The document summarizes the 2013 initiatives of the Avoca Quality Consortium, which brings together quality, outsourcing, and operational professionals from pharmaceutical, biotechnology, and clinical research organizations. The Consortium aims to accelerate the development of quality management best practices and industry standards. Key activities for 2013 include finalizing quality metrics and enhancing quality agreement templates based on member experiences, conducting research on proactive quality management, and hosting a Quality Summit focused on ensuring the right balance of timelines, costs, and quality in clinical trials.

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2013 Initiatives
for Proactive
Quality
Management

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● Accelerating the development of best practices and
industry standards for proactive quality management
● Bringing together quality, outsourcing, and operational
professionals from member pharma, biotech, and CROs
● Developing a new paradigm in the industry’s approach to
quality management and partnering to ensure high quality
and risk mitigation
● Led by The Avoca Group
The Avoca Quality Consortium

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● Focus: Helping sponsors and CROs achieve success in the
area of clinical outsourcing
● Practice Areas: Consulting, Survey Research, Training
● Founded in 1999 in Princeton, NJ
Avoca provides their pharma, biotech, and CRO clients with
the strategy and tools to build, measure, manage, and
thereby improve partnering relationships.
The Avoca Group
Avoca History & Overview

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● Increase in clinical outsourcing
● Consolidation of spend with fewer clinical service providers
● Globalization of clinical trials
● Greater protocol complexity
● Industry focus on efficiencies and cost savings
● Increase in the number of high-profile FDA warning letters
Led to the launch of a comprehensive industry
assessment on quality practices in early 2011.
This ultimately led to the formation of the
Avoca Quality Consortium.
State of the Industry
Changes have put pressure on the management of quality

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● The work of the Avoca Quality Consortium is in helping
companies optimize their approaches to proactive quality
management with an emphasis on bringing sponsors and
CROs into greater alignment. Our vision is for the Quality
Consortium to serve as a catalyst for:
╸The acceleration of best practices and industry standards for
proactive quality management
● The initial focus was on the development of a Quality
Agreement template and short list of Quality Metrics. Both
were delivered to Consortium Members in July 2012.
Avoca Quality Consortium
Focus of Consortium

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Avoca Research & Leading Practices
● Avoca Research: Industry-wide
survey and opportunity to
benchmark individual Consortium
companies against larger sample
● Leading Practices: Development of
guidelines, tools, approaches,
standards and templates focused
on proactive quality management
Avoca Research and the development of Leading Practices are the two
pillars of the Avoca Quality Consortium that provide
the foundation for our work.

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● Objective research: Providing insights to individual companies and setting
Quality Consortium priorities
● Leading practices: Optimizing approaches to proactive quality
management
● Collaboration: Pharma companies, biotech companies and CROs
working together to achieve common goals
● Engagement: Member involvement at the Executive as well as functional
level; engagement with regulatory authorities to strive for mutual
understanding and acknowledgement
● Implementation: Operationalizing approaches to proactive quality
management
● Transparency: Sharing of information with other groups, organizations and
industry consortia to ensure no duplication of efforts
● Innovation: Focusing the Consortium’s future priorities on “out-of-the-box”
approaches; leading the way for industry breakthroughs
Consortium Core Tenets

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Consortium
Membership

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Avoca Quality Consortium
Pharma/Biotech Industry Participation to Date
**Roche and Alexion Pharmaceuticals are also Consortium Members

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Avoca Quality Consortium
CRO Industry Participation to Date

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● Access to all Consortium documents via a password protected web portal
including the Quality Agreement template and Quality Metrics documents
(delivered to Members in 2012)
● Avoca Research Reports, the Consortium Assessment aggregate report
and a benchmarking report focused on quality practices tailored
specifically for your company
● 2013 Guidelines for Proactive Quality Management; definition of terms;
processes, approaches, roles, skills, structures, and tools for effective
oversight
● Assessment results focused on Prequalification Visits and Routine Audits of
clinical suppliers
● Participation (for two attendees) at the May 2013 Quality Summit and Fall
Working Sessions; company participation in the Consortium WebEx
Meetings
Quality Consortium Member
Summary of Benefits

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● Increased collaboration between pharma/biotech and CROs
resulting in:
╸Improved quality and greater predictability
╸Simplification of processes; reduced duplication
╸Reduced cost
╸Mitigation of risk
╸Exchange of information
╸Improved relationships
╸Greater respect for each other’s obligations
╸Innovative and efficient solutions
Quality Consortium Member
Summary of Benefits (continued)

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Plans and Focus
Areas for 2013

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2013 Focus
● Helping our Members
achieve the right balance
between meeting timelines,
ensuring cost containment,
and achieving the highest
level of quality

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2013 Core Activities
Finalization and Refinement of 2012 Deliverables
● Continue research to finalize quality metrics
● Further enhancement of quality agreement based on member
experiences
2013 Consortium Research and Leading Practices
● Continued focus on proactive quality management and effective
oversight of outsourced projects
● Provision of core concepts, guidelines, and practical tools
● Opportunity for collaboration through consortium meetings
Forward-looking High Priority Initiatives
● Identification of areas for innovations building on existing work and
future Consortium initiatives

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● Guidelines and tools for Proactive Quality Management and effective
oversight
● Analysis of individual company’s approaches to proactive quality
management and effective oversight while keeping company-specific
information confidential
● Research results that outlines industry approaches to prequalification of
full-service CROs and niche providers
● Complete assessment on approaches to assessing and managing risk;
aggregate report and individual benchmarking report
● Refined work in the area of Quality Metrics and the joint Quality
Agreement template
● Assessments of technology enablers and strategies for operationalizing
approaches for proactive quality management
● Peer networking and sharing of best practices with consortium members at
bi-annual Quality Summit
2013 Deliverables

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2013
Avoca Quality
Summit

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This conference focuses around the theme of Ensuring the Right
Balance between Time, Cost, and Quality in this Changing
Regulatory Environment. Avoca data not presented in other public
forums will provide the basis for the Summit.
● May 8th meeting is a closed meeting for Members only
● May 9th is open to the industry
2013 Quality Consortium Summit
Event Co-Chairs:
● Jeffrey Kasher, PhD
Vice President, Clinical Trial:
Materials, Implementation, and
Transformation
Eli Lilly and Company
● Christopher J. Hilton
Vice President, Development &
Clinical Alliance Management
Pfizer Development Operations

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● Risk Assessment and Risk Management in Outsourced
Clinical Trials – The 2013 Avoca Report with a focus on state
of the industry and best practice approaches
● Two-part session on creating a culture of quality and
change management strategies for ensuring success
● Strategies for Ensuring Effective Oversight
● Industry "Call to Action": top areas and industry initiatives
that could make a significant impact in terms of achieving
greater efficiency while ensuring high quality
2013 Quality Consortium Summit
Summit Key Topic Areas

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Summit Sponsor:
Supporting Sponsors:
2013 Summit Sponsor Companies

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The Avoca Group, Inc.
179 Nassau Street
Suite 3A
Princeton, NJ 08542
609-252-9020
For information regarding new membership
for Avoca’s Quality Consortium,
please contact Danya Burakoff
Danya.Burakoff@TheAvocaGroup.com
For existing members,
please contact Caryn Laermer
Caryn.Laermer@TheAvocaGroup.com