SUMMIT 2013

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SUMMIT 2013

  1. 1. Avoca QualityConsortium SummitMay 9, 2013The Westin Princeton atForrestal VillagePrinceton, NJ
  2. 2. Welcome!
  3. 3. 3Avoca Quality Consortium SummitStephen Cutler, PhDGroup President, ICON Clinical Research
  4. 4. 4Supporting Sponsors
  5. 5. 5Summit Co-ChairsChristopher J. HiltonVice President, Development and ClinicalAlliance Management, Pfizer, Inc.Michael D. JonesSenior Director, Clinical Trial: Materials,Implementation and Transformation,Eli Lilly and Company
  6. 6. 6WelcomeJeffrey Kasher, PhD.Vice President, Clinical Trial:Materials, Implementation andTransformation, Eli Lilly andCompany
  7. 7. 7WelcomeAnn Meeker-O’ConnellActing Division Director, Good Clinical PracticeCompliance, US Food & Drug Administration
  8. 8. 8Summit ThemeAchieving the right balance between meetingtimelines, ensuring cost containment andachieving the highest level of quality
  9. 9. 9Our Anchor – Why We Are HereImproving human health and bringing life savingmedicines to patients
  10. 10. 10Summit Focus●More collaborative and effectivepartnerships●Greater efficiency●Mitigation of risk●Highest levels of quality
  11. 11. 11Summit TopicsGaining clarity in the areas of:• Proactive Quality Management• Effective oversight• Risk Assessment and RiskManagement• Change Management• Culture and Quality
  12. 12. 12Avoca Quality ConsortiumOur vision:● To serve as a catalyst for the acceleration of best practices forproactive quality managementConsortium Sponsors:The work of the Avoca Quality Consortium is inhelping members optimize their approaches to proactivequality management with an emphasis on bringingsponsors and CROsinto greater alignment.
  13. 13. 13Avoca Quality ConsortiumPharma/Biotech Industry Participation to Date
  14. 14. 14Avoca Quality ConsortiumCRO Participation
  15. 15. 15Avoca Quality ConsortiumOngoing Initiatives● Quality Agreement Template● Short list of Quality Metrics● Specific tools for Proactive Quality Management● Guidelines● Definitions● Setting Expectations tool● Research● Benchmarking of  each  company’s  Quality  Management  practices  ● Assessment of approaches to prequalification and routine audits● Comprehensive assessment of the way our Members are assessing andmanaging risk
  16. 16. 16Our Request for TodayPlease join thediscussion!
  17. 17. 17A Message from JeffJeffrey Kasher, PhD.Vice President, Clinical Trial:Materials, Implementation andTransformation, Eli Lilly andCompany
  18. 18. 18Our ModeratorsMarc MonseauFounder and Managing Partner,Mint Collective, LLCSteve WhittakerSenior Consultant and Director of the AvocaQuality Consortium, The Avoca Group
  19. 19. 19Today’s  Agenda  Breakfast sponsored byMorning Sessions:Introductory Remarks╸Michael Jones, Sr. Director, Clinical Trial: Materials, Implementationand Transformation, Eli Lilly & Co.╸Stephen Cutler, PhD, Group President, ICON Clinical Research╸Christopher J. Hilton, Vice President, Development and ClinicalAlliance Management, Pfizer, Inc.
