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The Avoca Quality Consortium (AQC) provides leading practices for the optimization of proactive approaches to achieving quality and mitigating risk in clinical trials and programs. Sponsored by Eli Lilly and Pfizer and led by The Avoca Group, AQC brings together 70 pharma, biotech, and clinical service companies that share a commitment to collaboratively improving the execution and management of outsourced trials.

Members have access to a large, growing repository of over 250 leading practice tools, guidelines, and standards that deliver meaningful improvements to the speed, efficiency, and quality of clinical trial execution, plus the means to track and influence the development of innovative new approaches.

As the only consortium focused on quality management in clinical outsourcing that engages both Sponsors and CROs in improving quality, reducing risk, and breaking down silos, AQC is uniquely well placed to align executives in open and pre-competitive dialogue while also engaging operational leaders to make tangible improvements to the execution of clinical trials.


 

AQC Timeline, History, & Deliverables


2011

SO IT BEGINS

  • Meeting with FDA to discuss 2011 industry research on quality of outsourced trials
  • Formation of Avoca Quality Consortium, sponsored by Eli Lilly and Pfizer

2012

EARLY INITIATIVES

  • Quality Agreement template
  • Launch of Quality Metrics work
    • Identification of gaps, insight
  • Report of Consortium Member quality practices and approaches

2013

REAL WORLD APPLICATIONS

  • Quality Metrics Taxonomy and Framework
  • Eight-element framework for Proactive Quality Management and Effective Oversight
  • AQC Research on Risk Management
  • Industry approaches to prequalification and routine systems audits of full-service CROs and niche providers

2014

A GROWING BODY OF WORK

  • Quality Oversight Guidelines & Tools
  • Standards for Prequalification of Technical Service Providers
  • Proactive Risk Identification Tools and QbD Principles
  • Study-level Quality Metrics
  • Research of Members’ Quality Management Practices
  • Research with investigative sites focused on quality and clinical trial execution (in collaboration with SCRS)

2015

ACHIEVING POSITIVE MOMENTUM

  • Collaboration through creation of AQC Online Community, Aha!
  • Finalized Standards for Prequalification of Technical Service Providers
    • Eight Specialty Areas
  • Robust Quality Management Framework
  • Protocol Quality Principles
  • Finalized Study-level Quality Metrics
  • Benchmarking research on Quality Management Systems

2016

TRACTION AND LEVERAGE: REAL PROGRESS THROUGH COLLABORATION

  • Leading Practice Approaches to Protocol Design and Protocol Quality
  • Partnered, Collaborative Approaches to Inspection Readiness
  • Formation of Leadership Circle
  • Quality Oversight Framework, Guidelines and Tools
    • Expansion and refinement of Leading Practice Documents
  • Quality Metrics Framework, Taxonomy and Study Level Metric
    • Implementation Case Studies
  • Prequalification of technical service providers initiative
    • Refinement of standards and tools for the eight specialty areas completed
    • AQC Member Access to Diligent Centralized RFI information
  • AQC Research: Clinical Trial Quality from the Patient Perspective and Member Perceptions
  • 350+ Operational and Outsourcing Professionals Collaborating through Private Online Community, Aha!

2017

REACHING OUR POTENTIAL

  • Inspection Readiness Knowledge Center
  • Patient Engagement Playbook
  • ICH E6 R2 Tool Mapping
  • Oversight Capability Maturity Model (OCCM)
  • AQC Research on Risk: Understanding the methods used to assess and manage risk in outsourced clinical trials
  • 1,000+ Members collaborating through Aha!
  • >6,500 Leading Practice Documents downloaded over the last 12 months via the AQC Knowledge Center

2017 AQC Members


Benefits of Membership


Practical solutions and standards for proactive quality management, increased collaboration between pharma/biotech, CROs, and niche clinical service providers.

  • Company assessment and benchmarking against Avoca’s large industry sample on risk management.
  • Access to the Avoca Quality Consortium Community Portal for sharing ideas, collaborating with colleagues in other companies, and for access to information.
  • 250+ Comprehensive Guidelines and tools for Effective Quality Oversight Quality Agreement template & core set of quality metrics.
  • The Avoca Group reports and publications on quality and trends in clinical outsourcing.
  • Participation in the annual Summit and two member Fall Meetings.
  • Participation in educational webinar series.

For more information on membership, contact:

Danya Burakoff

Danya Burakoff

Director, Client Development

(609) 759-2856

AQC Research & Additional AQC Programs


AQC Research

  • 2017 AQC Research on Risk Management with an emphasis on risk-based approaches to oversight and quality management
  • 2016 Patient Survey
  • 2016 Research on quality-promoting practices
  • 2015 Research focus on Quality Management Systems and Protocol Quality
  • 2014 Research of Consortium Members’ quality management practices
  • 2014 Research with investigative sites focused on quality and clinical trial execution (in collaboration with the SCRS)
  • 2013 AQC research on Risk Management
  • 2013 Industry approaches to prequalification and routine systems audits of full-service CROs and niche providers
  • 2012 Report of Consortium Member quality practices and approaches

Additional 2017 AQC Programs

  • Guidance, support, and tools to empower Members to understand, prepare, and comply with ICH E6 (R2)
  • Knowledge Center on Inspection Readiness
  • A playbook on Patient Engagement (incorporating work on protocol quality)

Aha! Online Community

Aha! is a confidential, collaborative environment in which AQC Members exchange ideas and information on a wide range of topics related to measuring, managing, and improving quality in clinical trial execution.

Tap into the collective intelligence of the Avoca Quality Consortium

  • Find information to progress your individual and company quality goals
  • Share an idea and help others make their ideas  become reality
  • Read timely articles
  • Learn about the latest AQC developments
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Member Portal

The AQC Member portal is a place for Members to download the wealth of information published by AQC. Over 230 Quality Oversight Guidelines and Tools, including

  • Quality Agreement Template
  • Quality Metrics and Taxonomy
  • QbD Principles and Tools
  • Risk Management Framework and Tools
  • The portal also includes Prequalification Standards for Technical Service Providers, Webinars, Case Studies, and AQC Research
Discover More
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AQC News & Events


AQC 2017 Fall Meeting

Save the date: October 25, 2017 | New Brunswick, NJ

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2017 Summit Europe

Save the date: June 7-8, 2017
Dublin, Ireland

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