2015 Initiatives for Proactive Quality Management. Progress through Collaboration

Transcription

1 2015 Initiatives for Proactive Quality Management Progress through Collaboration 1

2 2015 AQC Members 2

3 The Avoca Quality Consortium Accelerating the development of leading practices and industry standards for proactive quality management Bringing together quality, outsourcing, and operational professionals from Member pharma and biotech companies, CROs, and specialty clinical service providers Developing a new paradigm in the industry s approach to quality management and partnering to ensure high quality and risk mitigation Led by The Avoca Group Avoca provides their pharma, biotech, and CRO clients with the strategy and tools to build, measure, manage, and thereby improve partnering relationships. 3

4 Avoca Research & Leading Practices Avoca Research and the development of Leading Practices are the two pillars of the Avoca Quality Consortium that provide the foundation for our work. 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 4

5 Consortium Core Tenets 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 Consortium s future priorities on out-of-thebox approaches; leading the way for industry breakthroughs 5

6 Overview of

7 Summary of 2015 Initiatives, Educational Opportunities, Research and Meetings Ø 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 Ø 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 Ø 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 Ø AQC Survey Research Quality Management Systems/Framework Focus on Protocol Quality Ø AQC Meetings May 6, Annual Quality Summit; Princeton, NJ Fall Working Session (Date TBD) Fall Executive Meeting (Date TBD) 7

8 AQC Community Ø The AQC will focus on leveraging the power of Membership and collaboration by creating a platform for sharing experiences and communicating information. Ø 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. Ø 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 8

9 AQC Community Ø 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 9

10 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: ü ü ü ü 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 10

11 Prequalification Project- Phased Implementation Plan Phase Zero Avoca Quality Consortium Phase One Avoca Quality Consortium Phase Two Avoca Quality Consortium Drive Industry Credibility Define Core Qualification Criteria Obtain Expert Input Convene Advisory Board Develop Core industry Standards and Tools Target 5 high risk Technical Services Increase Efficiency Create Technical Prequalification Standards and Tools Develop Expert Reviewed Standards and Tools Develop Prequalification Tools (RFI s, Score Cards, Visit Check Lists) for 4 high risk Technical Services Reduce Costs for Prequalification Visits and Mitigate Risk Share Information (Standards and Tools) Develop Portal- for use as a document repository; in 2015 expand to more Technical Services 11

12 Overview of 2015 Associate Member Benefits 12

13 Quality Consortium 2015: Benefits Leading Practices Access to Avoca Quality Consortium Community Portal Avoca Quality Agreement template and Quality Metrics document: revisions and refinements Prequalification of technical service providers: Development of standards and sharing of information based on a phased approach AQC Portal Screenshot 13

14 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: 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 14

15 Quality Consortium 2015: Benefits Consortium Research New Members will also receive aggregate reports from previous AQC 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 15

16 Quality Consortium 2015: Benefits Consortium Meetings and Forums 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. 16

17 Quality Consortium 2015: Benefits Education 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 17 th 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 17

18 The Avoca Group, Inc. 179 Nassau Street Suite 3A Princeton, NJ For more information please contact: 18