Since the initial publication of the ICH GCP guidelines, the way clinical trials operate has changed significantly. The ICH E6 (R2) addendum, which came into effect in June 2017, encourages sponsors to develop a prioritized, risk-based approach to monitoring. However, despite the guidance, some sponsors are still unclear on how to achieve the “gold standard” for monitoring, study execution and oversight.
This Autumn, Industry RBM experts from CluePoints and HighPoint Solutions, will be visiting Copenhagen, Basel, and Cambridge, to share their experience of how a pragmatic approach to RBM can enable success. These events will present practical, case-based methods for addressing the challenges of RBM.
During the events, we will review what’s needed from a people, process and technology standpoint to adopt a risk-based approach to study execution, featuring:
- The key updates to the ICH E6 GCP.
- How to drive ICH E6 (R2)
- Why RBM is necessary for clinical studies & the benefits that can be derived from a centralized approach to monitoring.
- The value in aggregating study data to make better decisions (e.g. Quality Tolerance Limits), based on industry metrics
- Best practice for study planning and execution, including pre-study risk assessment.
- How to assess the effectiveness of your clinical technology and processes.
- How to manage the change in your organization
- Case studies that illustrate the benefits of using an automated statistical approach.
- Our vision of RBM for the next 5 years
- Companies that use some sort of approach to RBM and are looking to do more.
- Those that are new to RBM and want to understand the value better.
- Experienced users of RBM that are looking at the future of Data Analytics – what’s next?
Monday, October 1, 2018 – Basel Switzerland
09:00 AM – 12:30 PM
Hotel Le Trois Rois, Blumenrain 8, 4001 Basel, Switzerland
Wednesday, October 3, 2018 – Copenhagen, Denmark
09:00 AM – 12:30 PM
Hotel Bella Sky, Center Boulevard 5, 2300 Kobenhavn, Copenhagen, Denmark
Thursday, October 4, 2018 – Cambridge, UK
09:00 AM – 12:30 PM
Hotel Felix, Whitehouse Lane, Huntingdon Road, Girton, Cambridge, CB3 0LX
To register for one of the events, click the “register now” button underneath this paragraph. Upon submitting your registration, you will receive an automated email that includes all of the event specifics.
