Avoca Investigative Site Survey Programs

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  • 1. Avocas Investigative SiteSurvey ProgramsService Offerings Overview

2. 2The Avoca GroupThe Avoca Group helps pharmaceutical and biotechcompanies and service providers build, measure, and manageWhy Avoca?critical business relationships. Avoca works exclusively in the pharmaceutical industry, focusing on clinicaloutsourcing, strategic alliances and alliance/relationship management. Avoca has a deep understanding of sponsor preferences, leading practicesand the health of relationships gained through nearly 15 years of collectingand analyzing quantitative and qualitative data on behalf of both sponsorsand CROs. Avocas Senior Consultants possess both process improvement and changemanagement expertise as well as significant industry experience. Avoca has unique perspectives of competing organizations practices andapproaches for alliance management. We understand areas thatcompetitors struggle with and can provide guidance to support effectivedifferentiation. 3. 3The Avoca GroupClient ListPharmaceutical/BiotechAstraZeneca GrnenthalBioMarin Johnson & JohnsonBoehringer-Ingelheim J&J PharmaceuticalBristol-Myers Squibb Research DevelopmentCadence MillenniumCeltic Pharma Nektar TherapeuticsCentocor Novo NordiskCerexa Ortho BiotechCJPCUS Ortho ClinicalCordis PfizerCR Bard Purdue PharmaCubist RegeneronEisai RocheEli Lilly Seattle GeneticsEndo Pharmaceuticals TerumoEthicon The MedicinesFerring Pharmaceuticals CompanyService ProvidersAcurian MarkenAptiv Solutions MedAvanteBeardsworth Medical ResearchBioClinica ConsultantsClinical FinancialServicesMetropolitanResearch AssociatesCRF Health PAREXELERT PPDExecuPharm PRA InternationalGreenphire Premier ResearchICONClinical ResearchQuest DiagnosticsClinical TrialsIdis QuintilesINC Research REGISTRAT-MAPIIndegene ResearchPointinVentivHealth ClinicalSynarcTheoremLabCorp TKL Research 4. 4Objective: Investigative Site Survey ProgramsGather feedback from Investigative Sites regarding their performanceand relationships with a pharmaceutical company and, whenrelevant, its clinical service providers.Capture actionable data that result in the ability to Support Site Relationship Management and build positive relationships withsites and coordinators. Evaluate the impact of outsourcing on investigative site relationships,including dependency on the specific provider used. Identify patterns of satisfaction by region, department, therapeutic area, orfunction, in order to isolate pockets of dissatisfaction that need to beaddressed, as well as pockets of high satisfaction that may be leveraged. Benchmark: With a number of variables, data can be benchmarkedagainst reference ranges in Avocas datasets. 5. 5Investigative Site Survey ProgramsApproach Specific information gathered as part of the program may include, but not belimited to, Investigators and other site staffs opinions regarding the following: The company and its clinical service providers expectations of study sites (e.g.,reasonableness) Effectiveness of communications with sites Support and training provided by sponsor (and/or CRO) Protocol design (e.g., complexity, clarity, soundness) Specific study practices and processes (e.g., data entry/management) or thestate of the overall relationship Quality of staff assigned to work with site Financial compensation Differences in perceptions across selected groups (e.g., regional, therapeutic,best sites vs. others, respondent role) are examined for underlying patterns. Based on Avocas experience, the response rate for this type of researchproject using a web survey could range from 10% to 20%. 6. 6Investigative Site Survey ProgramsApproach Reporting At the conclusion of the research, Avoca provides an aggregate reportwith appropriate sub-analyses. Depending on the sample size, Avoca determines if an analysis ofverbatim responses should be performed; Avoca provides an electronicWorkbook for reviewing actual verbatim responses if the sample is large. Avoca can develop an Executive Summary of the data specificallytailored for the investigative sites. Executive dashboards of results can be developed and tailoreddepending on clients needs. Reports are used as a catalyst for discussion at Strategy Meetings withoperational management.The Result: Clarity and direction regarding action items and next steps withresponding to feedback, both internally and with the sites 7. Sample Data 8. 8Investigator Feedback: Main CategoriesMain Assessment Categories by Region(Satisfaction rating scale of 5 to 1)Clinical trialconduct overall4. style overallOverall studyData capture andcleaning overallOverall protocol design managementAmericasAsiaEastern EuropeJapanWestern EuropeSampledataSub-analysis of the data may reveal patterns of importance. For example, this figure depicts the fact that Investigators frommost regions feel relatively favorably about the sponsors protocol design, and relatively unfavorably about its data capture andcleaning. However, there are significant regional differences in mean satisfaction levels in nearly every area. 9. 9Investigator Feedback: Working StyleWorking StyleN Mean787 4.4787 4.0783 3.8783 3.358%39%29%22%29%36%39%24%6%16%17%25%4%5%9%21%3%4%6%8%0% 20% 40% 60% 80% 100%Clear lines of communicationFosters team environmentSampledataResponsive to site issues/concernsRespect of the Investigators' time5 - Very Satisfied 4 3 2 1 - Very DissatisfiedIncluding appropriate, detailed survey questions for each major work area allows the results to be actionable. For example, this figuredepicts the responses to a few of the surveys detailed questions about the sponsors Work Style as it pertains to Investigator relationships. Ascan be seen, the Investigators as a group feel quite positively about the sponsors ability to keep lines of communication clear, but there is asignificant level of dissatisfaction when it comes to the sponsors respect of the Investigators time. 10. 10Investigator Feedback: Working StyleWorking Style: By Enrollment Volume1 to 5 5 to 20 21 to 50 >50266 325 115 61SampledataMaintains open communication 3.5 3.6 4.1 4.3Creates a team environment 3.5 4.0 3.9 4.4Responds to site concerns and issues 4.0 3.2 4.0 4.2Respect of the Investigators time 3.1 4.2 4.2 4.3Highest mean score for each variable is indicated in yellow; lowest in red.Scale of 5 to 1, with 5 being very satisfied and 1 being very dissatisfiedDrill-down analyses of the detailed survey questions permit the results to be even more actionable. For example, thistable depicts the fact that its primarily those Investigators who enrolled 5 or fewer subjects in the sponsors trials who feel thatthe sponsor is not respectful of their time investments. 11. 11Investigator Feedback: Clinical Trial ConductClinical Trial Conduct57%56%48%45%42%39%36%41%30%34%36%36%42%44%36%35%8%6%12%10%10%10%14%13%3%2%3%5%3%2%6%8%2%2%2%4%3%5%8%3%0% 20% 40% 60% 80% 100%Overall level of support during trial conduct andfollow-up, excluding patient recruitmentInvestigator GCP trainingTimeliness and accuracy of Investigator paymentsSupport for patient recruitment and retentionReliability of drug supplyClinical trial conduct overallProtocol-specific investigator trainingSetting of realistic patient recruitment goals/timelines5 - Very Satisfied 4 3 2 1 - Very DissatisfiedN Mean447 4.8413 4.5423 4.2427 4.2409 4.0410 4.0396 3.8352 3.5Sampledata 12. Thank youContact Avoca at:(609) 252-9020www.theavocagroup.cominfo@theavocagroup.com179 Nassau StreetSuite 3APrinceton, NJ 08542