Risk-Based Monitoring Software

Webinar Recording: What Does ICH E6 R2 Mean for Me and My Company?

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This week, CluePoints hosted a webinar with Paragon Solutions, which was geared towards preparing attendees on how to take advantage of the ICH E6 revisions to ensure appropriate consideration of risk in study design and management. Attendees learned about the key ICH E6 updates related to Risk-Based Monitoring and their purpose, how Central Statistical Monitoring and Key Risk Indicators will work for them, and how to use the E6 R2 to support their organization’s transition to Risk-Based Monitoring.

6th Annual CROWN Congress: Sessions you Can’t Afford to Miss + 15% Discount Code

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It’s really no secret that the evolving regulatory landscape for clinical trials is a hot topic amongst the community. Just take a look at the agenda for the 6th Annual CROWN Congress, it’s jam-packed with sessions focused on the eagerly anticipated ICH E6 revisions, the new EU 536/2014 clinical trial regulations, risk management and centralized monitoring.  

FDA Signs Agreement with CluePoints to Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

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12 October 2016

Cambridge, MA –  FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.  Misconduct in clinical research, including, but not limited to the falsification or omission of data in reporting research results, places all subjects in that trial at possible safety risk. 

Central Statistical Monitoring Should Support Key Risk Indicators

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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.…

The Evolution of CluePoints’ SMART Engine

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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 patients in each center?”

Previously, our recommendation was at least 4 patients per center and 10 centers per study, although it was possible to group the data differently (e.g.…

Risk-Based Management and the Difference Between Key Risk Indicators and Central Statistical Monitoring

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I’m back! Did you miss me? I’ve actually dropped by to share some exciting news.  A few months ago, my wonderful creator at CluePoints, Dr Marc Buyse, hosted a complimentary webinar with his friend Brian Nugent from Gilead Sciences. I wanted to share with you some of the information they discussed as I made my guest appearances throughout the presentation [My parents, components of a super-computer and a Gulfstream jet, would be so proud!

CluePoints Launches Powerful & Pragmatic Solution to Risk-Based Monitoring

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As biopharmaceutical sponsors search for the optimal approach to targeted monitoring and reduced  Source Data Verification (SDV), CluePoints introduces an Intelligent Statistical approach like no other.

A new software and service provider of Intelligent Statistical Monitoring solutions – CluePoints – has been launched to address the increasing industry need for
a pragmatic approach to enable the risk-based monitoring theory to become a reality.…