Steve Young

CluePoints

Articles

Ensuring Quality in Clinical Research with Centralized Statistical Monitoring, On-Site Monitoring, and Clinical Data Management

September 14, 2020

Organizations implementing RBM continue to struggle with a number of questions regarding the relative contributions to quality of on-site monitoring, centralized statistical monitoring, and clinical data management reviews—and what role each activity should play.

A Roadmap for Implementing Risk-Based Monitoring and Quality Management

April 08, 2019

Integrating a systemic risk management strategy for identifying clinical trial risks-and the importance of applying change management techniques throughout the preparation, planning, and execution stages.

Beyond RBM: How Intelligent Analytics are Being Used to Drive Value and Support ICH Compliance

November 03, 2017

Steve Young looks at the tremendous benefits that organizations stand to reap by effectively implementing the core principles included in the ICH update and the significant opportunities that the application of intelligent analytics and centralized statistical monitoring may present.