Best Practices for Building a Successful Clinical Oversight Function

Register free: http://www.appliedclinicaltrialsonline.com/act_w/clinical_oversight

Event Overview:
Clinical oversight contributes to the success of global trials by ensuring the protection of trial participants as well as the integrity of the data collected. Global regulators are increasingly seeking more formal documentation of sponsor oversight activities during inspections.

Sponsors who are not involved in their clinical oversight processes, or who follow informal documentation strategies, run the risk of inspection findings (e.g., FDA-483) that can cause delays, fines, and potentially impact regulatory approvals. When sponsors choose to outsource this critical function, the pros and cons must be carefully considered.

Key Learning Objectives:

In this webcast you will:

1. Learn about the background of clinical oversight, including current global regulations, implications of COVID-19, decentralized trials, and more
2. Understand the importance of the sponsor/CRO relationship when executing oversight activities, including the difference between quality vs monitoring vs oversight
3. Learn best practices for sponsors who are planning c linical oversight activities but may be unsure whether keeping this function in-house is more efficient than outsourcing
4. Explore how sponsors can leverage alternative delivery models to help mitigate risks and streamline processes

Speakers: Nan Croy, Director of Functional Service Solutions, Advanced Clinical

Melissa Mauriber, Vice President, Clinical Operations Quality & Talent Development, Advanced Clinical

Sponsor: Advanced Clinical

Time and Date: Tuesday, April 13, 2021 at 11am EDT| 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing until Apr. 13, 2022

Register free: http://www.appliedclinicaltrialsonline.com/act_w/clinical_oversight