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.
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).
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.
This webinar addresses the challenges of transforming clinical research operations with technology built during the upheavals research sites underwent in the midst of COVID-19 disruptions. You will gain a better understanding of the technology evolution experienced by the clinical research enterprise, how best to future-proof operations to avoid future disruptions such as this, and tips for operating your site with a view of both short- and long-term goals.
This webinar describes how a research site’s electronic health record (EHR) data can be used to precisely identify potential subjects from its patient population, thus reducing recruitment and screening efforts and accelerating time to completion of enrollment. Involved are the use of eConsent to enroll patients from their homes, the collection and use of relevant real-world data extracted from the EHR in ways that eliminate certain study visits and manual data entry, and the use of eSource for cutting the need for source data verification.