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The Complete Integrated Risk-Based Monitoring (RBM) Solution:

Harnessing the Power of Multiple Technology Systems to Drive RBM and Overall Data Quality Oversight

WEBINAR DETAILS

Date: January 21, 2016

Featured Speakers:
  • James Streeter, Vice President of Life Sciences Product Strategy, Oracle Health Sciences
  • Francois Torche, CEO and Chief Information Officer, CluePoints

Join CluePoints and Oracle Health Sciences, to learn from two market leaders about an optimal way to get actionable results from the comprehensive analysis of clinical and operational data. Whether you are just starting your RBM journey, have conducted pilots, or are looking to ramp up your RBM more efficiently, this webinar will:

  • Showcase an integrated RBM technology solution that seamlessly ties together multiple data sources and platforms
  • Provide insight as to how sponsors are using RBM technology as part of their new approach to monitoring
  • Demonstrate the ease with which sponsors and CROs can adopt a comprehensive central monitoring platform
  • Discuss how best to harness the power of a joint approach to deliver real value to your organisation
  • Walk you through the ultimate RBM approach:
    • Risk Assessment and Planning (using the RACT)
    • Determination of risk mitigation plans and Key Risk Indicators (KRIs)
    • Study analytics and actionable issues
    • Overall Data Quality Oversight
    • Machine learning techniques to standardise future process

Keywords: Risk-Based Monitoring, Multiple Technology Systems

      ABOUT OUR SPEAKERS

      James Streeter

      James Streeter, Vice President of Life Sciences Product Strategy, Oracle Health Sciences


      James Streeter is Vice President of Life Sciences Product 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.

      Francois Torche

      François 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.

      THIS PROGRAM IS INTENDED FOR
      • Clinical Operations
      • Data Management
      • Biostatistics
      • Quality Assurance
      • Regulatory
      OUR XTALKS PARTNER FOR THIS EVENT

      CluePoints
       

      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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