  20. 20. 20Today’s  Agenda  Morning Sessions (continued):Strategies for Ensuring Effective Oversight╸Insights from Ann Meeker-O’Connell,  Acting  Division  Director,  Good  Clinical Practice Compliance, US FDA╸Data  from  Avoca’s  Consortium  Research╸Panel Discussion facilitated by Steve Whittaker
  21. 21. 21Today’s  Agenda  Morning Sessions (continued):Risk Assessment and Risk Management in Outsourced Clinical Trials╸Insights from Ann Meeker-O’Connell,  ╸Data  from  Avoca’s  Consortium  Research╸Panel Discussion facilitated by Steve Whittaker
  22. 22. 22Today’s  Agenda  Lunch (12:10 pm)sponsored by:Afternoon Sessions:Master Class in Leading ChangePeter Bregman, CEO, Bregman Partners╸Peter Bregman will lead an interactive working session on changemanagementCreating a Culture of Quality╸Components that Comprise a Culture of Quality: Margaret Davis,Margaret Davis Consulting╸Panel discussion moderated by Steve Whittaker
  23. 23. 23Today’s  Agenda  Afternoon Sessions (continued):Crowdsourcing Solutions╸Group brainstorming – generating ideas to enhance quality╸Facilitator: Marc MonseauCall to Action╸Panel discussion focused on implementing new strategies forproactive quality management╸Facilitators: Marc Monseau and Steve WhittakerConversation continues during a cocktail reception (5:15 pm)sponsored by
  24. 24. 24Avoca Quality Consortium SummitA message from John Hubbard, Worldwide Head ofDevelopment, Pfizer
  25. 25. 25Introductory RemarksStephen Cutler, PhDGroup President, ICON ClinicalResearchChristopher J. HiltonVice President, Development andClinical Alliance Management,Pfizer, Inc.Michael JonesSr. Director, Clinical Trial: Materials,Implementation and Transformation,Eli Lilly and Company
  26. 26. Effective Oversight
  27. 27. 27Effective OversightAnn Meeker-O’ConnellActing Division Director, Good Clinical PracticeCompliance, US Food & Drug Administration
  28. 28. Session 2: Strategies forEnsuring EffectiveOversightMay 9, 2013
  29. 29. 29Strategies for Ensuring Effective OversightOutline: Interim results from 2013Quality ConsortiumAssessment Approach for creatingguidelines for proactive qualitymanagement and effectiveoversight Executive panel discussion
  30. 30. 30Quality Consortium AssessmentSponsor: The operational teamsinvolved in overseeing our CROsconsistently micromanage to ensurethat the quality of deliverables meetsexpectations.CRO: The sponsors with which I workconsistently micromanage to ensurethat the quality of deliverables meetsexpectations.N=208 N=13421%31%33%11%4% 7%47%31%12%3%7%5%1%4%5%4%47%31%31%25%14%21%31%34%33%34%41%29%12%24%24%29%34%30%3%5%10%8%6%16%0% 20% 40% 60% 80% 100%The sponsors with which I work consistentlymicromanage to ensure that the quality ofdeliverables meets expectations.The sponsors with which I work clearly documentCRO oversight practices, roles, and responsibilities.The technology systems used by my company and itssponsor partners promote efficient oversightpractices.The sponsors with which I work clearly define theroles of internal and CRO staff so as to minimizeduplication of effort.The sponsors with which I work are efficient in theuse of resources applied to the oversight ofoutsourced trials.There is a direct positive relationship between theintensity of sponsor oversight and the quality of CROdeliverables.5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree
  31. 31. 31Strategies for Ensuring Effective OversightExecutive RoundtableCRO: There is a direct positiverelationship between the intensity ofsponsor oversight and the quality ofCRO deliverables.4%21%29%30%16%7%5%1%4%5%4%47%31%31%25%14%21%31%34%33%34%41%29%12%24%24%29%34%30%3%5%10%8%6%16%0% 20% 40% 60% 80% 100%The sponsors with which I work consistentlymicromanage to ensure that the quality ofdeliverables meets expectations.The sponsors with which I work clearly documentCRO oversight practices, roles, and responsibilities.The technology systems used by my company and itssponsor partners promote efficient oversightpractices.The sponsors with which I work clearly define theroles of internal and CRO staff so as to minimizeduplication of effort.The sponsors with which I work are efficient in theuse of resources applied to the oversight ofoutsourced trials.There is a direct positive relationship between theintensity of sponsor oversight and the quality of CROdeliverables.5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagreeN=135Sponsor: I personally have receivedhigh-quality deliverables from CROs,even when overseeing their work at a"strategic" rather than detailed level.6%35%34%17%8%N=193
