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 […]
