Research and Expanded Access in Pandemic Times

This webinar provides an overview of the mechanisms through which, in pandemic conditions, experimental COVID-19 therapies and diagnostics were made available to patients and providers before clinical trials had established whether those products were safe and effective. Also considered are how this state of affairs affected researchers’ ability to generate substantial evidence of product effectiveness through high-quality trials and the U.S. Food and Drug Administration’s deliberations over potential COVID-19 vaccines.

Good Clinical Practice (GCP) Simulation

The New Standard in GCP Training. This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).

Transforming SOP Infrastructure for COVID Times (Session II)

This second of two webinars on best practices in crafting standard operating procedures (SOPs) for clinical trials applies the concept of emotional quotient-based design thinking to appropriately draft SOPs that include all potential stakeholders. Also considered will be common blind spots within basic compliance mechanisms and the keys for drafting more adaptive SOPs to serve as reference tools and training materials for preparing your organization for new ways of conducting clinical trials.