Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.

However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.

Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.

This audio conference covers:

• Recognizing and prioritizing early warning signals that trials are at risk of veering off course, and proactively mitigating risks
• Assessing preventative strategies to manage the impact of environmental, regulatory and clinical changes
• Understanding the need for shifting resources from error remediation to investing in primary data quality and proactive management of risk

About the speaker:

Susan Schenk currently provides senior leadership in the development and implementation of the operational platform for Covance Clinical Development Services. Her position involves collaborating with business development and operations, through the design of evidence-based study plans, study engineering and study governance. In addition, she provides associated training and coaching to the project teams on aspects pertaining to project strategy, including risk and contingency planning.

Ms. Schenk has more than 14 years of experience in clinical research. Before becoming a Director in Operational Strategy & Planning, she held progressive positions as senior CRA, project manager and project director. Ms. Schenk received her BA from Samford University in Birmingham, AL.

Who should attend?

• Clinical Operations
• Project Management
• R&D
• Outsourcing