From Risk-Based Monitoring To Risk-Based Quality Management
TL;DR Summary: Here are key definitions from our blog, “From Risk-Based Monitoring (RBM) to Risk-Based Quality Management (RBQM).” Risk-Based Monitoring (RBM): A strategy that uses software, data, and analytics to prioritize oversight on the most critical trial data and processes. RBM improves data quality, enhances patient safety, and reduces costs by enabling sponsors to identify […]
Webinar: The Future Of Clinical Trial Monitoring
In the wake of COVID-19, adoption of decentralized clinical research is taking off as sponsors explore ways to maintain continuity for existing studies while looking toward a more patient-centric future — bringing research to patients where they are with virtual trials. Regulators agree as reinforced by Stephen Hahn, FDA Commissioner, sharing that the agency will […]
New Paper: From RBM To RBQM – The Future Of Risk-Based Trial Management
A review of FDA marketing submissions between 2000 and 2012 revealed roughly one-third (32%) of all first-cycle review failures (16% of submissions overall) were driven by quality issues.1 Why was this? While the pharmaceutical industry had enjoyed economic growth in the 1990’s, drug makers started to face growing pressure at the turn of the century from […]
RBQM Doesn’t Have To Be Complicated, Risky Or Expensive: Q&A
On Wednesday, June 24, 2020, CluePoints delivered a webinar to demonstrate how using a combination of powerful analytics and comprehensive data visualization can be employed to ensure that no stone is left unturned in determining what issues are evident in studies and how to course-correct for a successful submission. If you missed the webinar, you […]
Beyond COVID-19: The New Normal In Risk-Based Monitoring (RBM) And Quality Management (RBQM)
Join our next webinar to learn first-hand how the CluePoints and Parexel partnership is driving best-in-class Risk-Based Quality Management Strategies to support clinical development. This session will focus on how early risk detection can be leveraged to detect issues across your trial and ensure operational excellence. As the COVID-19 pandemic continues, actions need to be prioritized to […]
Early Risk Detection During The COVID-19 Crisis – Your Questions Answered
On Tuesday, March 31, 2020, CluePoints delivered a webinar centred around the critical importance of early risk detection. Our presenter also shared insights on how to navigate risk management and risk assessment during the COVID-19 crisis. If you missed the webinar, you can watch it on-demand. Watching the webinar before digesting the answers shared in this document […]
Complimentary COVID-19 Risk Assessment Package Available To All At No Cost
COVID-19 Risk Planning As advised in the coronavirus guidances recently issued by FDA, EMA, and MHRA, it is important to perform a fresh risk assessment for each study to identify and mitigate risks pertinent to the COVID-19 crisis. Your organization is likely already aware of key challenges that will be common to most if not […]
Implementing A Risk-Based Quality Management Strategy – The Ultimate Guide
Every organization faces unique challenges when it comes to implementing a Risk-Based Quality Management strategy. There’s no ‘one-size-fits-all’ approach that will ensure success, as each organization has specific influencing factors such as therapeutic areas, existing processes, and various technologies. Our latest guide, produced by our Chief Scientific Officer, Steve Young, takes a look at considerations for ensuring not […]
Transitioning From A Risk-Based Monitoring Approach To Risk-Based Quality Management
This content was originally posted on Applied Clinical Trials on March 18, 2019 One of the most significant positive changes we have seen recently is the endorsement of ICH E6 (R2) which insists that Sponsors and CROs adopt a risk-based approach to study execution. This paradigm shift in the industry ensures that Sponsors undertake risk assessment during […]
ICH E6 R2 – The Clinical R&D Industry’s Response
Looking for the most up-to-date perspective on ICH GCP? Explore our deep dive into the latest ICH E6(R3) Guidance and what it means for modern RBQM practices, including key changes, timelines, and practical implications for Sponsors and CROs. Read it here. For decades now the complexity, cost, and duration of clinical development have been steadily […]
