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

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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January 4th, 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

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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December 28th, 2016

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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December 21st, 2016

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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December 19th, 2016

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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December 17th, 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
Overcoming recruitment challenges in a type 2 diabetes study

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 questions to be answered. However, patient recruitment does not always go to plan. The leading cause of missed clinical trial deadlines is patient recruitment, taking up a significant […]

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December 1st, 2016

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 George Clinical, we are in the business of clinical trials and we see how even the clinical trial industry is getting a big makeover thanks to healthcare applications that are a growing trend […]

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November 15th, 2016

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