Sylviane de Viron

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.