How Will Risk-Based Monitoring Coexist With Other Clinical Trial Technology?
We’ve been really enjoying hearing your thoughts on the latest Risk-Based Monitoring hot topics over the last few weeks, so thank you to everyone who has taken time out to be involved. Next on our agenda is technology. As Risk-Based Monitoring takes off and becomes more mainstream within clinical studies, how will new technology exist […]
Risk-Based Monitoring Insights From The Industry: Karen Fanouillere
Part Three In the third of an eight-part Q&A series which aims to explore some of the current hot topics in Risk-Based Monitoring (RBM), CluePoints has been speaking with Karen Fanouillere, Biostatistics Project Leader for 15 years and now Head of Clinical Information Governance at Sanofi about the perspectives of a large pharma company in implementing […]
Risk-Based Monitoring Insights And Strategies From The Industry: Adam Butler
Part Two Recently, CluePoints has been taking time out with some of our valued partners to discuss hot topics in Risk-Based Monitoring (RBM). Here, in the second of an eight-part Q&A series, we spoke with Adam Butler, Senior Vice President, Strategic Development & Corporate Marketing at Bracket Global, who shared these valuable insights with us. […]
Is It Too Soon To Define Best Practice When It Comes To The Practical Implementation Of Risk-Based Monitoring?
Last week CluePoints launched its eight-part Q&A blog series which aims to explore the current talking points in Risk-Based Monitoring (RBM). We’ve been gathering insights from a number of CluePoints’ partners but are keen to open up the discussion to the wider industry. The first question we put to our partners was centered around the […]
Risk-Based Monitoring Insights From The Industry: Craig Serra
Part One In the first of an eight-part Q&A series which aims to explore some of the current hot topics in Risk-Based Monitoring (RBM), CluePoints has been speaking with Craig Serra from Pfizer. Craig is currently Senior Director and Data Management Business Process Owner, with accountability for the data management process in study conduct and […]
Transcelerate’s Latest Paper – “Detecting Data Quality Issues In Clinical Trials: Current Practices And Recommendations”
Pressure is growing for sponsors to implement robust controls to identify data quality issues that may impact trial outcomes, and this is understandable given the number of submissions that fail the first-cycle review due to data discrepancies and the high-profile fraud cases that have emerged in recent years. The growing complexity in trial protocols and […]
Want Full Control Of Your Risk-Based Monitoring Analyses?
CluePoints introduces a web-based Central Statistical Monitoring (CSM) SaaS solution As you may have read on a few industry blogs, we recently launched a Software-as-a-Service (SaaS) solution that can be implemented as part of a sponsor’s Risk-Based Monitoring (RBM) strategy. The web-based Central Statistical Monitoring (CSM) SaaS offering enables customers to control the upload of clinical data […]
The Evolution Of CluePoints’ SMART Engine
Regarding CluePoints’ statistical approach to risk-based monitoring in clinical trials, we are often asked questions about sample size, such as: “How many subjects are needed per site to perform your analyses in an ongoing study?” “Do you have a minimum sample size recommendation for this approach?” “How can this be applied to trials with many centers and few […]
CluePoints’ Commentary – EMA Reflection Paper On Risk Based Quality Management In Clinical Trials
The final version of the EMA Reflection Paper on Risk Based Quality Management in Clinical Trials is now available. This document, as well as the FDA Guidance, significantly benefits the industry with the on-going efforts to introduce and develop the risk-based monitoring (RBM) paradigm. The purpose of this reflection paper, as stated by the EMA is to “encourage […]
A CluePoints Case Study: Confirmation Of Fraud – Diaries Completed By Staff
In a phase III trial in vascular disease, over 4,500 patients were randomized across 160 sites. The CRF included 480 variables for 32 domains. The sponsor had a specific concern and the CluePoints solution was deployed after the last patient last visit to prove how significant the issue might be. More than 45,000 p-values were […]
