The face of individual health care is changing and improving, thanks to wearables. Wearable health and fitness devices are becoming more popular by the day and with our mobile devices and wearables prompting us to keep up with good health habits, overall health is improving too. As individuals are more aware of their health, more […]
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A key step in developing a new drug is the transition from the laboratory to the human subject in a Phase I clinical trial, where the new compound is given to humans for the first time. A Phase I trial is the gateway between scientific research and clinical medicine. Generally, in-human Phase I studies are […]
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China is Australia’s largest trading partner – worth $8.8 billion in 2014-2015. China and Australia are also growing partners in science and research and this is an important area for growth in bilateral relations. China is and has been Australia’s key focus for science and research collaboration efforts; generating advances in medical research, biodiversity, net […]
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China’s meteoric growth over the past twenty years (or so) has seen it go from strength to strength, particularly in the clinical trials sector. As the clinical trial market of the world’s most populous nation (and second largest economy) continues to mature, so does their regulatory requirements. These regulatory adjustments pose a risk to sponsors […]
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Active international collaboration has facilitated the rise of the Asia-Pacific region in global clinical research. In the first two parts of this blog series, we’ve discussed how Japan and South Korea – whose clinical research environments vary significantly from each other – share many common interests in their pursuit for advancing clinical R&D. The open […]
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Japan has taken significant steps in establishing itself as a major player in the global clinical research community, driving the demand for more clinical trials across East Asia as a result. By officially acknowledging and seeking clinical data from the Asia-Pacific region, Japan is facilitating a dialogue with one of the most powerful and capable […]
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Sponsors are increasingly seeking emerging areas to conduct clinical trials for new patient pools and better recruitment. However, successful implementation of these trials in areas such as South East Asia requires operational strategies that circumvents the inherent diversity of these regions. In these regions, language, culture, infrastructure and resources are very different from country to […]
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The Malaysian government has committed funding to improve the healthcare systems in order to further support clinical research. Clinical Research Malaysia (CRM) is a non-profit organisation – wholly owned by the government of Malaysia, which intends develop infrastructure for Clinical Research Centre networks, and be able to support global industry sponsored research (ISR) requirements. Recently, […]
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New initiatives from the country’s regulator aim to smooth the registration of trials and ensure prospective participants fully understand what will be involved through mandatory AV recording of the consent process. Clinical trial applications in India are taking a step forward, with the approval of a Central Drugs Standard Control Organisation (CDSCO) IT-enabled system from […]
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Effective 2nd August 2016, the Central Drugs Standard Control Organization (CDSCO) India released new circulars in relation to the conduct of clinical trials. These new circulars have modified the trial requirements for sponsors wishing to conduct clinical trials in India. Furthermore, the CDSCO have addressed matters that may assist in reducing clinical trial timelines and […]
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