This webinar focuses on some of the advantages and takeaways learned so far from the introduction, implementation, and adoption of decentralized clinical trials (DCTs). Panelists explore how they operationalized best practices in the areas of budgeting, contract language, remote monitoring practices, virtual visits, and more.
Dive into an overview of both the ICH E9 Guideline on Statistical Principles for Clinical Trials from the International Council for Harmonization and the ICH E9(R1) Addendum, exploring how clinical trials are based on statistical principles and how treatment effects are measured.
Take a deep dive into the roles and functions of Data Monitoring Committees/Data Safety Monitoring Boards (DMCs/DSMBs) and Endpoint Adjudication Committees/Clinical Events Committees (EACs/CECs) in the lifecycle of clinical trials. These committees are increasingly tasked with providing independent, expert evaluations of clinical trial events and unbiased adjudications to determine if the definitions of certain clinical trial events have been met.
This webinar provides a review of the purpose of and expectations set for holding an Investigational New Drug (IND) application through the U.S. Food and Drug Administration, explores common IND-related errors and how to avoid them, and outlines related requirements found in 21 CFR 312 of the Code of Federal Regulations for IND maintenance.
This webinar examines the communication of intent and expectations to stakeholders in clinical trials to minimize risk and gain fluidity in operations, along with key elements behind planning a clinical trial and best practices for budgeting a study.