The document provides an agenda for the Avoca Quality Summit on May 6, 2014. The overall theme is "Progress through Collaboration – Breaking Down Silos, Advancing Technology, and Building Bridges to Patients". The agenda includes sessions on reducing risk and improving quality in clinical trials through prequalification of third parties, presenting results from a member assessment survey, breakout groups to discuss quality guidelines and tools, enhancing quality metrics and benchmarking, and a discussion on using big data to inform clinical trial execution.

1. 1Avoca Quality Summit – Agenda – May 6, 2014 #AQCSummit2014
Overall Theme: Progress through Collaboration – Breaking Down Silos, Advancing Technology,
and Building Bridges to Patients
10:30 AM - 11:00 AM
Registration and Continental Breakfast
11:00 AM - 11:20 AM
Welcome and Overview of the Day
•• Introduction, agenda and objectives
• Patricia Leuchten, CEO, The Avoca Group
11:20 AM - 12:20 PM
Session 1: Reducing Risk, Improving Quality, and Enhancing Efficiency in the Identification and Selection of
Third Party Providers
11:20 am – 12:00 pm
• This session will share the approach and progress being pursued by the Avoca Quality Consortium
to initiate a process for Prequalification of third party organizations. Concepts include easy, central
access to RFI and qualification information for critical to quality (CTQ) parameters for high-risk data
generating niche-services.
• Janis Hall, Senior Consultant, The Avoca Group
12:00 pm – 12:20 pm
• Moderated Consortium group discussion
• Steve Whittaker, Executive Director, Avoca Quality Consortium
The Westin Princeton at Forrestal Village
201 Village Boulevard
Princeton, NJ 08540
AGENDA
MAY 6TH
2014

2. 2Avoca Quality Summit – Agenda – May 6, 2014 #AQCSummit2014
12:20 PM - 1:20 PM
Lunch
1:20 PM - 2:00 PM
Session 2: Consortium Member Assessment Results
• This session will share interim results from the 2014 Avoca Quality Consortium Member Assessment
Survey, which examines trends in perceptions of quality in outsourced clinical trials, and in the
practices used to oversee quality-related aspects of such trials. This year’s survey report will provide
longitudinal analyses comparing 2014 results to data from previous Consortium assessments.
• Dr. Denise Calaprice-Whitty, Senior Consultant, The Avoca Group
• Moderated Questions/Answers
• Steve Whittaker, Executive Director, Avoca Quality Consortium
2:00 PM - 3:00 PM
Session 3: Consortium Member Breakout Sessions
2:00 pm – 2:15 pm
• Pre-Breakouts: This session will provide a “walk-through” of the Avoca Quality Consortium Quality
Oversight web portal, highlighting QbD tools and sharing how they may be used and tailored for
specific needs
• Debbie Briffa, Senior Project Manager, The Avoca Group
• Janis Hall, Senior Consultant, The Avoca Group
2:15 pm – 3:00 pm
Parallel Breakouts
• Breakout 1 (Tables will be provided case situations for use in locating and accessing guidelines/
tools): Member-led discussions of experiences working with the Quality Consortium best-practice
Quality Oversight Guidelines and Tools, Quality Agreement Template, and Technology Enabler which
provides access to Consortium Member documents. The session will be structured as an interactive
session, with sponsor Members and CRO Members working together on a topic, question or an issue
related to the tools.
• Breakout 2: Moderated Executive Meeting
3:00 PM - 3:20 PM
Break
3:20 PM - 4:20 PM
Session 4: Quality Metrics and a Focus on Enhancing Outcomes
3:20 pm – 3:45 pm
• This session will share the refinement and enhancement of the Consortium metrics taxonomy and
framework to ensure a comprehensive set of metrics that are likely to have measurable impact to
the outcomes for quality in clinical programs. The presentation will provide information regarding
progress with the Consortium’s metrics benchmarking study and database, including methods of
measurement and reporting for specific metrics.
• Dr. Denise Calaprice-Whitty, Senior Consultant, The Avoca Group

3. 3Avoca Quality Summit – Agenda – May 6, 2014 #AQCSummit2014
3:45 pm – 4:05 pm
• Breakout Groups – Seven preset metrics groups (based on each person’s stated interest when
completing the morning registration) will move to assigned tables and discuss the metrics framework
and develop feedback.
• Avoca Staff migrate around tables to assist discussions
4:05 pm – 4:20 pm
• Moderated Consortium group discussion and metrics feedback
• Steve Whittaker, Executive Director, Avoca Quality Consortium
4:20 PM - 5:20 PM
Session 5: Data and Potential for “Big Data” to Inform Decisions in Clinical Trial Execution
• This session will be an interactive discussion regarding the use of “big data” to inform decisions in
clinical trial execution. The session will start with the presentation of Avoca’s 2014 industry data and
then will proceed to an interactive discussion with experts at PatientsLikeMe.
• Avoca 2014 Industry Data presented by Dr. Denise Calaprice-Whitty
• Interactive discussion led by Jeremy Gilbert, Vice President of Product and Strategy, and
Matthew K. Scott, Manager, Business Development & Strategy, PatientsLikeMe
5:20 PM - 5:30 PM
Wrap - Up and Closure
6:00 PM - 8:00 PM
Dinner sponsored by
Tre Piani
120 Rockingham Row
Princeton, NJ
Thank you to our gold summit sponsor