DIA 2023 Topic: The Industry-Wide Definition for RBQM
At the recent DIA 2023 Global Annual Conference, I focused my attention on discussions about the need for clear processes for reviewing audit trails, overseeing decentralized clinical trial (DCT) data, the impact of ICH E6(R3) on these areas, and the need for an industry-wide definition of Risk-Based Quality Management (RBQM).
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.) without placing the quality of that collected data at risk, in this DIA Global Annual Meeting 2023 interview.
RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)
A conversation with Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor
Women in Pharma 2023 | Growing Leadership and Choosing Your Priorities
The pharmaceutical industry has a problem – a failure to provide women with C-suite opportunities.
ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?
The ICH E6(R3) draft guideline document, currently open to public consultation, places the industry firmly in the risk-based era, making it clear that the benefits of comprehensive operational oversight and targeted data management are in no way limited to the process of monitoring alone.
RBQM Elements Have Seen Limited Adoption in Trials, New Global Survey Finds
Despite the push for greater use of risk-based quality management (RBQM) in clinical research, adoption of its most commonly used components by sponsors and CROs is limited and perceptions of their benefits are still varied, new findings show
Industry Trends: Cycle Time to Resolve Risk Signals
Central monitoring aims to detect emerging quality-related risks proactively during a clinical trial, resulting in study team intervention to address any confirmed issues and thereby drive optimal quality outcomes.
The Role of KRIs in Process-Driven RBQM Success
Using key risk indicators (KRIs) can improve clinical trial data quality in 80% of the sites on average.
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters
Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and suggest ways of implementing quality tolerance limits (QTLs) alongside existing risk-based quality management methodologies.
Quality Tolerance Limits: A Review of Industry Trends
An expectation for the use of quality tolerance limits (QTLs) was formally established in the International Conference for Harmonization (ICH) E6 (R2) GCP guideline published in 2016.
