Panel: Risk-Based Approach to Trial Management & the TMF

Session details:

Traditionally, managing a TMF involves a labor-intensive process of reviewing each document meticulously, however, a shift towards a risk-based management approach has been gaining momentum. In this session we will explore the benefits to a risk-based approach and how to implement it effectively.

• Learn how to identify and prioritize high-risk documents to direct resources to those that truly matter provides greater efficiency with a Risk-Based approach
• Understand how to optimize your resources in a risk-based approach which allows for faster cycle times and reduced operational costs
• Discuss the benefits of handling compliance issues and risks promptly to safeguard the integrity of the trial and ensure patient safety through a risk-based approach
• Examine best practices for implementing an effective Risk-Based Management Process
• Consider leveraging an eTMF to better implement a risk-based approach