Avoca Quality Consortium Associate Membership Overview

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1 2015 Initiatives for Proactive Quality Management “Progress through Collaboration”

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    2015 Initiatives for Proactive Quality


    Progress through Collaboration

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    2015 AQC Members

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    Accelerating thedevelopment of leading practices and industry standards for proactive qualitymanagement

    Bringing together quality, outsourcing, and operational professionals from Member pharma and biotech companies, CROs, and specialty clinical service providers

    Developing anew paradigm in the industrys approach to quality management and partnering toensure high quality and risk mitigation

    Led by The Avoca Group

    The Avoca Quality Consortium

    Avoca provides their pharma, biotech, and CRO clients with the strategy and tools to build, measure, manage, and thereby

    improve partnering relationships.

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    Avoca Research & Leading Practices

    Avoca Research identifies industry gaps and leading-practice approaches, provides insights to our Members and serves as the basis for decision-making on Consortium strategy.

    Leading Practices: Development and adoption 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 Consortiums future priorities on out-of-the-box approaches; leading the way for industry breakthroughs

    Consortium Core Tenets

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    Overview of 2015

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    AQC Community Community Portal development, launch and management Sharing Case Studies and Members engaging with each other Introduction of new and refinement of existing leading practices

    Prequalification of technical service providers 2015 Focus Areas: PRO/ePRO and Bioanalytical Laboratories 2014 Focus Areas: Core Standards, Medical Imaging, Central Labs, ECG, IRT and

    Biomarker Labs

    Participation in 2015 Educational Webinar Series Risk Assessment/Management Utilization of On-line Communities Prequalification Standards and Processes Protocol Quality/Constraints and Opportunities for Patient-centricity in Clinical Trial


    AQC Survey Research Quality Management Systems/Framework Focus on Protocol Quality

    AQC Meetings May 6, 7 2015 Annual Quality Summit; Princeton, NJ Fall Working Session (Date TBD) Fall Executive Meeting (Date TBD)

    Summary of 2015 Initiatives, Educational Opportunities, Research and Meetings

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    The AQC will focus on leveraging the power of Membership and collaboration by creating a platform for sharing experiences and communicating information.

    Through the AQC Community Portal, Members will have the opportunity to ask questions of each other and of Avoca. Avoca will use the platform to orient Members to existing leading-practice documents, our research and, to introduce new ideas and approaches.

    The intent and objectives for the online AQC Community are to: Enhance and expand opportunities for AQC networking and information

    sharing beyond the existing Member Summit and Working Meetings

    Provide a mechanism for companies to socialize forward-thinking approaches to quality management within their companies

    Develop a vehicle for learning, personal growth, and enrichment Create a secure, effective (and fun) platform for our Members to


    AQC Community

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    Key topics in areas of greatest interest to Members will be explored via the AQC Community Platform. These include: Implementation of proactive approaches and tools at the team level. Case Studies on use of AQC tools Member experiences with taking a holistic approach to Quality


    Collaboration regarding protocol quality Communication and collaboration surrounding Quality Metrics;

    incorporation of the AQC taxonomy/framework and AQC Metrics into existing metrics programs

    Risk assessment and management leading practices

    AQC Community

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    Prequalification Initiative: Overview and Plans for 2015

    The goal of this initiative: to address the current dysfunction in prequalifying specialty clinical providers by creating industry standards and tools.

    Objectives: Reduce costs for sponsors, CROs, and specialty clinical providers Shorten timeframes for onboarding specialty clinical suppliers Improve efficiency through the sharing of tools and information Reduce risk in the conduct of clinical trials through improved decision

    making, based on a thorough approach, detailed information, and comprehensive standards

    2015 Focus Areas: PRO/ePRO and Bioanalytical Laboratories 2014 Focus Areas: Core Standards, Medical Imaging, Central Labs,

    ECG, IRT, and Biomarker Labs

    Focus of 2015 Work: Continue engagement with Advisory Board Members and specialty providers for input

    Build upon existing core standards and taxonomy; further refinement of existing tools White paper and webinars focused on Technical Industry Standards

