De-risking It All – A Systematic and Proven Approach to RBM and Data Quality Oversight

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Drug Discovery & Development, Medical Device, Biomarkers, Medical Device Clinical Trials,
  • Wednesday, April 29, 2015

Learn from industry experts how a unique combination of data analytics and Electronic Data Capture is being harnessed by large, medium and smaller Pharma to de-risk clinical studies and drive Risk-Based Monitoring. This partnership approach will ultimately allow an automated and unsupervised approach to ensure that no stone is left unturned in assessing and improving data quality and, hence, improving patient safety. The webinar will also explore the value of an integrated approach to comprehensive clinical and operational data analysis.

We invite you to challenge our session leaders as to how this can be implemented in your own organization. Leverage a data driven approach and combine both operational and clinical data to identify risks and take pro-active measures to de-risk your study.

The webinar will guide you through how you can combine both your operational risk identification that starts with study planning and operational metrics assessments with the identification of real-time clinical risk that can inform your monitoring plan for a single site, a country, or all sites for a protocol. Learn how the comprehensive offering can influence your risk based monitoring strategy and execution of that strategy during study conduct as teams are provided visibility into clinical risks in real time. Understand how this combined solution can provide evidence for adjustments needed to your monitoring and risk strategy throughout the duration of the study.


James Streeter, Senior Director of Life Sciences Product Strategy, Oracle Health Sciences

James Streeter is Senior Director of Life Sciences Producct Strategy at Oracle Health Sciences. He previously held leadership roles at PPD in both operations, as the Global Head of Global Clinical Technical Operations and EDC, and recently in IT, as Global Head of Systems Development, Business Operations Teams, and eClinical Strategy and Innovation. He has 25 years of data acquisition and analysis experience utilizing computerized systems and has focused on eClinical systems and processes for trials for the last 15 years. His experience includes implementing end to end eClinical Solutions and processes across all therapeutic areas and all phases of studies.

James’ early experience in eClinical was gained at Pfizer Inc., where he was Senior Director of Global Clinical Data Services, heading the global data acquisition department for the company’s global research and development organization. Prior to joining Pfizer, he was a Senior Hardware, Software and Systems Engineer for the U.S. Navy Underwater Sound Laboratory with a focus in data acquisition and analysis.

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Francois Torche, CEO and Chief Information Officer, 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.

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Who Should Attend?

  • Clinical Operations
  • Data Management
  • Biostatistics
  • Quality Assurance
  • Regulatory

Xtalks Partner


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.

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