WebeX Presentation - Quality Consortium

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1 Overview of Avoca Quality Consortium

description

Overview of the Avoca Quality Consortium

Transcript of WebeX Presentation - Quality Consortium

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Overview of Avoca Quality

Consortium

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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

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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

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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

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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.  

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State of the Industry and the

Role of the Avoca Quality

Consortium

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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

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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

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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

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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.

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Avoca Quality Consortium Pharma/Biotech Participation to Date

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Avoca Quality Consortium CRO Participation to Date

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Quality

Consortium Leading Practices

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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

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Deliverables

Agreement Quality

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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

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Quality Agreement- Fundamental Elements

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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

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Deliverables

Metrics Quality

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to116 to 19 From 270

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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

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New Guidelines For

PROACTIVEQUALITY MANAGEMENT

and

EFFECTIVE OVERSIGHT

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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

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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

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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  

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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  

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Governance/Organizational Construct

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Online Library: Swim Lanes

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Online Library: Decision Making Module Docs

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Overview for 2014

“Progress through Collaboration”

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● 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

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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

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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

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●  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

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●  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

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●  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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THANK YOU!