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

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Monday, October 30, 2017

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


Rob Nichols, Chief Commercial Officer, Director, Algorics

Rob Nichols is Chief Commercial Officer and Director of CROS NT’s technology partner, Algorics, having worked at Imperial Collage as a Medical Statistician and subsequently held senior commercial roles at Quintiles, Phase Forward and Oracle.

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Giulia Zardi, Biostatistician, CROS NT

Giulia Zardi has been a biostatistician in CROS NT since 2014. Thanks to a double degree program, she possesses a Bachelor’s of Science degree in Statistics obtained from the University of Glasgow and the University of Bologna in 2011. She also holds a Master’s degree in Statistics from the University of Bologna and completed her master thesis in biostatistics at the University of Chicago in 2013. Giulia gained experience working on Phase II-IV studies as well as observational studies in several therapeutic areas such as Neurology, Psychiatry, Respiratory, Ophthalmology. She has also been a crucial member of the team developing CROScheck – a clinical analytics platform allowing biometrics oversight for Risk-Based Monitoring which includes a Centralized Statistical Intelligence element.

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Who Should Attend?

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


  • Senior Clinical Project Managers
  • Quality Assurance Professionals

Xtalks Partner


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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