7th Annual CROWN Congress

Clinical Research & Operations Worldwide Networking

An Elite Gathering of Clinical Decision-Makers Challenge the Status Quo and Discuss Innovative Approaches and Strategies to Optimize Clinical Operations As the Industry Evolves

January 23-25, 2018  |  Westin Hotel  |  Philadelphia, PA

CROWN provides a comprehensive education on the latest strategies, trends, tools and technologies for optimizing clinical trials and enables you to make the connections necessary to streamline operations and advance. This multi-tracked event is built around topics such as clinical innovation, risk management, outsourcing strategies, operational metrics, risk-based monitoring, relationship building, patient engagement, site performance and clinical data optimization. www.crownclinical.com

Join Avoca for the Following Sessions at the 7^th Annual CROWN Congress:

Wednesday, January 24  |  2:00pm

EFFECTIVE OVERSIGHT STRATEGY

Developing Effective Strategies for Overseeing and Managing the Quality of Clinical Partners to Ensure Performance and Mitigate Risk

• Aligning quality expectations among all stakeholders
• Determining the key elements of an effective oversight plan
• Defining the core elements of a quality agreement
• Crafting strategies and tools for effectively assessing ongoing performance and compliance
• Recognizing the importance of transparency and communication

PRESENTER:

Steve Whittaker Senior Consultant, THE AVOCA GROUP Executive Director, THE AVOCA QUALITY CONSORTIUM

Wednesday, January 24  |  4:00pm

CASE STUDY: CLINICAL QUALITY RISK MANAGEMENT SYSTEM

Examining How a Small Pharma Developed and Implemented a Clinical Quality Risk Management System (CQRMS) to Achieve ICH E6 (R2) Compliance

• Assessing the new requirements for clinical quality operations resulting from ICH E6 (R2)
• Outlining how a small company does an assessment of current clinical operations to determine what must be done to achieve compliance with new regulatory requirements
• Examining the compliance components to develop a strategic CQRMS
• Gaining senior leadership buy-in to effectively mobilize the organization for implementation
• Discussing implementation hurdles and operational challenges and how they were overcome

PRESENTERS:

	Linda Peterson Associate Director, Clinical Operation and Global Integration INOVIO PHARMACEUTICALS
	Karen Roycroft Director, Clinical Quality Assurance INOVIO PHARMACEUTICALS
	Steve Whittaker Senior Consultant, THE AVOCA GROUP Executive Director, THE AVOCA QUALITY CONSORTIUM

Wednesday, January 24  |  11:15am

PANEL DISCUSSION: BREAKING THE OUTSOURCING MOLD

Recognizing the Limitations of the Traditional Outsourcing Model and Developing Innovative Approaches to Optimize Clinical Operations and Maximize Resources

MODERATOR:

• Ed Miseta, Chief Editor, CLINICAL LEADER

PANELISTS:

• Kenneth A. Getz, Chairman, CISCRP; Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
• Patricia Leuchten, CEO, THE AVOCA GROUP
• Mike Martorelli, Emeritus Director, FAIRMONT PARTNERS
• Fabien Sandoval, CEO and Research Director, EMERSON CLINICAL RESEARCH INSTITUTE
• John Whyte, Director Professional Affairs and Stakeholder Engagement, CDER, FDA

DISCUSSION TOPICS:

• Identifying the limitations of the traditional clinical outsourcing methodology and why it isn’t sustainable
• Examining the needs of companies when outsourcing clinical operations to increase effectiveness and what the ideal solution can be
• Evaluating alternative, out-of-the-box outsourcing solutions that address these needs and the feasibility of these models in today’s climate
• Discussing effective outsourcing options for young companies with limited resources
• Driving change to break the current mold and innovate clinical outsourcing

For more information or to schedule a meeting with an Avoca representative, click here.

The Avoca Group is proud to be a Consortium Partner.