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Dinner Short Courses*

Monday, June 1, 6:00-8:30 pm 

(SC1) Facilitating Investigative Sites’ Operational Efficiency: Challenges, Tools, and Methods to Enhance the Clinical Research Enterprise

Karen L. Gilbert, BS, CCRA, Root Cause Research Consulting, LLC  Biography 

David Morin, M.D., RPh, FACP, CPI, Director of Research, Holston Medical Group  Biography 

As the costs of clinical trials rise, clinical research professionals across the industry are under pressure to do more in less time with fewer resources. Today’s research sites face similar challenges, and therefore, need tools and methods to most effectively utilize their resources. This short course will provide the need for operational efficiency tools specifically designed for investigative sites. The goals and components of an effective, data-driven site management strategy will be identified. The speakers will present a novel tool/methodology designed to allow investigative sites to manage resources and performance in a data-driven way. Finally, participants will explore ways in which the site efficiency data derived from this method may be of value to stakeholders across the clinical research enterprise. After attending this session, participants will be able to:

• Discuss the financial viability and operational efficiency challenges facing investigative sites in today’s research environment

• Identify the operational components which sites must track, model, and manage to effectively meet these challenges

• Describe a novel tool and methodology designed to enable data-driven site management decisions

• Explore the potential applications of site efficiency data to facilitate site selection decisions, ensure appropriate monitoring resource allocations, and inform risk-based monitoring strategies

*Separate Registration Required

 Tuesday, June 2, 6:00-8:30 pm 

(SC2) Quality by Design in Clinical Research: Is This Only for the Protocol?

Liz Wool, RN, BSN, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc. Biography 

In the past few years, Quality by Design (QbD) for clinical trials has been communicated and talked about for protocol development and execution. However, translating this QbD approach into “building in quality for the business,” that is increasingly expected of the industry by regulatory agencies, is rarely shared for the “how do I do this?” because organizations state “I believe we are doing this already.” This workshop will de-code and translate QbD and quality for the research enterprise with examples and interactive activities that will solidify the concepts and framework presented for use within any organization. We will discuss:

• Critical first step: defining quality

• QbD: defined and simplified

• What are QbD and Quality Management Systems (QMS)? How do they relate to each other? How do I know if my organization “has these in place”?

• What are “critical to quality” and “critical control points” in QbD, and why are they important?

• Business practices to QbD principles and methods, and approaches to impart QbD where needed

• Going beyond plans and checklists for quality

• Who is involved and responsible for review?

• Strategies for effective implementation

• Effective training of personnel

*Separate Registration Required