  32. 32. 32Quality Consortium AssessmentSponsor: My companyclearly documents CRO oversightpractices, roles, and responsibilities.CRO: The sponsors with which I workclearly document CRO oversightpractices, roles, and responsibilities.N=208 N=13112%40%23%20%5% 5%31%34%25%5%7%5%1%4%5%4%47%31%31%25%14%21%31%34%33%34%41%29%12%24%24%29%34%30%3%5%10%8%6%16%0% 20% 40% 60% 80% 100%The sponsors with which I work consistentlymicromanage to ensure that the quality ofdeliverables meets expectations.The sponsors with which I work clearly documentCRO oversight practices, roles, and responsibilities.The technology systems used by my company and itssponsor partners promote efficient oversightpractices.The sponsors with which I work clearly define theroles of internal and CRO staff so as to minimizeduplication of effort.The sponsors with which I work are efficient in theuse of resources applied to the oversight ofoutsourced trials.There is a direct positive relationship between theintensity of sponsor oversight and the quality of CROdeliverables.5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree
  33. 33. 33Quality Consortium AssessmentSponsor: My companyclearly defines the roles of internaland CRO staff so asto minimize duplication of effort.CRO: The sponsors with which I workclearly define the roles of internaland CRO staff so asto minimize duplication of effort.N=209 N=1276%34%34%18%8% 4%25%34%29%8%7%5%1%4%5%4%47%31%31%25%14%21%31%34%33%34%41%29%12%24%24%29%34%30%3%5%10%8%6%16%0% 20% 40% 60% 80% 100%The sponsors with which I work consistentlymicromanage to ensure that the quality ofdeliverables meets expectations.The sponsors with which I work clearly documentCRO oversight practices, roles, and responsibilities.The technology systems used by my company and itssponsor partners promote efficient oversightpractices.The sponsors with which I work clearly define theroles of internal and CRO staff so as to minimizeduplication of effort.The sponsors with which I work are efficient in theuse of resources applied to the oversight ofoutsourced trials.There is a direct positive relationship between theintensity of sponsor oversight and the quality of CROdeliverables.5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree
  34. 34. 34Quality Consortium AssessmentSponsor: My companyis efficient in the use of resourcesapplied to the oversight ofoutsourced trials.CRO: The sponsors with which I workare efficient in the use of resourcesapplied to the oversight ofoutsourced trials.N=207 N=1285%28%29%32%6% 5%14%41%34%6%7%5%1%4%5%4%47%31%31%25%14%21%31%34%33%34%41%29%12%24%24%29%34%30%3%5%10%8%6%16%0% 20% 40% 60% 80% 100%The sponsors with which I work consistentlymicromanage to ensure that the quality ofdeliverables meets expectations.The sponsors with which I work clearly documentCRO oversight practices, roles, and responsibilities.The technology systems used by my company and itssponsor partners promote efficient oversightpractices.The sponsors with which I work clearly define theroles of internal and CRO staff so as to minimizeduplication of effort.The sponsors with which I work are efficient in theuse of resources applied to the oversight ofoutsourced trials.There is a direct positive relationship between theintensity of sponsor oversight and the quality of CROdeliverables.5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree
  35. 35. 35Quality Consortium AssessmentSponsor: The technology systemsused by my company and its CROpartners promote efficient oversightpractices.CRO: The technology systems used bymy company and its sponsor partnerspromote efficient oversight practices.N=204 N=1362%19%31%32%16%2%31%33%24%10%7%5%1%4%5%4%47%31%31%25%14%21%31%34%33%34%41%29%12%24%24%29%34%30%3%5%10%8%6%16%0% 20% 40% 60% 80% 100%The sponsors with which I work consistentlymicromanage to ensure that the quality ofdeliverables meets expectations.The sponsors with which I work clearly documentCRO oversight practices, roles, and responsibilities.The technology systems used by my company and itssponsor partners promote efficient oversightpractices.The sponsors with which I work clearly define theroles of internal and CRO staff so as to minimizeduplication of effort.The sponsors with which I work are efficient in theuse of resources applied to the oversight ofoutsourced trials.There is a direct positive relationship between theintensity of sponsor oversight and the quality of CROdeliverables.5 - Strongly agree 4 3 - Neither agree nor disagree 2 1 - Strongly disagree
  36. 36. Approach for CreatingGuidelines/Tools forEffective Oversight
  37. 37. 37Approach for Creating Guidelines/ToolsGovernanceOrganizationalConstructProcessesCommunicationOversightLeadershipMetrics /Analytics /TechnologyRoles /ResponsibilitiesOversightDefinePlanLeadDecideMeasureDeliverProactiveQualityManagement
  38. 38. ExecutiveRoundtable
  39. 39. 39Effective Oversight: Panel DiscussionMike CollinsVice President Global Clinical Operations, AlexionPharmaceuticalsStephen Cutler, Ph.D.Group President, ICON Clinical Research ServicesJames D. Eisenhart, Ph.D.CEO, Chiltern InternationalChristopher J. HiltonVice President, Development & Clinical AllianceManagement, Pfizer Development OperationsMichael D. JonesSenior Director, Clinical Trial: Materials,Implementation and Transformation, Eli Lilly andCompanyJeffrey McMullenVice Chairman, InVentiv Health, Inc.
