceutical Regulatory Agency (NPRA) and Medical Device Authority (MDA) are the main regulatory authorities and the Malaysian Guideline for GCP, which is based on ICH, applies. Import licences are required to import products to be used in a clinical trial unless an exemption applies. All trials also require submission to local IRBs based on site locations and affiliations. Submissions are made in English and the total approval time is typically 12-20 weeks. Clinical trial sites in Malaysia recruit well, generate high quality data and are very cost competitive within the global setting.
Singapore is a country of around 6 million people sitting just north of the Equator in Southeast Asia. The primary official language is English. Singapore is known for its stringent regulatory standards, esteemed health professionals and world class medical facilities.
Assuming Clinical Trial Application pathway, documentation is submitted in English to both the Health Sciences Authority (HSA) and IRB in parallel. Post approval, patient facing materials are translated into Chinese and Malay. Total approval time is in the order of 8-12 weeks for medicines and 14-16 weeks for gene or cell therapy. Device trials require IRB approval and are then notified to the regulator.
South Korea is in Northeast Asia with a population of around 52 million concentrated into large cities in low-lying areas. Korean is the official language and all documentation for clinical trials needs to be translated prior to use. The healthcare system in South Korea is considered one of the best in the world, with high-tech medical centres and university affiliated hospitals housing well-trained healthcare professionals. KGCP, which is based on ICH GCP, applies and most staff working in the clinical trials setting, including CRAs, hold government certifications applicable to their role. Clinical trial sites are also registered / certified.
Clinical trial applications are made to the Ministry of Food and Drug Safety (MFDS) as well as local IRBs. Import of products for clinical trials, including lab kits and other ancillary supplies requires Clinical Trial Materials (CTM) application. The initial MFDS application review period is 6 weeks and questions / requests for further information will add to the overall review time. The total approval period including IRB and CTM can be as short as 8-12 weeks and translation time for all documentation must be included prior to submission.
Taiwan, a densely populated group of islands in East Asia, is home to around 24 million people. Taiwan's medical system is well-equipped for clinical trials, with experienced PIs at recognized and registered sites. The Taiwanese local GCP, which is available in both Chinese and English, is a testament to our commitment to high standards.
The Taiwan Food and Drug Administration (TFDA) regulates clinical trials, with submissions made in parallel to the TFDA and IRBs. The initial review approval can be completed in as little as 4-6 weeks. All documentation must be translated before submission into Tradtional Chinese, and local IRB sub-reviews may be required after the main review.
At Southern Star Research, we leverage our in-depth knowledge of the Asia-Pacific region, our strong local presence and our gold standard systems and processes to deliver exceptional clinical trial services to our global biotech, pharmaceutical, and medical device sponsors.
Partner with us to leverage the unique advantages of conducting clinical trials in both Australia and the wider Asia-Pacific region for later-phase clinical trials.
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Each member of our Leadership Team boasts an average of 30 years experience. Our clients have access to an extraordinary group of Clinical Research professionals, whose experience covers Multinational Pharmaceutical companies, Biotechnology, Medical Device, CRO’s, research institutes, Universities, Industry Associations & Government Bodies. Together, we ensure that every aspect of your unique and novel drug study clinical trial is handled with scientific precision, care, and foresight.
Our team has all of the tools, knowledge and experience to solve almost any issue that may arise during the complex clinical trial process.
We recognize that each study is unique and different and there are nuances that need to be resolved proactively.
Our advisory board of top-tier specialists in multiple therapeutic areas engage in the early stages from protocol design in constructive discussions to anticipate challenges and enhance study efficiency throughout the study.