Which clinical trials need a Clinical Endpoint Adjudication Committee?

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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January 8th, 2017

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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December 30th, 2016

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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December 26th, 2016

China’s dynamism requires a nimble CRO with extensive research networks

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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December 15th, 2016

Working with CRM to move Malaysia forward

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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November 23rd, 2016

South Korea: Clinical trial opportunities and advantages

Over the last 10 years, South Korea has increasingly become a global clinical trial (CT) hub and has established itself as one of the leading CT destinations in the Asia region. In 2015, South Korea approved a total of 675 trials from South Korean and multinational drug makers for early phase studies that would lead […]

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November 19th, 2016

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