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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2017年1月8日

Utilizing Clinical Research Organizations for late Phase I studies

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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2017年1月4日

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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2016年12月30日

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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2016年12月28日

Steadying confidence for clinical trials in India

For over 30 years, India has been conducting global clinical trials. With over 500 sites and over a billion people, India was a key destination for clinical trials for its vast treatment naïve clinical population. However, the environment has fluctuated throughout recent years, as The Central Drugs Standard Control Organization (CDSCO), India’s regulatory agency for […]

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2016年12月21日

SMARTHealth – A study on e-health in rural communities

Health systems in low and middle income countries continue to face considerable challenges in providing high-quality, affordable and universally accessible care – this is primarily evident in rural areas. As of 2014, approximately 876.1 million people live in rural areas within India with poor access to primary healthcare. This amounts to more than two-thirds of […]

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2016年12月19日

Research confirms link between birthweight and cancer

New research from the International Childhood Cancer Cohort Consortium (I4C) confirms that childhood cancer is linked to birthweight. The incidence of childhood cancer appears to be slowly rising, at a rate of approximately 1% per year in developed countries. Link between birthweight and cancer Risk rose by 26 percent for every kilogram increase in birthweight for […]

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2016年12月17日

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 mos […]

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2016年12月15日

Overcoming recruitment challenges in a type 2 diabetes study

Patient recruitment is crucial for the success of any clinical trial. The main objective of recruiting is to identify suitable patients that meet protocol requirements, allowing protocol quest […]

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2016年12月1日

How Healthcare Apps are helping to Improve Clinical Trials

Smartphones are changing our lives every day. Almost every industry is affected by the mobile revolution in one way or another. At 乔治临床( George Clinical ), we are in the business of clinical t […]

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2016年11月15日

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