webex presentation - quality consortium
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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 ● Quality Consortium overview including approach
and deliverables to date ● Current focus areas
3
Client List
The Avoca Group Ph
arm
ac
eut
ica
l/Bi
ote
ch
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
Serv
ice
Pro
vid
ers
Acurian Marken
Aptiv Solutions MedAvante
Beardsworth Medical Research Consultants BioClinica
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
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
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
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 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
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
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
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
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 Practices
Concepts
Descriptions Details
What/How Tools
Select
Read Interpret
Assess Extract
Discuss
Review Documents
Presentations
Interviews Meetings
Collect
15
Deliverables
Agreement Quality
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
Com
pany
:
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
Quality Agreement- Fundamental Elements
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
Deliverables
Metrics Quality
20
to116 to 19 From 270
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!!ENSU
REING!QUALITY!
Outcom
es!(u
l-mate!“rep
ort!card”)!
Frac4on
!of!studies!achieving!passable!levels!
Process!q
uality!
(Doe
s!process,!whe
n!followed
,!lead!to!desired
!outcome?)!
Process!A
dheren
ce!!
(Is!process!be
ing!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
New Guidelines For
PROACTIVEQUALITY MANAGEMENT
and
EFFECTIVE OVERSIGHT
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
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
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
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
Governance/Organizational Construct
28
Online Library: Swim Lanes
29
Online Library: Decision Making Module Docs
30 30
Overview for 2014
“Progress through Collaboration”
31 31
● 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
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
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 One Phase 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
● 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
● 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
● 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
38 38
THANK YOU!
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