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ExL’s 8th CROWN Congress

January 22-24, 2019  |  Hilton Orlando Lake Buena Vista  |  Orlando, FL

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.

In 2019, the 8th Crown Congress will expand on last years conference by highlighting and addressing relevant topics impacting today’s’ clinical trials’, such as clinical innovation, risk management, outsourcing strategies, operational metrics, risk-based monitoring, relationship building, patient engagement, site performance and clinical data optimization.


Receive a 15% discount off the standard pricing with code AVOCA.

Can not be applied to group discounts.


Join Avoca for the following sessions:

















Wednesday, January 23 – 11:15am-12:15pm

[SENIOR LEADERS PANEL] Exploring Clinical Operations and Resources: Where are Clinical Trials Headed for 2019?

Moderator:  Dennis Salotti, MS, MBA, CCRA, Chief Operating Officer, The Avoca Group


  • Jim Kremidas, Executive Director, The Association of Clinical Research Professionals
  • Manny Lazaro, Vice President, Head of Clinical Operations, Jounce Therapeutics
  • Karim Damji, SVP Product Management and Marketing, Saama
  • Michelle Shogren, Director of Innovation – Pharma R&D Clinical Operations, Bayer
  • Leesa Gentry, Sr. VP, Infectious Disease, Evotec

Key topics:

  • Explore the impact of the Clinical Outsourcing Model
  • Touch on quality relationships and risk-based approaches
  • Hear some of the changes in the regulatory landscape
  • Stage of clinical outsourcing, risk assessment risk-based approaches and how to manage quality and oversight
  • Clinical Research Site Professionals on Clinical Trial Conduct Quality
  • Clinical Trial Quality and Performance
  • Risk-Based Monitoring: Explore key factors and changes when applying risk-based monitoring for a study
  • Risk-Based Monitoring for Operationally Complex Studies: Opportunities for improved quality and flexibility, ICH E6 (R2) for clinical research the use of mobile technology in clinical trials successfully
  • Incorporating mobile technology in regulatory submission trials
  • Global Clinical Trials: Explore real challenges with global trials







Wednesday, January 23 – 1:30pm-2:15pm

[PRESENTATION] Simplifying Vendor Selection and Qualification with Standards and Centralized Approaches

Speaker: Jay A. Turpen, Senior Consultant, The Avoca Group

  • Review ICH E6 (R2) requirements for Vendor Qualification and the current Industry practices
  • Examine current Pharma company approaches to Vendor Identification, Qualification, and Ongoing Quality Management
  • Investigate areas of risk and inefficiency inherent in current practices
  • Explore opportunities to significantly simplify Vendor Identification, Qualification, and Quality Management via standards and centralized approaches while removing bottlenecks that slow down drug development teams











Thursday, January 24 – 10:45am-11:30am

[PANEL DISCUSSION] Improve the Working Relationship Between the Site, CRO, and Sponsor

Moderator:  Janis Hall, MBA, Senior Consultant, The Avoca Group


  • Reginald Hooks, Associate Director, Clinical Operations, Acadia Pharmaceuticals
  • Gloria I-Hsuan Jen, M.S., PMP, Director of Clinical Operations, SRI Biosciences, Clinical Trials and Strategic Development Services
  • Jim Kremidas, Executive Director, The Association of Clinical Research Professionals
  • Aryn Knight, Clinical Research Oversight Specialist; Assistant Administrative Director, Texas Heart Institute

Key topics:

  • Review how communication can create a multitude of challenges for each party
  • Learn how to tackle the issues with inclusion/exclusion criteria to ensure the most successful recruiting
  • Connect ways to identify any operational challenges within the protocol that might be obstacles to the trial


To schedule a meeting with an Avoca representative at this event, contact us.


Webinar: Site/Sponsor/CRO Dynamics: Driving Quality and Productive Relationships Access the Recording and Slides >>