This document provides an overview of the Avoca Quality Consortium (AQC), which aims to improve quality management in outsourced clinical trials through collaboration between sponsor and provider companies. The AQC offers members various collaborative activities and tools to harness best practices, including annual summits, workshops, online communities, guidelines, templates and more than 250 leading practices. Member testimonials praise the tangible improvements and shared learning facilitated by the AQC. The summary highlights the consortium's focus areas over time, from quality agreements to risk management to prequalification standards.

1. October 2016
Avoca Quality Consor8um
Improving Proac.ve Quality Management
in Outsourced Clinical Trials

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Mission and Value of The Avoca Quality Consor8um
COLLABORATE
• 65+ companies
• Extensive network of
engaged professionals
• Exclusive annual
summits and mee.ngs
• Dozens of hands-on
workshops
• Aha! Online community,
HARNESS
• 250+ leading prac.ces,
guidelines, and tools
• Mul.tude of Educa.onal
webinars and training
with industry experts
• Access to Avoca’s
leading SMEs
• Exclusive Member
community
DRIVE CHANGE
• Spotlight your
innova.ons
• Proliferate your
best-prac.ces
• Present at industry
conferences
• Lead work-streams and
advisory boards
Join the world’s leading stakeholders from Sponsor and Provider
companies in improving the quality and execu.on of outsourced trials
AXain more sustainable clinical drug development through
a shared plaYorm and common language

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2016 AQC Members: Pharma and Biotech

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2016 AQC Members: CROs and Associate Members
Longboat

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Member Tes8monials
“What sets Avoca apart is Avoca gets things done.
They are efficient in the execu9on and
implementa9on of ideas that we all bring and
develop tools that we can all use and are of value.”
Jeffrey P. McMullen
Chairman, inVen9v Health Clinical and Vice Chairman,
inVen9v Health, Inc.
“This is a place of ac9on to change
behaviors to move the industry for
both sponsors and providers, because
we need both sides of that coin.”
Colleen Glessner
Vice President, R&D Quality and Compliance,
Alexion Pharmaceu9cals
“What I’m really pleased about with the Avoca
Quality Consor9um is that they’ve actually brought
forward tangible improvements and allowed us to
implement these and improve quality in the industry.”
Stephen Cutler, PhD
Chief Opera9ng Office,
ICON plc
“This Consor9um enables me to listen to the
lessons learned and best prac9ces from other
companies, both small and large. The value
here is to speak and define it, and come to
agreement on some key areas around quality.”
Mitchell Katz, PhD
Execu9ve Director, Medical Research Opera9ons,
Purdue Pharma LP
During the October 21, 2015 AQC Members’ Working Session in
Princeton, NJ, Ravi Patel, RPh, PharmD, MBA, Sr. Director, Head of
Global Pharmacovigilance & Drug Safety Opera9ons, Alexion
Pharmaceu.cals, Inc. quoted a comment from an FDA inspector that
followed an inspec.on of their pharmacovigilance program where
AQC tools had been used to oversee outsourced programs…
FDA Inspector Quote:
“This was the most comprehensive
Oversight plan we have seen so far
for pa9ent support programs.”

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Forma.on of
Avoca Quality
Consor.um,
sponsored by
Eli Lilly and Pfizer
Protocol Design and
Protocol Quality
Collabora.ve Approaches to
Inspec.on Readiness
AQC Research: Clinical Trial
Quality from the Pa.ent
Perspec.ve and Member
Percep.ons
2011 2012 2016
Focus on Quality
Agreements and
Quality Metrics
2014 2013
Launch of Effec.ve
Oversight Ini.a.ve
Crea.on of Streamlined
Quality Metrics Taxonomy
and Framework
AQC research on
Risk Management
2015
Research of Member’s
Quality Management
Prac.ces
Proac.ve Risk
Iden.fica.on Tools
QbD Principles
Comple.on of
Prequalifica.on Standards
Launch of Diligent
Collabora.on through crea.on of
AQC Online Community, Aha!
OUR QUALITY JOURNEY

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AQC Portal: Guidelines, Tools and Templates for Quality
Management at Your Finger8ps
*Documents con9nuously updated to stay current with
industry changes and to incorporate Member feedback.

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Guidelines, Tools and Templates for Streamlined Prequalifica8on
of Specialty Service Providers

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Access to 61 Completed RFIs available through Diligent: An
Innova8ve new model for Provider prequalifica8on
Note: 15 Addi.onal RFIs in Progress

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Come Engage With Us!

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Thank you
For addi8onal informa8on please contact
Danya.Burakoff@theavocagroup.com
(609) 759-2856
The Avoca Group
179 Nassau Street, Suite 3A
Princeton, NJ 08542
www.theavocagroup.com