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Register Today!October 10, 2013

Risk-Based Monitoring

Speaker for this Event:
  • Mark Travers, VP, Head of Clinical Study Units, Sanofi-Aventis    
  • Effective monitoring of clinical investigations is critical to the protection of human subjects and the conduct of high-quality studies. Clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA.

    During the past two decades, the number and complexity of clinical trials have grown dramatically. These changes create new challenges to clinical trial oversight, particularly increased variability in clinical investigator experience, site infrastructure, treatment choices, and standards of health care.

    This webinar will cover the following with in-depth discussion on:

    1. Ensuring the rights, safety of trial subjects
    2. Data integrity & management
    3. How much monitoring of clinical trial sites is necessary to ensure quality, compliance, and safety of research participants
    4. How to go from 100% source data verification to a risk-based monitoring
    5. Increasing the effectiveness of clinical trial site monitoring
    6. Cost reduction and improved data quality

    A live Q&A with the audience will follow the main presentation.

    Register Today!

    VPs, Directors, Department Heads, Managers, Principal Scientist involved in:

    • Clinical R&D
    • Clinical Operations
    • Clinical Projects, Programs & Data
    • Regulatory Affairs

    Mark Travers, VP, Head of Clinical Study Units, Sanofi-Aventis

    Born and educated in Glasgow, Scotland, Mark Travers holds an Honors Degree in Biochemistry and a PhD in Bio-engineering from the University of Strathclyde in Glasgow. He also completed 2 years of post doctoral research in chronic and acute renal failure at the royal Infirmary in Glasgow and earned an MBA in general management from the University of Sussex in Brighton.

    Mr. Travers moved to Wuppertal (Germany) in 1988 to work with the fibers and Polymers division of Enka (an Akzo company) in the area of clinical Research and Scientific Marketing.

    In 1990 he moved to London as a Clinical Research Associate (CRA) with Yamanouchi working on an alpha blocker for BPH. Now lunched in the US as FlowMax.

    In 1992 Mr. Travers joined the Janssen Research Foundation (Johnson & Johnson) as a senior Project Manager working in the areas of CNS, Neurology and Pain control. He progressed through various management positions to reach the position of R&D Director for the UK, Ireland and Israel and a position on the UK Management Board.

    In 2001 Mr. Travers moved to Johnson & Johnson in the US as Head of Global Trial Management for the Global Clinical Operations organization responsible for training and managing Global Trial Managers (GTMs) who in turn managed all of the Phama’ groups clinical trials from Phase 1 through to Phase IV. In 2006, he was promoted to the position of VP, Head of Clinical Trial and Site Management for the Americas Region – Canada, US and Latin America.

    In 2010 Mr. Travers moved to Sanofi to take up the position of VP, Head of the Clinical Study Units. The CSU organization sits within the Clinical Sciences and Operations platform of Sanofi R&D. The CSU consists of over 1700 people in over 40 countries managing and monitoring clinical trials in over 70 countries.

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