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).
This audio conference covers:
- Approaches and tools for improved site profiling and selection
- The main drivers of preventable errors at the site level
- How to shift resources from error remediation to primary data quality and proactive risk management
- The impact of the FMEA approach on clinical trial budgets and performance
About the speaker:
Pamela H. Atwell is Director of Operational Strategies and Planning with Covance Clinical Development Services. In this role, she designs evidence-based study plans, study engineering and study governance and collaborates with business development and operations. In addition, she provides associated training and coaching to the project teams on aspects pertaining to project strategy, including risk and contingency planning.
Ms. Atwell has more than 15 years of experience in clinical research, progressing from Senior CRA to Project Manager and Project Director. As a Project Director with Covance, she managed global Phase II and III multi-center studies in several therapeutic areas. She also supervised project teams, tracked timelines and budgets, and coordinated all project-related activities among the clinical, data management, medical writing, and biometrics departments to ensure operational excellence. Ms. Atwell received her BA in Psychology from the University of Virginia.
Who should attend?
- Senior Management
- Clinical Development
- Clinical Operations
- Regulatory Affairs
- R&D
- Project Management
- Outsourcing
*This conference is rated General interest.