Looking to the future, RBQM can be applied across studies, programs, and organizations alongside machine learning and artificial intelligence to identify program, organization, or industry trends.

Critical to Quality (CtQ) factors, cited and explained in ICH E8 (R1), are designed to confirm that a clinical study is designed to answer the research questions and to focus on monitoring variables that matter.

RBQM applies this principle to the entirety of a clinical trial, allowing sponsors to manage data quality continuously. Advanced statistical methods have been highly effective at powering centralized monitoring of data from sites in near real-time.

It also specifies that the monitoring plan should define the specific risks that the monitoring must address. Since all quality management processes are dynamic, the 2013 EMA Reflection Paper on Risk-Based Quality Management (RBQM) in clinical trials …

Elements of RBQM can be implemented individually and independently to great success, making clinical trials better, faster, and cheaper for sponsors and CROs – and safer for patients.

A rising tide of clinical trial data is flooding the pharmaceutical industry, offering boundless potential to chart new development pathways.

CluePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical trial data with digital or remote tools (eCOA, ePRO, etc.) without putting the quality of that collected data at risk in the below interview.

The clinical research industry is currently in a transition as it moves to adopt Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) as its primary quality management methods. The approach, endorsed by both FDA and EMA and encoded in the ICH E6 (R2) GCP update, encourages less reliance on traditional on-site monitoring practices, such as frequent …