How to realize the efficiency benefits of ICH E6 (R3) before it’s released
From Craig Morgan on April 1st, 2021
ICH 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.