WebeX Presentation - Quality Consortium
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Overview of the Avoca Quality Consortium
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WebeX Presentation - Quality Consortium
- 2. 2 Today’s Discussion ● Brief overview of The Avoca Group ● Background on the formation of the Avoca Quality Consortium ● Quality Consortium overview including approach and deliverables to date ● Current focus areas
- 3. 3 Client List The Avoca GroupPharmaceutical/Biotech AstraZeneca Ferring Pharmaceuticals BioMarin Grünenthal Boehringer-Ingelheim Johnson & Johnson Bristol-Myers Squibb J&J Pharmaceutical Research Development Cadence Celtic Pharma Millennium Centocor Novo Nordisk Cerexa Ortho Biotech CJPCUS Ortho Clinical Cordis Pfizer CR Bard Purdue Pharma Cubist Regeneron Eisai Roche Endo Pharmaceuticals Terumo Ethicon The Medicines Company ServiceProviders Acurian Marken Aptiv Solutions MedAvante Beardsworth Medical Research ConsultantsBioClinica Clinical Financial Services Metropolitan Research Associates CRF Health PAREXEL ERT PPD ExecuPharm PRA International Greenphire Premier Research ICON Clinical Research Quest Diagnostics Clinical Trials Idis Quintiles INC Research REGISTRAT-MAPI Indegene ResearchPoint inVentiv Health Clinical Synarc Theorem LabCorp TKL Research
- 4. 4 Avoca’s Practice Areas CONSULTING ● Relationship and Alliance Management ● Planning and Implementation of Strategic Outsourcing Initiatives ● Quality Management and Quality Metrics RESEARCH SERVICES ● Partnership Assessments ● CRO Performance ● Lessons Learned Surveys ● Investigative Site Surveys ● Needs Assessments TRAINING ● Art and Science of Partnering™: Effective Management of CRO Partnerships The Avoca Group
- 5. 5 Avoca Vision To be the catalyst for positive transformation in the relationships between sponsors and CROs. Expanded Vision for Avoca and the Quality Consor9um: To enable posi,ve partnering rela,onships as a way to transform clinical trial execu0on with a focus on improving quality. Intent is to address areas of dysfunc,on and focus on areas of highest need. Goals: achieving greater efficiency, shortened 5melines, and higher quality.
- 6. 6 State of the Industry and the Role of the Avoca Quality Consortium
- 7. 7 State of the Industry ● Increase in clinical outsourcing ● Consolidation of spend with fewer clinical service providers ● Globalization of clinical trials: increase in number of studies in less-experienced developing regions ● Greater protocol complexity ● Industry focus on efficiencies and cost savings ● Increase in the number of high-profile FDA warning letters Led to the launch of a comprehensive industry assessment on quality practices in early 2011. This ultimately led to the formation of the Avoca Quality Consortium. Changes have put pressure on the management of quality
- 8. 8 Companies are “siloed” in their approaches. Industry interest in sharing, collaboration and moving toward industry standards. Context for the Avoca Quality Consortium 1. Disconnects exist between sponsors and CROs in the perceptions of the quality of outsourced clinical trials 2. Low levels of satisfaction with “proactive” approaches ╸ Governance of quality ╸ Communications surrounding quality 3. Higher levels of satisfaction are reported in areas that could be considered “reactive” approaches to quality management ╸ Compliance with SOPs and other written procedures ╸ Audit plans and execution 4. Correlation among companies taking a best practice approach to proactive quality management and high levels of satisfaction with quality and outcomes Key takeaways from 2011 Avoca Research on Quality
- 9. 9 Vision: To accelerate the development of best practice approaches and industry standards for the proactive quality management of outsourced trials. Corporate Sponsors: Avoca Quality Consortium
- 10. 10 Avoca Research & Leading Practices ● Avoca Research: Gathering of quantitative and qualitative data from Members; provision of aggregate data and individual benchmarking reports. ● Leading Practices: Development 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.
