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1
Overview of
Avoca Quality
Consortium
2
Today’s Discussion
● Brief overview of The Avoca Group
● Background on the formation of the Avoca Quality
Consortium
● Q...
3
Client List
The Avoca GroupPharmaceutical/Biotech
AstraZeneca Ferring Pharmaceuticals
BioMarin Grünenthal
Boehringer-Ing...
4
Avoca’s Practice Areas
CONSULTING
●  Relationship and
Alliance Management
●  Planning and
Implementation of
Strategic Ou...
5
Avoca Vision
	
  
	
  
To be the catalyst for positive
transformation in the relationships
between sponsors and CROs.
	
...
6
State of the
Industry and the
Role of the Avoca
Quality
Consortium
7
State of the Industry
●  Increase in clinical outsourcing
●  Consolidation of spend with fewer clinical service
provider...
8
Companies are “siloed” in their approaches. Industry interest in sharing, collaboration
and moving toward industry stand...
9
Vision: To accelerate the development of best
practice approaches and industry standards for
the proactive quality manag...
10
Avoca Research & Leading Practices
●  Avoca Research: Gathering of
quantitative and qualitative data
from Members; prov...
11
Avoca Quality Consortium Pharma/Biotech
Participation to Date
12
Avoca Quality Consortium CRO Participation to Date
13
Quality
Consortium
Leading Practices
14
Avoca Approach to Developing Leading
Practices
Tailor
Refine
Combine
Supplement
Member
Reviews
Edit
Adapt
Best
Practice...
15
Deliverables
AgreementQuality
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%
1...
17
Quality Agreement- Fundamental Elements
18
2012 Quality Agreement
Deliverable
2013 Quality Agreement
Modules
In 2013 We Delivered A New Modular Agreement
QA Templ...
19
Deliverables
MetricsQuality
20
to116
to 19
From 270
21
Making Sense of Consortium Metrics
!
!
!
!
!
!
!
!
!
!
!
!
!
Adequate!protec-on!of!subjects’!
rights!!
!
!
!
Adequate!p...
22
New Guidelines For
PROACTIVEQUALITY
MANAGEMENTand
EFFECTIVE OVERSIGHT
23
Eight Elements of Effective Oversight
Governance/Organizational Construct
Technical/Project Oversight
Process Oversight...
24
Define
Plan
Lead
Decide
Deliver
Measure
Eight Elements of Effective Oversight
Governance /
Organizational
Construct
Tec...
25
Quality Oversight Framework
Governance/
Organizational
Construct
Governance
Sourcing Models
Committee
Construct
Decisio...
26
Operationalizing Proactive Approaches to Quality
Management and Oversight
Process	
  Oversight	
  Guideline*	
  
•  Pro...
27
Governance/Organizational Construct
28
Online Library: Swim Lanes
29
Online Library: Decision Making Module Docs
3030
Overview for 2014
“Progress through Collaboration”
3131
●  Overview of 2014 Leading Practices – Focus
Areas:
1.  Quality Oversight Guidelines - Detailed Tools
and Templates
...
3232
2014 Leading Practice:
Pre-qualification Initiative
●  An initiative will be launched in 2014 focused on
sharing info...
3333
Develop Process and
Tools
•  Service-specific RFI
templates and scoring
tools
•  White paper case
studies: define ven...
3434
●  2014 Research of Consortium Members’ quality
management practices
●  2014 Benchmarking initiative focused on Study...
3535
●  The Avoca Quality Consortium will hold Member
forums and webinars designed to:
§  Promote collaboration and align...
3636
●  Participation for two attendees at the Annual Quality
Consortium Summit (May 6-7, 2014 in Princeton, NJ)
●  Partic...
3737
3838
THANK YOU!
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WebeX Presentation - Quality Consortium

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Overview of the Avoca Quality Consortium

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  1. 1. 1 Overview of Avoca Quality Consortium
  2. 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. 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. 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. 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. 6 State of the Industry and the Role of the Avoca Quality Consortium
  7. 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. 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. 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. 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. 11 Avoca Quality Consortium Pharma/Biotech Participation to Date
  12. 12. 12 Avoca Quality Consortium CRO Participation to Date
  13. 13. 13 Quality Consortium Leading Practices
  14. 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
  15. 15. 15 Deliverables AgreementQuality
  16. 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. 17 Quality Agreement- Fundamental Elements
  18. 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
  19. 19. 19 Deliverables MetricsQuality
  20. 20. 20 to116 to 19 From 270
  21. 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
  22. 22. 22 New Guidelines For PROACTIVEQUALITY MANAGEMENTand EFFECTIVE OVERSIGHT
  23. 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. 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. 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. 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  
  27. 27. 27 Governance/Organizational Construct
  28. 28. 28 Online Library: Swim Lanes
  29. 29. 29 Online Library: Decision Making Module Docs
  30. 30. 3030 Overview for 2014 “Progress through Collaboration”
  31. 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. 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. 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. 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. 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. 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
  37. 37. 3737
  38. 38. 3838 THANK YOU!
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