Central Statistical Monitoring Should Support Key Risk Indicators
As you may well know, much of the early work in Risk-Based Monitoring has focused on relatively simple Key Risk Indicators (KRIs) and traffic-light dashboards, which are easy to understand. However, there is now a growing requirement to complement this approach with a more sophisticated and comprehensive analysis of data using a Central Statistical Monitoring (CSM) methodology. […]
Are The Regulatory Authorities Ready For The Adoption Of Risk-Based Monitoring?
Firstly, thanks to those of you who got involved with our recent discussion about current best practice in Risk-Based Monitoring, it was great to hear from you. Next, we asked our partners to tell us about how they think the regulatory authorities will respond to the adoption of Risk-Based Monitoring, and importantly, if they are […]
Risk-Based Monitoring Insights From The Industry: Dr. Peter Schiemann
In the fourth installment of the CluePoints Risk-Based Monitoring Q&A series, we spoke to Dr. Peter Schiemann, Managing Partner and Co-Founder of Widler & Schiemann, who had some interesting views to share with us. When it comes to the practical implementation of Risk-Based Monitoring, where do you observe differences in current best Risk-Based Monitoring practices between […]
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 […]
