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

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

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

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