Supplements, Oct 2, 2007 - Applied Clinical Trials

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Supplements, Oct 2, 2007
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Viewpoint
Centralizing the Laboratory
By Hermann Schulz, MD
Strategies for labs to support global trials and meet the needs of sponsors worldwide.
Elements of a Successful Platform for Image Analysis
By Colin Rhodes
To select the right CRO as an imaging partner, sponsors must first be aware of what to look for.
Feature Article
Early Accuracy in New Drug Safety Analysis
By Frank G. Yanowitz, MD
A look at ECG evaluation for drug-related alterations in repolarization and Torsade de Pointes.
Imaging Sites and Clinical Trial Harmony
By Christina Mastandrea
How imaging CROs minimize data variability in multisite studies and create the necessary consistency.
Visionary Biomarkers
By Johannes T. Heverhagen , Michael V. Knopp
The use of imaging in trials shows great promise, but proper application requires early dialogue.
Bonus Article
Cardiac Safety: The Merits of ECG Centralization
By Jeffrey S. Litwin
A call to sponsors to rethink the role of ECGs in drug development and the use of central core labs.
The Local Central Lab Model
By Dr. Francisco Lećo, Jr
With globalization of trials comes the difficulties of biologic sample logistics. Enter the centralized/decentralized laboratory model.
Laboratory Resources
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