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2015 Initiatives for Proactive Quality

Management

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

Design

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

collaborate

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

Management

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

Tools

Phase One Phase Zero Phase Two

Avoca Quality Consortium

Drive Industry

Credibility

Define Core Qualification

Criteria

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

Forums

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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

Education

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The Avoca Group, Inc. 179 Nassau Street

Suite 3A Princeton, NJ 08542

609-252-9020

For more information please contact:

Danya.Burakoff@TheAvocaGroup.com

Caryn.Laermer@TheAvocaGroup.com