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