Chapel Hill, NC, USA (23 October 2017) – In a live broadcast taking place on Monday, October 30, 2017 at 12 pm EDT industry expert CROS NT will host a Webinar to explain how to apply ICH GCP E6(R2) guidelines to all aspects of clinical trials.
It will cover how to meet ICH E6(R2) addendum guidelines, enable Risk-Based Monitoring, increase Sponsor’s oversight of data coming from sites and minimize workload.
The ICH GCP E6(R2) addendum represents the biggest challenge 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 should 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, CROS NT will discuss:
- 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 include a case study and focus on three key areas:
- Risk Management Metrics
- Centralized Statistical Intelligence
- Data Visualization & Analytics
The speakers for this webinar will be CROS NT biostatistician, Giulia Zardi, and Chief Commercial Officer (Algorics), Rob Nichols.