    Expand into additional specialty areas for the development of industry standards and tools

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    Avoca Quality Consortium

    Reduce Costs for Prequalification

    Visits and Mitigate Risk

    Prequalification Project- Phased Implementation Plan 2014

    Develop Expert Reviewed Standards

    and Tools

    Develop Prequalification Tools (RFIs, Score Cards, Visit Check Lists) for 4 high risk Technical Services

    Share Information

    (Standards and Tools)

    Develop Portal- for use as a document repository; in 2015 expand to more Technical Services

    Obtain Expert Input Convene Advisory Board

    Develop Core industry Standards and Tools

    Target 5 high risk Technical Services

    Avoca Quality Consortium

    Increase Efficiency

    Create Technical Prequalification Standards and


    Phase One Phase Zero Phase Two

    Avoca Quality Consortium

    Drive Industry


    Define Core Qualification


    2014 2014-2015

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    Overview of 2015 Associate

    Member Benefits

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    Access to Avoca Quality Consortium Community Portal Avoca Quality Agreement template and Quality Metrics

    document: 2013-2015 revisions and refinements

    Prequalification of technical service providers: Development of standards and sharing of information based on a phased approach

    Quality Consortium 2015: Benefits

    Leading Practices

    AQC Portal Screenshot

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    Quality Management Systems evaluation of how teams are managing quality across project portfolios Sub-topics include: socialization and

    communication; company culture; organizational change; association with risk mitigation and governance

    Protocol Quality assessment of process for protocol development and ensuring protocol quality Sub-topics include: incorporation of the patient

    perspective in protocol development; assessing patient and implementation risks at the protocol development stage

    Quality Consortium 2015: Benefits

    Consortium Research

    Members receive an Aggregate report of the AQC research as a key deliverable. Key topics for 2015 research include:

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    Quality Consortium 2015: Benefits

    Consortium Research

    2014 Research of Consortium Members quality management practices

    2014 Benchmarking initiative focused on Study-level Quality Metrics

    2014 Research with investigative sites focused on quality and clinical trial execution (in collaboration with the Society for Clinical Research Sites)

    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

    New Members will also receive aggregate reports from previous AQC Research

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    Participation for two attendees at the Annual Quality Consortium Summit (May 6-7, 2015 in Princeton, NJ) This annual meeting brings together 150+ senior-level executives

    working in clinical operations, outsourcing, and quality from sponsor, CRO, and specialty clinical service providers to discuss leading practices used in proactive quality management in clinical research. The 2015 theme is on the intersection of quality and clinical trial innovation.

    Participation for one attendee at the Fall Members Working Session This meeting brings together representatives from each

    Consortium Member company to exchange experiences with utilization, adaptation, implementation, and socialization of Consortium leading-practice guidelines and tools. The meeting is designed to be interactive with a focus on the progress and execution status of 2015 initiatives.

    Invitation for the CEO or Senior Executive to attend the Executive Forum One Senior level executive from each Member organization

    attends this meeting to set the strategic direction for 2016 Avoca Quality Consortium initiatives.

    Quality Consortium 2015: Benefits

    Consortium Meetings and


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    The AQC educational webinar series is designed to address areas of dysfunction in proactive quality management, enabling sharing of information between Members and to discuss leading-practice approaches. Topics include:

    Prequalification Standards and Processes Feb 11 at 10 am EST & Feb 17th at 1 pm EST

    Clinical Program Risk Assessment and Management Utilization of On-Line Communities to Advance

    Collaboration, Networking, and the Utilization of Leading Quality Management Practices

    Multi-Stakeholder Discussion: Protocol Quality and Constraints and Opportunities for Patient-centricity in Clinical Trial Design

    Access to AQC reports and publications on quality and trends in clinical outsourcing published by The Avoca Group

    AQC Monthly Member Newsletters

    Quality Consortium 2015: Benefits


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    The Avoca Group, Inc. 179 Nassau Street

    Suite 3A Princeton, NJ 08542


    For more information please contact:

    [email protected]

    [email protected]