Data capture is no longer the bottleneck, and whether the lag between a signal and a decision shrinks depends on signal design, AI governance, and vendor orchestration.
|Webcasts|April 13, 2021
Best Practices for Building a Successful Clinical Oversight Function
Author(s)Advanced Clinical
*** Tuesday, April 13, 2021 at 11am EDT| 8am PDT | 4pm BST | 5pm CEST *** In this webcast, we will explore best practices for building an effective Clinical Oversight function using a variety of different delivery models. *** On demand available after final airing until Apr. 13, 2022 ***
Register free:
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:
- Learn about the background of clinical oversight, including current global regulations, implications of COVID-19, decentralized trials, and more
- Understand the importance of the sponsor/CRO relationship when executing oversight activities, including the difference between quality vs monitoring vs oversight
- 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
- 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:
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