During this webinar, Cubist Pharmaceuticals and CluePoints will explore how sponsors are harnessing the power of Central Statistical Monitoring (CSM) to improve data quality and de-risk their studies.
Discussion points include:
- Risk-Based Monitoring (RBM) – what are the solutions currently being used?
- The sponsor’s view on data quality management using CSM tools
- How can I use Central Statistical Monitoring in my current trial?
- What do I do with the data issues that are identified?
- De-risking the study and complying with industry guidance – tell me more
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
Kostia Franklin, Senior Manager, Clinical Data Management, Cubist Pharmaceuticals
Kostia Franklin graduated from The University of Birmingham, England in 1998. Currently he is working in the position of Senior Manager of Clinical Data Management at Cubist Pharmaceuticals and has over 12 years of CDM experience, both in the UK and USA, within multiple Therapeutic Areas. He is an SCDM Certified Clinical Data Manager and has been playing a leading role in his company’s Data Surveillance initiatives.
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.