What causes the widespread variance in site performance in clinical trials, declining data quality and missed timelines? What can drug development service providers and sponsors proactively do to optimize site performance?
A large percentage of clinical trial budgets is allocated to fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors. This audio conference discusses protocol violations as a consequence of stressed environmental conditions at investigative sites. The presentation looks at why these violations are so pervasive, and the inability of conventional measures to adequately detect and address them. The speaker then discusses how protocol violations are preventable within a risk management paradigm, and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).
Optimizing Site Performance: Risk Planning vs. Remediation is being presented by Pam Atwell, Director, Operational Strategies and Planning, of Covance Clinical Development Services and airs Thursday, Dec. 4, 2008. For more details or to register, please visit our site www.fxconferences.com
