This document provides the agenda for the Fall 2014 Consortium Members' Meeting. The agenda includes: - Case studies from member organizations on their experiences implementing Consortium best practices and tools - Updates on 2014 initiatives and progress executing projects - Interactive sessions for members to provide feedback on new quality agreement templates and prequalification standards for technical service providers - Discussion of potential focus areas and initiatives for 2015, including leveraging the Consortium for knowledge sharing and transforming quality practices

1. FALL 2014: CONSORTIUM MEMBERS’ MEETING AGENDA
Date: October 7, 2014
Philadelphia Marriott Downtown
Theme 1: Consortium Member experiences with utilization, adaptation, implementation, and
socialization of Consortium best-practice guidelines and tools – Case Studies
Theme 2: 2014 Initiatives – Progress and execution status
Theme 3: Strategies and Focus for 2015
8:30 - 9:00
Registration and Continental Breakfast
9:00 - 10:00
Welcome and Overview of the Day, Brief Introduction of Attendees, Sharing of Consortium Tenets,
Refresher of Consortium Initiatives, and Review of Pulse Survey Results
Patricia Leuchten, CEO, The Avoca Group
Steve Whittaker, Executive Director, Avoca Quality Consortium
Demo: Debbie Briffa, Senior Project Manager, The Avoca Group
10:00 - 12:45
Case Studies (Break Included)
During the Executive Meeting on May 7, 2014, Consortium Executive Sponsors suggested that it would be
beneficial to learn from early adopter AQC Members’ experiences as they have implemented Consortium
tools and initiatives.
10:00 - 10:30
Session 1a: Case Study 1 – Seattle Genetics; Use of the AQC Quality Agreement Template
Marta Fields, Senior Director, Clinical Operations, Seattle Genetics
Seattle Genetics is a biotechnology company located in the Pacific Northwest. With limited
presence outside the US, CROs are used to support global clinical trials. The outsourcing is primarily
functional, although recently Seattle Genetics has begun to fully outsource some studies. A Quality
Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014 1

2. Agreement that would cover either scenario was desired. The modular approach of the Avoca
Quality Agreement toolkit enabled Seattle Genetics to construct a workable Quality Agreement
tailored to our specific needs within a very compressed timeline. Since our preferred partner, PRA, is
also a Member of the Consortium, they were comfortable with the template language and minimal
rework was required.
10:30 - 11:00
Break
11:00 - 11:45
Session 1b: Case Study 2 – inVentiv Health Clinical and Grünenthal GmbH; Development of Quality
Agreement between CRO and Sponsor using the Avoca Quality Agreement Module
Fiona Blurton, MRQA, Senior Auditor, Quality Governance, inVentiv Health Clinical UK Ltd
Joseph Fortunato, Senior Vice President, Corporate Quality Assurance, inVentiv Health Clinical
Ever since the Avoca Quality Consortium completed work in melding together best practices from
a myriad of expert sources, inVentiv Health Clinical was very eager to put into practice the Quality
Agreement Module with a key Sponsor. This presentation and interactive discussion will discuss
inVentiv’s experience in utilizing this module in the joint development of an effective, right-first-time,
Quality Agreement. The discussion will include insight into the use of the Avoca tools and templates,
along with helpful examples of lessons learned between inVentiv and the Sponsor in producing this
final Quality Agreement.
11:45 - 12:15
Session 1c: Case Study 3 – Quality Oversight Best-Practice Tools by Amgen
Anne Merritt, Director of Global Supplier Governance and Clinical Pricing, Amgen
A specific technical issue at a central lab, which impacted multiple studies across a large Phase III
program, will be outlined. This case study will describe how Amgen’s processes and tools were able
to both detect and manage the issue to resolution. Lessons learned will also be shared, including
how this type of issue would be specifically communicated and escalated within Amgen.
12:15 - 12:45
Session 1d: Case Study 4 – Use of Quality Metrics
Mark Penniston, Senior Vice President, Clinical Analytics, Theorem Clinical Research
Management by metrics is a challenge for any organization. As a service provider performing
similar tasks on multiple platforms and systems, defining the data flow and appropriate metadata for
centralized analysis proves to be a greater challenge. Theorem Clinical Research has embarked on
the consolidation of information streams to generate a performance score card based upon Metrics
Champion Consortium published standards. This presentation will describe the challenges and
methodology to consolidate those items, the report services produced for the high level review, and
a planned approach for utilization of the Avoca Quality Consortium metrics taxonomy.
12:45 - 1:45
Networking Lunch
Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014 2

3. 1:45 - 2:30
Post-lunch Challenge Questions
Table Moderators, The Avoca Group
Each participant will be asked to move to another table and pair up with someone they do not know.
They will select a card from a “deck” at each table and take 5 minutes to discuss the topic on Side 1
of the card. Then they will flip the card over and fill in the blank(s) for the item on Side 2 of the card.
Participants will provide brief read-outs of their partnered discussions.
2:30 - 3:30
Session 2: Transforming Supplier Prequalification for the Future - Technical Service Providers Initiative
Deliverables and Next Steps
2:30 - 2:45
Janis Hall, Senior Consultant, The Avoca Group
A short presentation will be provided sharing the progress to date for Phase 0 and Phase 1 of the
Consortium Prequalification Initiative. Significant accomplishments have been achieved by The
Avoca Quality Consortium staff members in partnership with the Prequalification Advisory Board in
establishing Core and Niche Industry Standards, and in developing associated tools (RFI templates,
Score Cards, and Visit Check Lists for the selected specialty service areas: Central Laboratories, IRT
(IVRS/IWRS), Medical Imaging, Biomarker Labs, and ECG Services.
2:45 - 3:30
Table Moderators, The Avoca Group
An interactive working session at group tables will focus on reviewing Prequalification Packages
(Full Set of Standards and Tools): Each table will be provided a matching set of tools and standards
for a technical service (core, central lab, IRT, imaging or ECG). Members will look at the materials as
a “prequalification assessment” package and provide feedback on the strengths and weaknesses
of any of the materials and identify gaps. They will discuss how the new Industry Standards will
benefit industry and their organizations. A debrief session will share their ideas and plans.
3:30 - 3:50
Break
3:50 - 4:15
Session 3: Additional Project News and Updates
3:50 - 4:05
Diligent Project
Patricia Leuchten, CEO, The Avoca Group
Dennis Salotti, Vice President, Operations, The Avoca Group
The Avoca Group has been developing concepts for an expanded Prequalification service being
named “Diligent”. This session will briefly share the vision, concepts, principles, and considerations for
this strategic initiative.
Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014 3

4. 4:05 - 4:15
Quality Metrics and Benchmarking Initiative
Steve Whittaker, Executive Director, Avoca Quality Consortium
Background information will be presented regarding Avoca Quality Consortium Quality Metrics and
perspectives, based on additional research and investigation. An update will be provided on the
metrics database and plans to engage the Executive Forum on October 23 regarding next steps.
4:15 - 4:55
Session 4: Strategies and Focus for 2015
Moderators: Patricia Leuchten, CEO, The Avoca Group
Steve Whittaker, Executive Director, Avoca Quality Consortium
Review of potential 2015 initiatives based on pulse survey and 2014 Consortium Assessment results
Theme 1: Leveraging the Power of the Consortium for Implementation, Knowledge Transfer and Learning,
The Consortium Community
Theme 2: Innovation and Transformation: Protocol Quality through Patient Engagement, QbD Principles,
and Root Cause Solutions
4:55 - 5:00
Close of Event
Avoca Quality Consortium - Members Meeting - Agenda - Oct.7, 2014 4