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Applying ICH GCP E6(R2) Guidelines to All Aspects of Clinical Trials


Date: Monday, October 30, 2017

Time: 12pm EDT

Duration: 90 minutes

Featured Speaker:

How to establish a risk-based monitoring approach; create an independent assessment of the integrity of data coming in from sites; reduce patient risk; and reduce monitoring costs. [Applicable to Sponsors only]

The ICH GCP E6(R2) addendum represents the biggest change in GCP guidelines in over 20 years and they have been in effect since June 2017. The FDA guidance for industry and the EMA reflection paper encourage greater reliance on centralized monitoring practices. 100% SDV is not required or expected by the FDA. Additionally, it is limited in its ability to provide insight into data trends across time, patients and clinical sites. The guidelines highlight that you can use a more comprehensive statistical approach to interrogate data. They also state that the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.

In this webinar, data-driven CRO, CROS NT, will explain:

  • How Sponsors can conduct independent verification of the quality and integrity of the data collected from sites
  • How to further minimize risk for patients
  • How to optimize costs through more efficient monitoring
  • How to detect trial misconduct
  • How to meet regulatory requirements and follow guidelines related to taking a risk-based approach and interrogation of data

The webinar will provide a case study and focus on three key areas::

  1. Risk Management Metrics
  2. Centralized Statistical Intelligence
  3. Data Visualization and Analytics

Keywords: Clinical Trials, ICH GCP E6(R2), Risk-Based Monitoring


    Mark Paul, President North America, CROS NT

    Mark has served in progressive management positions in the clinical trials industry for over 24 years. He began his clinical research career in the CRO environment as a programmer and project manager and served in project management, business development, and information technology functions. Mark was Project Director for several NDA submissions and global clinical trials, and he has served as department head of data management, clinical operations, and business development groups as well as Director, eClinical Technologies for a major CRO. In addition, Mark occupied the role of CEO of StatWorks, Inc., a data and biometrics focused CRO, for over 8 years. In his most recent role before joining CROS NT, Mark was a Managing Partner and head of sales and marketing for Veracity Logic. He holds an MBA from the Kenan-Flagler School of Business at UNC-Chapel Hill and a BA from the College of William and Mary in Virginia.


    VPs/Directors/Department Heads working within:

    • Biometrics and Data Services and Analytics
    • Clinical Operations and Development
    • eClinical/Information Technology
    • Clinical Trial Study/Protocol Managers
    • Medical Writing
    • Outsourcing and Strategic Alliance
    • Regulatory and/or Submissions
    • Statistics and Programming

    The webinar will provide a case study and focus on three key areas:

    • Senior Clinical Project Managers
    • Quality Assurance Professionals


    Founded in 1992, CROS NT is a data-driven Contract Research Organization (CRO) providing services from feasibility to clinical study reporting for Phases I-IV and medical device trials. CROS NT's services include regulatory consultancy, monitoring, data management, biostatistics programming & analysis, pharmacovigilance and medical writing and accompanying eClinical applications (data visualization, EDC, IWRS, eCOA/ePRO etc.). All services are underpinned by strong clinical and biometrics project management with offices located in Europe, the USA and India.

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