- 11. 11 Avoca Quality Consortium Pharma/Biotech Participation to Date
- 12. 12 Avoca Quality Consortium CRO Participation to Date
- 14. 14 Avoca Approach to Developing Leading Practices Tailor Refine Combine Supplement Member Reviews Edit Adapt Best Practices Concepts Descriptions Details What/How Tools Select Read Interpret Assess Extract Discuss Review Documents Presentations Interviews Meetings Collect
- 16. 16 53% 52% 47% 42% 40% 33% 27% 21% 20% 18% 15% 14% 11% 4% 25% 26% 35% 29% 33% 20% 22% 33% 15% 24% 36% 23% 23% 5% 21% 12% 11% 10% 23% 16% 10% 12% 17% 20% 17% 33% 27% 32% 9% 15% 32% 32% 29% 29% 67% 50% 25% 3% 8% 20% 11% 7% 6% 20% 36% 38% 18% 37% 17% 18% 22% 20% 15% 5% 12% 17% 30% 4% 8% 14% 16% 29% 41% 20% 13% 0% 20% 40% 60% 80% 100% J E A C M L H K B Q D G P N I F O -All- Always Often Sometimes Rarely Never Company: N 19 31 17 12 10 18 15 33 25 11 13 22 19 24 17 9 10 305 How often do your teams use written Quality Agreements to establish and document quality expectations in outsourced clinical trials? Variability of use within individual member companies
- 17. 17 Quality Agreement- Fundamental Elements
- 18. 18 2012 Quality Agreement Deliverable 2013 Quality Agreement Modules In 2013 We Delivered A New Modular Agreement QA Template • Primary Module 1 • Primary Module 2 • Primary Module N Functional Module 1 Functional Module 2 Functional Module N Supplemental Detail Text 1 Supplemental Detail Text 2 Supplemental Detail Text N High Level QA Template Supplemental Functional Sections Supplemental Detail Text
- 21. 21 Making Sense of Consortium Metrics ! ! ! ! ! ! ! ! ! ! ! ! ! Adequate!protec-on!of!subjects’! rights!! ! ! ! Adequate!protec-on!of!subjects’! safety/welfare! ! Scien-fically!valid!and!ethically! !sound!(parsimonious)! experimental!design! ! Integrity!of!data! ! ! ! !! Execu-on!of!study!per!protocol! FOUNDATIONS!!FOR!!ENSUREING!QUALITY! Outcomes!(ul-mate!“report!card”)! Frac4on!of!studies!achieving!passable!levels! Process!quality! (Does!process,!when!followed,!lead!to!desired!outcome?)! Process!Adherence!! (Is!process!being!followed?)! Enterprise!Management! Integrity!of!data!analysis!and! interpreta-on! ! ! !! Adequacy!of!documenta-on!of!all!aspects!of!study! Contributors!Predictors!Outcomes! Quality!Metrics:!Three!Categories! Basis!for!Quality!Metrics! !•!!!Protocol!will!answer!intended!scien4fic!ques4on! !•!!!Protocol!compliance!is!achievable! !!•!!!Pa4ents!not!exposed!to!any!more!risk!than!necessary! !•!!!Minimize!unnecessary!procedures! •!!!Qualified!Inves4gators! •!!!100%!of!subjects!“evaluable”!for!analysis! !•!!!Compliance!with!protocol!procedures! !•!!!Integrity!of!randomiza4on!and!of!the!blind! !•!!!Integrity!of!inves4ga4onal!product! !•!!!Sufficient!subject!reten4on! ! ! ! ! ! CATEGORY! OPTIMAL!OUTCOME! No!GCP/regulatory!viola4ons! • All!subjects!consented!appropriately! throughout!study! • Ethics!approvals! • Appropriate!medical!care! !!!!!!!!!No!GCP/regulatory!viola4ons! !•!!!Qualified!safety!reviews!and!inves4gator/pa4ent! ! !!!!!!!no4fica4on!performed!promptly! !•!!!Integrity!of!inves4ga4onal!product! ! ! ! ! ! Database!provides!100%!accurate!reflec4on!of! study!experience! ! ! ! ! ! Data!analysis!is!sta4s4cally!valid,!free!of!errors,!and! interpreted!by!qualified!personnel.! ! “Quality”: “The ability to effectively and efficiently answer the intended question about the benefits and risks of a medical product or procedure while assuring patient safety and protection of human subjects.” Clinical Trials Transformation Initiative definition
- 23. 23 Eight Elements of Effective Oversight Governance/Organizational Construct Technical/Project Oversight Process Oversight Communication Metrics/Analytics/Technology Roles/Responsibilities Oversight Leadership Requirements Proactive Risk/Opportunity Management