  40. 40. Break
  41. 41. Risk Management andRisk Assessment
  42. 42. 42Risk Assessment and Risk ManagementAnn Meeker-O’ConnellActing Division Director, Good Clinical PracticeCompliance, US Food & Drug Administration
  43. 43. Risk Assessment andRisk Management inOutsourced ClinicalTrials
  44. 44. 44Risk Assessment and Risk ManagementDenise Calaprice-Whitty, Ph.D.Executive Director, Survey Research andRelationship Management Programs,The Avoca Group
  45. 45. Risk Assessment andRisk Management inOutsourced ClinicalTrials
  46. 46. 46OverviewTopics Explored● Risk-sharing models● Risk assessment: Is it formally done? How is it done? Are assessmentsjust qualitative, or also quantitative? Has it been successful? In whatways yes, and in what ways no?● Risk-based management approaches: To what tasks have suchapproaches been applied (e.g. monitoring, CRO management)? Have theapproaches used formal quantitative modeling, or have they beenqualitative? Have they been successful? Is the success realized mostly intime, cost, or quality? What have been the downsides?● Oversight
  47. 47. 47Interim Analysis● Sponsors:╸14 companieso 268 respondents● CROs:╸7 companieso 174 respondentsInterim Analysis
  48. 48. 48Use of Systematic Risk AssessmentN=165Sponsor Data50%23%13%13%1%N=119Approximately how often is a systematic risk assessment process employedfor clinical trials conducted by the teams with which you work?CRO Data35%19%19%14%13%For >75% of outsourcedclinical trialsFor 51% - 75% of outsourcedclinical trialsFor 25% - 50% of outsourcedclinical trialsFor 1% - 24% of outsourcedclinical trialsNever
  49. 49. 49Use of Systematic Risk AssessmentPlease briefly describe the conditions under which a systematicrisk assessment process is used:● Not many: very systematic and metrics based● Not consistent,  don’t  know;;  often  done  “in  silos”● Done,  but  not  necessarily  “systematic  and  rigorous”╸Too  high  level  and  “standard”  – copy and paste from previousstudies – no time to think about study-specific nuances
  50. 50. 50Use of Systematic Risk AssessmentPlease briefly describe the conditions under which a systematicrisk assessment process is used:● Only…╸During RFP process╸At governance level╸Ad hoc╸At program level, not study level╸For full-service CRO relationships╸For high-risk, complex, or large studies╸For audit strategy╸Upon sponsor request╸For key clients╸When resource limitations are a big concern
  51. 51. 5224%55%13%8%Generallyperformedprimarily by mycompanyGenerally a jointCRO-sponsorprocess, withapproximatelyequalcontributionsGenerallyconductedprimarily by theCROIt depends.N=134Sponsors: For outsourced clinical trials,to what extent is the CRO generallyinvolved in the systematic riskassessment?Involvement of CRO in Risk AssessmentCROs: To what extent are yourcompanys project team membersgenerally involved in the systematicrisk assessment?61%33%1%5%Generallyconductedprimarily by mycompanyGenerally a jointprovider-sponsorprocess, withapproximatelyequalcontributionsGenerallyperformedprimarily by thesponsorIt dependsN=128
  52. 52. 55Sponsors: In general, how satisfied are you with the performance of your in-house teams with respect to each of the following?8%8%6%7%12%4%7%7%48%43%38%39%25%34%25%26%31%35%35%33%41%45%44%42%12%10%19%13%17%11%19%20%2%4%3%8%5%5%4%5%0% 20% 40% 60% 80% 100%Proactive identification of potential risksAppropriateness of measures suggested or taken inreaction to risk-related informationProactive risk analysis and evaluationCommunications regarding risk-related trialinformationFrequency of review of risk-related trial informationOverall performance on risk assessment andmanagement related activitiesCompilation of risk-related trial information duringa trial (observations, trends, etc.)Rigor of review of risk-related trial information5 - Very satisfied 4 3 - Neither satisfied nor dissatisfied 2 1 - Very dissatisfiedN Mean170 3.5159 3.4162 3.3156 3.3151 3.2159 3.2161 3.1149 3.1Satisfaction with Risk Assessment: Sponsor Teams
  53. 53. 56Sponsors: In general, how satisfied are you with the performance of your CROpartners with respect to each of the following?3%2%3%4%1%1%2%1%23%20%17%17%16%16%14%15%45%40%41%31%38%39%34%29%20%25%28%31%35%31%32%38%9%13%11%15%10%13%19%17%0% 20% 40% 60% 80% 100%Appropriateness of measures suggested or taken inreaction to risk-related informationCommunications regarding risk-related trialinformationProactive identification of potential risksFrequency of review of risk-related trial informationOverall performance on risk assessment andmanagement related activitiesProactive risk analysis and evaluationRigor of review of risk-related trial informationCompilation of risk-related trial information duringa trial5 - Very satisfied 4 3 - Neither satisfied nor dissatisfied 2 1 - Very dissatisfiedN Mean148 2.9146 2.7157 2.7143 2.6147 2.6148 2.6139 2.5150 2.5Satisfaction with Risk Assessment: CRO Partners
