Significant changes ahead for drug development in China?

Significant changes are ahead for clinical research in China. The Public Consultation Notice for Policies to Encourage Innovation and Reform in Regulation of Drug and Medical Device Clinical Testing was released by the CFDA on 11 May, 2017. These proposed changes herald an exciting new era for drug and device development. If implemented in full, […]

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Taiwan: The Clinical Trials Gateway to China?

Taiwan sits, along with its smaller counterparts, Singapore and Hong Kong, as one of the gateway countries to running a clinical trial in China. Although Hong Kong’s regulatory ties are more formalized with China, than Taiwan, Taiwan has the right environment and population to make the possibility of greater regulatory cohesion with its giant neighbour, […]

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South Korea: A Top Clinical Trial Destination

Clinical trial sponsors and CROs don’t need to imagine South Korea as a country of limitless potential, they know it is. South Korea is a clinical trial destination with world-class medical infrastructure, a highly-educated, relatively wealthy and healthy population. Their investigators are, on the whole, actively engaged in clinical trials and keen to play their […]

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Which clinical trials need a Clinical Endpoint Adjudication Committee?

Increasingly, regulatory authorities are placing significant focus on clinical trial processes that ensure consistent, standardized, objective and unbiased reporting of safety and efficacy results; given that the definitions for many endpoint events include subjective components, and investigator-to-investigator subjective assessments may differ. Moreover, an increasing number of trials are now conducted in multiple geographies, and clinical […]

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Why digital health is beneficial to clinical trials

In the world of healthcare, time is always of the essence. Researchers are continuously looking for new solutions to help improve patients’ well-being and ultimately save lives. The discovery process of new treatments takes an enormous amount of time and resources in order to generate good evidence to prove that they are safe and that […]

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Thrombolysis will continue to be the mainstay for acute stroke treatment

Thrombolysis will continue to be the mainstay for acute stroke treatment, despite the recent revolution in neurointerventional clot retrieval. However, as there are ongoing limitations of thrombolysis of bleeding risk and reduced efficacy in large clots – what possible therapeutic advancements can complement or act as an adjuvant to thrombolysis? Neurointervention – effective, but limited […]

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Regulatory timelines in the Asia-Pacific

An at-a-glance round-up of the arrangements for clinical trial applications in 10 countries in the region. Australia Australia is unique in that its Human Research Ethics Committees (HRECs) have responsibility for the oversight and ongoing monitoring of trials, including reviews and approvals. The first step is submission of the clinical trial to the HREC for […]

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The Changing Role of the CRA in an RBM World

Approximately a third of clinical trials conducted utilize some elements of Risk Based Monitoring (RBM), with this figure expected to increase. Site monitoring has been identified as one of the largest components of clinical trial expenditure. With the change in the way that site monitoring is performed, the role of the Clinical Research Associate (CRA) […]

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China-Australia Free Trade Agreement – The Healthcare Opportunity

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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