Trendspotting: What’s Coming for Clinical Trials and Research in 2024
We spoke with leaders and experts in the Clinical Research community about their predictions for 2024.
Ukraine War’s Impact on Clinical Research: Evidence from Key Risk Indicators
Key risk indicators (KRIs) are commonly used as an important component of central monitoring to enable study teams to detect emerging quality issues of interest during a clinical trial. Given the large volume of KRI-related information now available for global clinical trials on the CluePoints risk-based quality management (RBQM) platform, we decided to take the […]
Using Machine Learning and NLP to Improve Central Monitoring Documentation
Central monitoring helps sponsors to proactively identify and remediate data quality issues during the conduct of clinical trials.
DIA Global Forum: 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 putting the quality of that collected data at risk in the below interview.
Solving the Rubik’s Cube of Competing Forces to Realize the Future of Clinical Research
Artificial intelligence (AI) has massive potential to advance clinical research.
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.
