This webinar will provide a regulatory perspective on what is expected from an independent and objective assessment of clinical data. Discussion topics will include:
- What the EMA and FDA are encouraging sponsors to look at as part of their assessment of data quality
- Identifying the different types of data analysis required to de-risk your study
- A review of case studies that exemplify a powerful, holistic approach to data assessment
Marc Buyse, Founder, IDDI and CluePoints Francois Torche, CEO, CluePoints
Marc Buyse holds master’s degrees 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, he had 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.
He is the 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 (http://publicationslist.org/marc.buyse)
Francois Torche, CEO, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 15 years in the Pharmaceutical industry, he has held positions as statistical programmer, SAS and JAVA developer and IT project leader for companies such as GSK, UCB and IDDI. During his ten year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the SMART™ engine, a patent-pending software solution and the underpinning of CluePoints. Francois has served as CluePoints’ Chief Executive Officer since the company’s inception in 2012.
Who Should Attend?
Senior level executives from companies currently conducting clinical trials
- Medical Device
CluePoints is a Central Statistical Monitoring solution that employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data. By identifying anomalous data and site errors, corrective actions can be taken ensuring data quality and a reduction in overall regulatory submission risk.
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.