- 24. 24 Define Plan Lead Decide Deliver Measure Eight Elements of Effective Oversight Governance / Organizational Construct Technical / Project Oversight Process Oversight Communication Oversight Leadership Requirements Metrics / Analytics / Technology Roles / Responsibilities Proactive Risk / Opportunity Management Proactive Quality Management
- 25. 25 Quality Oversight Framework Governance/ Organizational Construct Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Technical/ Project Oversight Functional Project Team Business Technology Process Oversight Delegated Processes Shared Processes QbD Principles QMP Process Development/ Improvement Communication Communication Communication Plan Escalation Plan Oversight Leadership Requirements Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Metrics / Analytics / Technology Leading Indicators KPIs KQIs Desktop On- Demand Real Time Accuracy Roles / Responsibilities Sponsor Oversight Sponsor Operations CRO Oversight CRO Operations Proactive Risk / Opportunity Management Risk Identification Risk Management Opportunity Management Quality Risk Plans Timeline Risk Plans Cost Risk Plans Recovery or Transition Plans Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Communication Communication Plan Escalation Plan Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Technical/ Project Oversight Functional Project Team Business Technology Process Oversight Delegated Processes Shared Processes QbD Principles QMP Process Development/ Improvement Communication Communication Plan Escalation Plan Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Metrics / Analytics / Technology Leading Indicators KPIs KQIs Desktop On- Demand Real Time Accuracy Roles / Responsibilities Sponsor Oversight Sponsor Operations CRO Oversight CRO Operations Proactive Risk / Opportunity Management Risk Identification Risk Management Opportunity Management Quality Risk Plans Timeline Risk Plans Cost Risk Plans Recovery or Transition Plans Governance/ Organizational Construct Governance Sourcing Models Committee Construct Decision Models Ctrs of Excellence Teams/Functions Quality Units Issue Escalation Communication Communication Communication Plan Escalation Plan Oversight Leadership Requirements Leadership Leadership Styles Oversight Leadership Characteristics Talent Management Planned for comple,on in 2014 Process Selection Completed In Development
- 26. 26 Operationalizing Proactive Approaches to Quality Management and Oversight Process Oversight Guideline* • Process Tool-‐1-‐ Elements of Process Oversight • Process Tool-‐4-‐ Quality by Design Principles • Process Tool-‐1a-‐ Task Ownership Matrix • Process Tool-‐4a-‐ QbD for Pharma GMP Ac9vi9es • Process Tool-‐1b-‐ Template Task Ownership Matrix • Process Tool-‐4b-‐ QbD for Pharma GCP Ac9vi9es • Process Tool-‐2-‐ Transfer of Regulatory Obliga9ons • Process Tool-‐4c-‐ Opera9onalizing QbD for Clinical Trials • Process Tool-‐2a-‐ Template Transfer of Regulatory Obliga9ons • Process Tool-‐4d-‐ QbD Template CTQ Table • Process Tool-‐3-‐ Process Document Control • Process Tool-‐4e-‐ QbD Template IMP Interven9on Risk • Process Tool-‐3a-‐ Process Tracking Table • Process Tool-‐4f-‐ QbD Template Design and Methods Risk • Process Tool-‐3b-‐ Joint Process Development • Process Tool-‐4g-‐ QbD Template FMEA • Process Tool-‐3c-‐ Six Sigma SIPOC Tool • Process Tool-‐4h-‐ QbD Best Prac9ces when Outsourcing • Process Tool-‐3d-‐ Six Sigma Swim Lane Tool • Process Tool 4i-‐ QbD Supplier Risk Assessment • Process Tool-‐3e-‐ Template for Joint Process Documenta9on • Process Tool-‐5-‐ Joint Quality Management Plan • Process Tool-‐3f-‐ Process Improvement • Process Tool-‐5a-‐ Supplier Assessment Report Template • Process Tool-‐3g-‐ Lean and Kaizen Events • Process Tool-‐5b-‐ Central Supplier Assessment Tracking Table • Process Tool-‐3h-‐Root Cause Analysis • Process Tool-‐5c-‐ Project Supplier Tracking • Process Tool-‐3i-‐Template RCA Fishbone Diagram • Process Tool 5d-‐ Approved Supplier List • Process Tool-‐3j-‐Sta9s9cal Process Control-‐ Control Chart • Process Tool-‐6-‐ Change Management Best Prac9ces • Process Tool-‐3k-‐Process Mapping Instruc9ons • Process Tool 6a-‐ Change Management Plan Template Completed In Development Planned Launched early
