CH E6 (R3) is coming at a time when life science organizations still are struggling to adopt ICH E6 (R2). But should organizations wait until these guidelines are ratified to realize the intended benefits?

The recently released ICH E8 (R1) draft, a precursor to this new guidance provides the answer, specifically calling for establishing a culture that supports critical thinking and open dialogue about quality that goes beyond sole reliance on tools and checklists.

Applying critical thinking during study startup is pivotal to improving study conduct overall. Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance and audit-readiness, and in order to avoid serious budget and timeline overages. These issues can derail a study resulting in costly rescue interventions, often due to issues that are preventable.

In this on-demand webcast we will explore:

• The intended purpose of ICH regulations—to implement industry best practices, and not to add additional burdens on clinical research staff.
• What organizations stand to gain from adopting the updated guidelines, versus the compliance and other costs they’re likely to incur.
• How by applying critical thinking to risk management, organizations can improve their operational efficiencies by minimizing duplicate quality-assurance steps.
• Strategies for quick, relatively straightforward adoption of the new guidelines.

This on-demand webcast is applicable to:

• Sponsor and CRO roles who are responsible for:
  • Site identification, feasibility assessment, selection and activation
  • Clinical data management, collecting and evaluating trial metrics
  • Project management of studies and operational excellence