  54. 54. 57Sponsors: In general, how satisfied are you with the performance of your otherservice providers with respect to each of the following?1%10%10%6%3%2%6%4%2%46%40%33%37%34%31%32%31%22%37%40%36%44%36%37%41%21%13%22%23%20%27%27%26%0% 20% 40% 60% 80% 100%Appropriateness of measures suggested or taken inreaction to risk-related informationProactive identification of potential risksOverall performance on risk assessment andmanagement related activitiesCommunications regarding risk-related trialinformationProactive risk analysis and evaluationFrequency of review of risk-related trial informationRigor of review of risk-related trial informationCompilation of risk-related trial information duringa trial (observations, trends, etc.)5 - Very satisfied 4 3 - Neither satisfied nor dissatisfied 2 1 - Very dissatisfiedN Mean87 2.598 2.586 2.286 2.291 2.283 2.281 2.185 2.1Satisfaction with Risk Assessment: Other ServiceProviders
  55. 55. 58CROs: In general, how satisfied are you with the performance of your companysteams with respect to each of the following?10%9%3%5%8%3%7%4%45%39%42%36%28%37%26%27%26%31%40%37%40%35%41%42%17%19%10%19%21%19%21%22%2%2%5%3%3%6%4%4%0% 20% 40% 60% 80% 100%Proactive identification of potential risksProactive risk analysis and evaluationAppropriateness of measures suggested or taken inreaction to risk-related informationOverall performance on risk assessment andmanagement related activitiesFrequency of review of risk-related trial informationCommunications regarding risk-related trialinformationCompilation of risk-related trial information duringa trial (observations, trends, etc.)Rigor of review of risk-related trial information5 - Very satisfied 4 3 - Neither satisfied nor dissatisfied 2 1 - Very dissatisfiedN Mean128 3.5126 3.3119 3.3123 3.2121 3.2123 3.1123 3.1121 3.0Satisfaction with Risk Assessment: In-house (CRO)Teams
  56. 56. 61Sponsors: In general, how difficult is it togain agreement between your company andyour clinical service provider (includingCRO) partners about the probability andimportance of the various risks associatedwith clinical trial conduct?21%46%29%4%EasySlightlydifficultSomewhatdifficultVery difficultDifficulty of Gaining Agreement re. RisksCROs: In general, how difficult is it to gainagreement between your company and yoursponsor partners about the probability andimportance of the various risks associatedwith clinical trial conduct?16%43%35%6%N=140 N=95
  57. 57. 64Benefits of Risk Assessment/Management:EfficiencyIn general, have your risk assessment and management approachesresulted in more efficient use of resources for your company and/or yourCRO partner?16%39%17%28%Sponsor Data CRO Data9%40%17%34%YesSometimesNoDont know/too soon to tellN=192 N=135
  58. 58. 66Benefits of Risk Assessment/Management: QualityIn general, have your risk assessment and management approachesresulted in increased quality?26%44%7%23%Sponsor Data CRO Data19%39%9%33%YesSometimesNoDont know/too soon to tellN=191 N=134
  59. 59. 69Understanding of Best Practices in RiskAssessment/ManagementHow would you rate your understanding of best practices in risk assessment andmanagement in clinical trials?8%53%32%7%Sponsor Data CRO Data8%40%41%11% Very strongunderstandingGoodunderstandingFairunderstandingPoorunderstandingN=195 N=134
  60. 60. 70Keys to Successful Risk Assessment/ManagementKeys to Successful Risk Assessment/Management● Vested interest in success╸Trust/transparency between partners╸Budgetary allowance/support from management╸Enforcement of/accountability for process and stipulatedactions● Education on risk assessment and resource allocation according torisk● Appropriate  “mature”  experience  (therapeutic  area,  operational,  development)  and  multifunction  team  to  “integrate”  risks● Well-defined roles and responsibilities in assessment and in theaction plan
  61. 61. 71Keys to Successful Risk Assessment/ManagementKeys to Successful Risk Assessment/Management● Right tools/technology/approach to define and monitor risks╸Initial assessment in parallel with protocol writing╸Examples of previous plans to trigger discussion – use ofLessons Learned╸Good metrics╸Beyond recruitment╸Qualitative and quantitative, with scoring● Update/review throughout a trial - recognized that risks are"dynamic" in that risks may change in probability or level of impact,and the responses, mitigations, or contingencies may need tochange as well.
