This will be the second of two Covance audio conferences dealing with alternative site selection, and will focus on opportunities for the conduct of clinical research in China. This presentation will provide an overview of the current clinical research environment in China and explore reasons why China should be considered as part of global drug development strategies.
Alternative Site Selection: China is presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, of Covance. For more details please visit our site www.fxconferences.com
Showing posts with label Brett Bishop. Show all posts
Showing posts with label Brett Bishop. Show all posts
Monday, August 4, 2008
Thursday, July 24, 2008
Predicting and Preventing Protocol Violations
Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.
This presentation will discuss clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker will examine why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation will look at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.
Finally, the presentation will address the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.
This event is presented by Brett Bishop of Covance. To learn more, please visit www.fxconferences.com.
This presentation will discuss clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker will examine why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation will look at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.
Finally, the presentation will address the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.
This event is presented by Brett Bishop of Covance. To learn more, please visit www.fxconferences.com.
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