This session will give an in-depth examination of Central Statistical Monitoring (CSM) with emphasis on the following issues:
- Statistical principles underlying Central Statistical Monitoring
- On-site monitoring vs. key risk indicators vs. CSM
- Operational challenges in implementing CSM
- Case studies identifying the impact and utility of this unique
- The added value of CSM:
1. Improving data quality and integrity
2. Reducing regulatory submission risk
3. Driving down costs on On-site Monitoring and SDV
4. Adhering to the regulatory guidelines and driving a Risk-Based Monitoring strategy
Marc Buyse, Sc.D, Founder, CluePoints
Marc Buyse holds master’s degree from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). Prior to founding the International Drug Development Institute (IDDI) in 1991, Mr. Buyse worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute in Boston. He has held board positions in several statistical societies.
Mr. Buyse is founder of CluePoints and an Associate Professor of biostatistics at the Limburgs Universitair Centrum, Diepenbeek, Belgium. His research interests include clinical trial design, validation of biomarkers and surrogate endpoints, randomization techniques, statistical methods in oncology, statistical detection of errors and meta-analysis.
For a list of publications visit http://publicationslist.org/marc.buyse
Brian Nugent, Associate Director, Clinical Operations, Gilead Sciences, Inc.
Dr. Nugent has spent over 15 years in clinical operations with various medium and large bioPharmaceutical companies and has within the last several years developed multiple quality risk management systems. He is currently leading ClinOps efforts to develop the use of Central Statistical Monitoring at Gilead Sciences and will speak today to the clinical operations feedback to the CSM pilot efforts.
Who Should Attend?
Senior level executives from companies currently conducting clinical trials
CluePoints is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct.
Aligned with guidance from the FDA and EMA, CluePoints is deployed to support traditional on-site monitoring and can be implemented as the engine to drive a risk-based monitoring strategy.
The value of using CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.