Avoca s Quality Metrics Consulting Service Offering

Avoca s Quality Metrics Consulting Service Offering

Avoca s Quality Metrics Consulting The Challenge Biopharmaceutical companies and CROs struggle in defining how best to utilize quality metrics to optimize quality outcomes. For some organizations, this means knowing how to measure aspects of quality that are meaningful across global matrixed organizations, and how to eliminate metrics that are not adding value. For others, it means understanding how best to organize and synthesize qualityrelated measurements and associated information so that meaningful, actionable conclusions can be drawn and to achieve improved project outcomes. Many organizations also require improvement in defining the roles, responsibilities, and processes surrounding the assembly, review, and analysis of metrics that will result in the greatest value. These may vary based on an organization s structure and outsourcing model. - Clinical Trials Transformation Initiative definition 2

Avoca s Quality Metrics Consulting The Avoca Solution Effective design, organization, and use of quality metrics to improve clinical trial operations and optimize quality outcomes. Avoca will support your efforts to improve quality outcomes and partnerships by designing a quality metrics framework tailored to your organization and its unique outsourcing/operational model. Avoca will improve your metric-related processes, allowing your organization to get the greatest possible benefit from your metrics collection investment. Avoca consultants will provide you expertise based on 15+ years of industry experience to help get the job done and ensure the most effective use and optimization of quality metrics. Our methodology and approach are outlined in the following slides. 3

Avoca s Quality Metrics Consulting Avoca s Unique Perspective & Experience The Avoca Group formed The Avoca Quality Consortium in 2011, which now brings together 40 member companies (comprised of pharma, biotech, CROs, and specialty clinical service providers) to develop industry standards and leading practices in proactive quality management and risk mitigation in outsourced clinical research. Through our experience and work in the Consortium, Avoca has evaluated many companies quality metrics, including the use and application of quality metrics in clinical development. This provides us with a unique perspective that enables us to provide feedback on an organization s suite of quality metrics. Avoca has developed a taxonomy and framework for quality metrics that is being adopted by top organizations in our industry. All Avoca Senior Consultants have first-hand experience in clinical development and the use of metrics in a clinical setting for biopharmaceutical companies and/or CROs. Avoca has supported top ten pharmaceutical companies with quality metrics consulting. Avoca is able to support a sponsor in conjunction with its CRO partners. 4

Avoca s Quality Metrics Consulting: Approach Avoca s quality metrics consulting is customized based on each organization s unique objectives and challenges, but typically follows a phased approach methodology: Define: Evaluate: Analyze: Identify: Recommend: What are your organization's objectives for the Quality Metrics Program? What is the current approach to measuring quality, who are the key stakeholders and what are their roles? What are the needs and gaps? What improvements will have the greatest impact? Actions, Timeline, and Next Steps 5

Avoca s Quality Metrics Consulting: Deliverables NEEDS ASSESSMENT Summary report that includes the collection of needs information via interviews with key stakeholders. A systematic assessment of your organization s existing metrics and metricsrelated reporting, analysis and review processes. Determines: Metrics Process Efficiency Utility of Metrics for Quality Oversight Quality of Metrics Design Integration of Metrics within the overall QMS GAP ANALYSIS Identification of improvements needed that will have the greatest impact. This may include a technology assessment, which evaluates systems and their utility in meeting quality metric collection, reporting and visualization objectives. IMPROVEMENT RECOMMENDATIONS Strategy document with recommended action plan for process improvement. Avoca s Senior Consultants will facilitate a Strategy Session with key stakeholders to review the information collected, and discuss next steps. 6

Avoca s Quality Metrics Consulting: Needs Assessment Avoca evaluates metrics and processes surrounding metrics. The following are some of the typical areas assessed during this evaluation: Is the distribution of metrics appropriate, offering sufficient but not excessive oversight in all key quality-related outcome and process areas? Are quality metrics organized in such a manner that they can align easily with other sources of quality-related information in order to support comprehensive quality management? Is there clear assignment of purpose of each metric? Are the metrics practical? Is the design of metrics generally appropriate, offering consistent rigor and fit for purpose? Is the suite of metrics organized in a manner that offers sufficient cross-functional and crossmanagement level awareness of and insight into how the organization is performing from a quality management perspective? Is there a clear line of sight from processes being performed to outcomes/value creation? Is there a focus on tasks that create the most value? Have levels of need for metrics been fully identified and are the available reports and roles with respect to review/analysis of quality metrics clear and appropriate according to this structure? Are processes with respect to the population of quality metrics clear, efficient, and effective? Does the suite of quality metrics provide a sufficient balance of leading metrics to ensure the ability to act proactively? Avoca provides supports to our clients in addressing the gaps identified following the Needs Assessment. 7

Avoca s Quality Metrics Consulting: Providing Improvement Recommendations ü Avoca will deliver a Strategy Document, which summarizes specific gaps and needs and outlines overarching recommendations. This is reviewed with key stakeholders during a Strategy Session. ü Avoca will provide an Implementation Plan, which includes actions, next steps and a proposed timeline for change. Avoca will consult with alliance partners/other vendors as part of this process, where appropriate. ü In some cases, Avoca provides a Communication Plan, which outlines a leading practice approach for engaging key stakeholders and communicating changes in a company s quality metrics program. ü Avoca provides Execution Support Services to assist our clients in implementing a new quality metrics program and in support of an organization s change management efforts, if desired. 8

The Avoca Group Client List Alexion Grünenthal Acurian Marken Pharmaceutical/Biotech AstraZeneca BioMarin Boehringer-Ingelheim Bristol-Myers Squibb Cadence Celtic Pharma Centocor Cerexa Cordis CR Bard Cubist Eisai Endo Pharmaceuticals Ethicon Ferring Pharmaceuticals Johnson & Johnson J&J Pharmaceutical Research Development Millennium Novartis Novo Nordisk Ortho Biotech Ortho Clinical Pfizer Purdue Pharma Regeneron Roche Terumo The Medicines Company Vertex Service Providers Aptiv Solutions Beardsworth BioClinica CenterPoint Chiltern Clinical Financial Services CRF Health ERT ExecuPharm Greenphire ICON Clinical Research Idis INC Research Indegene inventiv Health Clinical LabCorp MedAvante Medical Research Consultants Medidata PAREXEL PPD PRA International Quest Diagnostics Clinical Trials Quintiles REGISTRAT-MAPI ResearchPoint Schulman Associates IRB Synarc Theorem TKL Research Worldwide Clinical Trials 9

Contact Avoca at: (609) 252-9020 www.theavocagroup.com Danya.Burakoff@theavocagroup.com 179 Nassau Street Suite 3A Princeton, NJ 08542