A large percentage of clinical trial budgets is allocated to fix problems after they occur instead of proactive activities to predict and prevent errors. There are several factors causing the widespread variance in site performance in clinical trials, declining data quality and missed timelines. What can drug development service providers and sponsors do to proactively optimize site performance?
Protocol violations are a consequence of stressed environmental conditions at investigative sites and are extremely pervasive. Conventional measures won’t adequately detect or address them. This audio conference discusses and details 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 was presented by Pam Atwell, Director, Operational Strategies and Planning, with Covance Clinical Development Services and aired on 2008-12-04. For more details, or to download this audio conference, please visit our site at www.fxconferences.com
