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.
Presenting a discussion on how consolidating the processes involved in the phases of drug discovery, pre-clinical research, clinical trials, and post-approval expectations on a single platform drives efficiencies, margin improvements, and real-time collaborations internally and externally. The result is better top- and bottom-line financial performance and consistency in process outcomes during trial execution.