Looking to the Future with RBQM - DIA Global Forum
Looking to the future, RBQM can be applied across studies, programs, and organizations alongside machine learning and artificial intelligence to identify program, organization, or …
Implementation of Critical to Quality Factors (CtQ) in a Clinical Trial
The DIA GCP-QA Community previously introduced Who Should Be in the Room? to define which functions should contribute to RBQM activities during protocol development, study conduct, or …
Part 1: AI and Data Quality in a Decentralized World - DIA Global …
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 …
Selecting a Risk-Based Monitoring Vendor: Ensure Compliance
Since all quality management processes are dynamic, the 2013 EMA Reflection Paper on Risk-Based Quality Management (RBQM) in clinical trials recommends that risks be monitored …
September 2020 - globalforum.diaglobal.org
Now, it is about Risk-Based Quality Management (RBQM), an ICH- and FDA-advocated approach to managing risk for the entire clinical trial lifecycle. Improving data quality and patient safety, …
Navigating the Data-Driven Transformation of Clinical Development
The FDA advocates lean principles and risk-based quality management (RBQM) to continually align data pipelines with patient needs. Data quality KPIs should embed across the product life …
Statistics Powering Risk-Based Quality Management
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.) …
Lower Costs, Shorter Timelines, and More Successful Study …
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 …