Data – The Foundation of Clinical Trials

Apr 11, 2017

The life sciences industry has been fundamentally altered in recent years. Diseases that were once considered life-threatening and terminal are now being managed as chronic conditions. Previous chronic illnesses are treatable and curable, while other diseases have been reduced to irritations or consigned to the history books. Richard Young, Vice-President, EDC, Veeva Systems, discusses how a changing world brings data to the forefront, but how do we manage it all to make the biggest impact. ...

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Five Reasons to Rethink Paper ECGs

Apr 11, 2017

Cardiac safety issues are among the most common reasons for promising drugs being halted in development and not brought to market. The ICH E14 Guidance for Industry requires every new drug to be tested for QT prolongation to predict the risk of Torsades de Pointes (TdP), a lethal arrhythmia. However, sponsors who rely on site-managed ECGs may be risking data quality. There are significant differences between site-managed and centralised ECG data collection and analysis. Ellen Street, Executive Vice President, Cardiac Safety at ERT, explains why it is critical that sponsors understand how their selected method could make the difference between ...

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Improving Site Performance: It’s All About Relationships

Apr 11, 2017

The relationships between sponsors, CROs and study sites can present many challenges in clinical trial planning and execution. Any relationship can be complicated, but the way in which these parties interact with each other can have a significant impact on the overall success of a clinical trial. In this article, Jeffrey Zucker, Vice President of Feasibility and Recruitment Optimization at Worldwide Clinical Trials, offers strategies for establishing and maintaining key relationships, and advice on how sponsors and CROs can build and enhance site partnerships to optimise study execution from trial start-up and recruitment through to implementation. ...

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Three Ways to Mitigate the Risk of Late-stage Failure in CNS Drug Development

Apr 10, 2017

Central nervous system (CNS) disorders have long been the Bermuda Triangle of drug development. For example, a 2014 study of Alzheimer’s disease (AD) drugs tested between 2002 and 2012 showed that 99.6% of them failed one of Phase I, II or III trials. Many of these AD drugs failed late, in large Phase III trials, making the failures costlier and more dispiriting for researchers, drug developers, and, certainly, patients. Rebecca M. Evans, MD, MS, Global Therapeutic Area Head for CNS and her team at Parexel, serve the readers with a detailed study of CNS drug development. ...

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Technology Advances in Feasibility, Recruitment and Retention

Jan 8, 2016

Biopharmaceuticals are intensely focused on efficiency and time to market; however, the nature of clinical trials continues to present obstacles to attaining these goals. Today’s trials are still far too costly, and study cycle times remain too long to achieve a recoverable time to market. In response, many biopharmaceuticals are focused on reducing study cycle time by pinpointing the right countries, sites and patients. Paul Evans and Xavier Flinois at Parexel share their thoughts with the public on technology advances in feasibility, recruitment and retention. ...

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