  62. 62. 72Challenges of Successful RiskAssessment/ManagementChallenges in Successful Risk Assessment/Management● People see it as adding complexity – they know the risks anyway● Management or partner buy-in for proactive rather than reactive action(“extra  cost”)● Getting all stakeholders (departments, partners) to understand(appropriate background), prioritize, and participate● Timing – needs focus at study start, when other activities are also“burning”╸Not  part  of  the  “day  job”  but  a  “bolt  on”● Lack of basic understanding of concepts/process╸Poor facilitation that is list driven rather than analysis driven╸Difficult  to  identify  the  actual  risks  correctly,  focus  on  the  “wrong  risks”╸No visible in-house experts to rely on/mentor
  63. 63. 73Challenges of Successful RiskAssessment/ManagementChallenges in Successful Risk Assessment/Management● Poor tools╸“Box  checking”  risk  registers╸Poor (lagging) metrics● Lack of appropriate data to populate tools● Unclear accountability, for analysis and triggered actions (includingCRO vs. sponsor)● Inconsistency within sponsors in how this is handled– vendorsdon’t  know  what  to  expect● Process  “Completely  foreign”  to  vendors  beyond  CROs● Fear  of  “being  exposed”
  64. 64. 74How often do the project/program teams with which you work (including the CROpartners) use a risk-based approach to the monitoring of Investigative Sites foroutsourced clinical trials?Use of Risk-Based Monitoring19%15%12%21%22%11%Sponsor Data CRO Data17%19%12%9%16%27%For >75% of outsourcedclinical trialsFor 51% - 75% of outsourcedclinical trialsFor 25% - 50% of outsourcedclinical trialsFor 10% - 24% of outsourcedclinical trialsFor 1% - 9% of outsourcedclinical trialsNeverN=133 N=97
  65. 65. 75In general, have your risk-based monitoring approaches resulted in more efficientuse of resources for your company and/or your partner?Benefits of Risk-Based Monitoring: Efficiency19%19%13%49%Sponsor Data CRO Data13%22%6%59%YesSometimesNoDont know/too soon to tellN=165 N=113
  66. 66. 76In general, have your risk-based monitoring approaches resulted in increasedquality?Benefits of Risk-Based Monitoring: Quality17%25%7%51%Sponsor Data CRO Data14%16%10%60%YesSometimesNoDont know/too soon to tellN=163 N=112
  67. 67. 77Risk Assessment and Risk ManagementMerry ChuDirector, Medical Quality, Regional and ThirdParty Management, Eli Lilly Canada Inc.Heather JorajuriaGlobal Head, Product Development, QualityAssurance, F. Hoffmann-La Roche, Ltd. AndGenentech, Inc.Jeffrey A. KuefferSenior Vice President, Global OperationsManagement, INC Research®Margaret KeeganSenior Vice President & Global Head, IntegratedProcesses and Technologies, QuintilesAngelika Tillmann FRQAVice President Global Clinical Quality Assurance &Compliance, General Manager Europe, TheoremClinical Research
  68. 68. Sponsored byLunch
  69. 69. May Quality SummitThe Westin Princeton atForrestal VillagePrinceton, NJ
  70. 70. Masterclass: LeadingChange
  71. 71. 81Masterclass: Leading ChangePeter BregmanCEO, Bregman Partners
  72. 72. Creating a Culture ofQuality
  73. 73. 83Creating a Culture of Culture of QualityMargaret DavisPresident, Margaret Davis Consulting
  74. 74. Culture of QualityAvoca Consortium on QualityMay 9, 2013Meg DavisMargaret Davis Consulting
  75. 75. 85CultureThe collectively held beliefs and behaviorsof a group
  76. 76. 86Consistency:Coordination,Agreement,ValuesInvolvement:Empowerment,Team,SkillsMission:Vision, Strategy,GoalsAdaptability:Customer,Learning,ChangeBeliefsHigh Performing Culture
  77. 77. 87Hear others talk about qualityFeel quality all aroundSee others take quality-focused actionsTransfer quality to peersWhat is a Culture of Quality?