- 28. 28 Online Library: Swim Lanes
- 29. 29 Online Library: Decision Making Module Docs
- 30. 3030 Overview for 2014 “Progress through Collaboration”
- 31. 3131 ● Overview of 2014 Leading Practices – Focus Areas: 1. Quality Oversight Guidelines - Detailed Tools and Templates 2. Proactive Risk Identification Tools and Quality by Design Principles 3. Prequalification of niche suppliers – development of standards and sharing of information based on a phased approach 4. Study-level Quality Metrics – refinement of existing work; provision of standards Quality Consortium 2014: Overview Leading Practices
- 32. 3232 2014 Leading Practice: Pre-qualification Initiative ● An initiative will be launched in 2014 focused on sharing information, increasing efficiency, and ultimately reducing costs in the prequalification of niche providers. The 2014 work will include: ╸ Gathering of information and approaches from Members ╸ Definition of Critical To Quality factors and criteria for high priority, data-generating niche providers ╸ Creation of standards: o RFIs o Criteria for prequalification ╸ Development of technology solution for housing and sharing information ╸ Future strategy development based on Member input (see preliminary Phased Implementation Plan) Leading Practices
- 33. 3333 Develop Process and Tools • Service-specific RFI templates and scoring tools • White paper case studies: define vendor qualification process best practices via industry (Consortium Members, health authorities) Share Information • Implement process: Providers respond to RFI • RFI interviews/defense/ qualification visits • Portal transparency- data documents • White paper: process and outcome (anonymous) Centralize Prequalification • Rigorous accreditation process developed based on Industry/ Member input • Niche suppliers accredited via a standard, centralized process Reduce Costs for Prequalification Visits and Mitigating Risk Obtain Expert Input • Target 2 or 3 high risk data-generating niche services • White paper: define CTQ factors /criteria via industry (Consortium Members, niche providers, health authorities) Increase Efficiency with the RFI Process Create standards for Prequal visits Phased Implementation Plan (2014/2015) Phase OnePhase Zero Phase Two Phase Three Planned for 2014 Potential for 2015 and beyond Drive Industry Credibility Define robust qualification criteria Improve Quality through Accreditation of Niche Suppliers
- 34. 3434 ● 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) Quality Consortium 2014: Overview Consortium Research
- 35. 3535 ● The Avoca Quality Consortium will hold Member forums and webinars designed to: § Promote collaboration and alignment between sponsors and CROs § Address areas of dysfunction in proactive quality management § Enable sharing of information between Members § Obtain feedback and solicit input on Leading Practices § Instruct operational staff in best practice approaches § Identify future focus areas ● Reports and publications on quality and trends in clinical outsourcing published by The Avoca Group ● Monthly Member Newsletters Quality Consortium 2014: Overview Education
- 36. 3636 ● Participation for two attendees at the Annual Quality Consortium Summit (May 6-7, 2014 in Princeton, NJ) ● Participation for two attendees at the Fall Members Working Session ● This small working session is designed for operational staff and focused on Consortium leading practices. ● Invitation for one Senior Executive to attend the Executive Forum ● This interactive meeting is designed to discuss and determine future Consortium Strategy. Quality Consortium 2014: Overview Consortium Meetings and Forums
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- 38. 3838 THANK YOU!