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 […]
Risk-Based Management And The Difference Between Key Risk Indicators And Central Statistical Monitoring
ClueBot here! 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 […]
New FDA Guidance Encourages Sponsors To Use Centralized Statistical Monitoring For Improved Data Quality
Background The recent release of the final guidance document detailing the FDA’s stance on the “Oversight of Clinical Investigations” is welcome news for the biopharmaceutical and medical device industry. The guidance clearly describes how central monitoring methodologies should be used, where appropriate, to oversee studies and effectively monitor clinical investigations to protect subjects and enhance […]
Is Risk-Based Monitoring The Answer To Data Quality Issues?
It’s no secret that data quality is at the heart of every clinical trial. Data validation is one of the main objectives in the FDA’s pre-approval inspection (PAI), which is performed to contribute to the FDA’s assurance that all submitted data are accurate and complete. For example, in clinical trials where patients self-administer diaries to record important […]
CluePoints Launches Powerful & Pragmatic Solution To Risk-Based Monitoring
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 […]