  78. 78. 88How common is Culture of Quality?Culture of Quality index scores - Quintiles
  79. 79. 89Does Culture of Quality affect performance?Culture’s  impact  on  mistakes  addressed  by  employeesWeekly, difference between top and bottom 20% in Culture of Quality index
  80. 80. 90What activities differentiate strongCultures of Quality from weak?
  81. 81. 91Key Differentiating ActivitiesEmployee Ownership● Understand quality fit with job● Comfortable raising quality concerns& challenging directives● Empowered to make decisions aboutqualityPeer Involvement● Have strong network of peers fordiscussion & guidance● Peers are involved in and heldaccountable for quality performanceMessage CredibilityMessages on quality and priorities are:● delivered by respected sources● easy to understand● appeal to me personallyLeadership Involvement● Leadership states that quality is apriority● Manager  emphasizes  quality’s  importance, and walks the talk onquality
  82. 82. 92EmployeeownershipPeerinvolvementLeadershipemphasisMessagecredibilityConsistency:Coordination,Agreement,ValuesInvolvement:Empowerment,Team,SkillsMission:Vision, Strategy,GoalsAdaptability:Customer,Learning,ChangeBeliefsCulture of Quality
  83. 83. 93Summary● Culture of Quality can be defined and measured● Culture of Quality affects performance● Culture of Quality can be driven by controllable activities
  84. 84. 94A Culture of Quality: Panel DiscussionPeter BregmanCEO, Bregman PartnersHazel CollieVice President, Head of Global CompoundDevelopment Quality & Systems, GrünenthalGmbHMargaret DavisPresident, Margaret Davis ConsultingJames R. DixonSenior Vice President, Global Quality andCompliance, PPDMitchell Katz, Ph.D.Executive Director, Medical ResearchOperations, Purdue Pharma L.P.
  85. 85. Let’s  Crowdsource:Generating Ideas toEnhance Quality
  86. 86. 96Approach3:00-3:05 – The Approach3:05-3:45 – Small Group Ideation (Led by group leaders)3:45-4:00 – Reporting and Capturing Insights
  87. 87. 97Challenge QuestionQualityAgreementGuidanceDocumentToolsTemplates/ModelsOnce these resources arecreated, how do youoperationalize them?
  88. 88. 98Challenge QuestionHow can we develop approaches to significantlyenhance the effective implementation ofdeliverables, initiatives and programs withindiverse organizations -- both sponsor companiesand CROs?Identify ONE approach, method or resource thatcan be developed to enable the implementation ofthese practical initiatives.
  89. 89. Call to Action
  90. 90. 100Call to Action: Panel DiscussionStephen Cutler, PhDGroup President, ICON Clinical ResearchChristopher J. HiltonVice President, Development & Clinical AllianceManagement, Pfizer Development OperationsMichael D. JonesSenior Director, Clinical Trial: Materials, Implementationand Transformation, Eli Lilly and CompanyHarris KofferPharm. D, President, Research Pharmaceutical Services,Inc.Jeffrey McMullenVice Chairman, InVentiv Health, Inc.John Potthoff, PhDPresident and CEO, Theorem Clinical Research
  91. 91. Call to Action
  92. 92. 102Upcoming EventsFall Meetings:• Consortium MembersMeeting• Executive Meeting
  93. 93. Thank you forjoining us!
  94. 94. May Quality SummitThe Westin Princeton atForrestal VillagePrinceton, NJ
  95. 95. Thank youContact Avoca at:(609) 252-9020www.theavocagroup.cominfo@theavocagroup.com179 Nassau StreetSuite 3APrinceton, NJ 08542

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