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
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
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
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
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
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
