In our November issue:
PEER-REVIEWED
The Basics of Centralized Monitoring
Adam Beauregard, Vadim Tantsyura, Fernand Labrie
In multicenter clinical trials, centralized monitoring (CM) is considered the most efficient way to ensure patient safety, trial integrity, and data quality. Authors outline the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.
FEATURED
RBM Versus SDV: Real Results
Penelope Manasco, MD, Eric Herbel, Sean Bennett, MD, PhD, Michelle Pallas, Lisa Bedell, Deborah Thompson, Kevin Fielman, PhD, Garrett Manasco, Charlene Kimmel, Everett Lambeth, Lisa Danzig, MD
With no existing head-to-head comparisons of different trial oversight methods, this pilot study compares a risk-based monitoring and remote trial management approach with traditional on-site source data verification. The review focuses on how analysis and safety data are collected, in addition to the actual data for analysis.
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NEWS
Washington Report: Jill Wechsler details new FDA initiatives to advance therapies for rare diseases.
EU Report: Peter O'Donnell examines the contrasting approaches in Europe when it comes to designing health policy.
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CLOSING THOUGHT
The Key to Alzheimer's R&D
Edward I. Ginns, MD, PhD
Pharmaceutical and diagnostics companies need to better align themselves with each other in Alzheimer's disease research–to help turn science and data into actionable medical innovations.
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