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

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

Overcoming the diversity in the South East Asian region for a global clinical trial

Sponsors are increasingly seeking emerging areas to conduct clinical trials for new patient pools and better recruitment. However, successful implementation of these trials in areas such as South East Asia requires operational strategies that circumvents the inherent diversity of these regions. In these regions, language, culture, infrastructure and resources are very different from country to […]

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December 3rd, 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

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