Steve Young

The need to boost education, shift culture, and embrace new technologies.

Analysis confirms there is a relatively high degree of variability in risk planning results across studies.

New data shows the adoption of studies introducing quality tolerance limits continues to surge—and offers clues on focus of implementation.

Analysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.

Study teams often face challenges in maintaining detailed and accurate documentation of risk signals.

Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.

Metric derived from CluePoints central monitoring platform assesses average total cycle time from risk signal creation until closure.

As challenges like regulatory adherence, cost, and timelines become more complex, sponsors are seeking out new ways to incorporate risk-based approaches.

Industry sees high increase in the use of QTLs.

Study indentifies trends in most commonly used KRIs.

How optimizing RBQM risk detection reduces the efforts caused by false signals.

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.

The importance of applying change management techniques throughout the preparation, planning, and execution of RBM and RBQM approaches.

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.

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.