Avoca’s Investigative Site 
Survey Programs 
Service Offerings Overview
2 
The Avoca Group 
The Avoca Group helps pharmaceutical and biotech 
companies and service providers build, measure, and ...
3 
The Avoca Group 
Client List 
Pharmaceutical/Biotech 
AstraZeneca Grünenthal 
BioMarin Johnson & Johnson 
Boehringer-In...
4 
Objective: Investigative Site Survey Programs 
Gather feedback from Investigative Sites regarding their performance 
an...
5 
Investigative Site Survey Programs 
Approach 
● Specific information gathered as part of the program may include, but n...
6 
Investigative Site Survey Programs 
Approach 
● Reporting 
╸ At the conclusion of the research, Avoca provides an aggre...
Sample Data
8 
Investigator Feedback: Main Categories 
Main Assessment Categories by Region 
(Satisfaction rating scale of 5 to 1) 
Cl...
9 
Investigator Feedback: Working Style 
Working Style 
N Mean 
787 4.4 
787 4.0 
783 3.8 
783 3.3 
58% 
39% 
29% 
22% 
29...
10 
Investigator Feedback: Working Style 
Working Style: By Enrollment Volume 
1 to 5 5 to 20 21 to 50 >50 
266 325 115 61...
11 
Investigator Feedback: Clinical Trial Conduct 
Clinical Trial Conduct 
57% 
56% 
48% 
45% 
42% 
39% 
36% 
41% 
30% 
34...
Thank you 
Contact Avoca at: 
(609) 252-9020 
www.theavocagroup.com 
info@theavocagroup.com 
179 Nassau Street 
Suite 3A 
...
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Avoca Investigative Site Survey Programs

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Avoca Investigative Site Survey Programs

  1. 1. Avoca’s Investigative Site Survey Programs Service Offerings Overview
  2. 2. 2 The Avoca Group The Avoca Group helps pharmaceutical and biotech companies and service providers build, measure, and manage Why Avoca? critical business relationships. ● Avoca works exclusively in the pharmaceutical industry, focusing on clinical outsourcing, strategic alliances and alliance/relationship management. ● Avoca has a deep understanding of sponsor preferences, leading practices and the health of relationships gained through nearly 15 years of collecting and analyzing quantitative and qualitative data on behalf of both sponsors and CROs. ● Avoca’s Senior Consultants possess both process improvement and change management expertise as well as significant industry experience. ● Avoca has unique perspectives of competing organizations’ practices and approaches for alliance management. We understand areas that competitors struggle with and can provide guidance to support effective differentiation.
  3. 3. 3 The Avoca Group Client List Pharmaceutical/Biotech AstraZeneca Grünenthal BioMarin Johnson & Johnson Boehringer-Ingelheim J&J Pharmaceutical Bristol-Myers Squibb Research Development Cadence Millennium Celtic Pharma Nektar Therapeutics Centocor Novo Nordisk Cerexa Ortho Biotech CJPCUS Ortho Clinical Cordis Pfizer CR Bard Purdue Pharma Cubist Regeneron Eisai Roche Eli Lilly Seattle Genetics Endo Pharmaceuticals Terumo Ethicon The Medicines Ferring Pharmaceuticals Company Service Providers Acurian Marken Aptiv Solutions MedAvante Beardsworth Medical Research BioClinica Consultants 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 Objective: Investigative Site Survey Programs Gather feedback from Investigative Sites regarding their performance and relationships with a pharmaceutical company and, when relevant, its clinical service providers. Capture actionable data that result in the ability to… ● Support Site Relationship Management and build positive relationships with sites 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, or function, in order to isolate pockets of dissatisfaction that need to be addressed, as well as pockets of high satisfaction that may be leveraged. ● Benchmark: With a number of variables, data can be benchmarked against reference ranges in Avoca’s datasets.
  5. 5. 5 Investigative Site Survey Programs Approach ● Specific information gathered as part of the program may include, but not be limited to, Investigators’ and other site staff’s 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 the state 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 Avoca’s experience, the response rate for this type of research project using a web survey could range from 10% to 20%.
  6. 6. 6 Investigative Site Survey Programs Approach ● Reporting ╸ At the conclusion of the research, Avoca provides an aggregate report with appropriate sub-analyses. ╸ Depending on the sample size, Avoca determines if an analysis of verbatim responses should be performed; Avoca provides an electronic Workbook for reviewing actual verbatim responses if the sample is large. ╸ Avoca can develop an Executive Summary of the data specifically tailored for the investigative sites. ╸ Executive dashboards of results can be developed and tailored depending on client’s needs. ╸ Reports are used as a catalyst for discussion at Strategy Meetings with operational management. The Result: Clarity and direction regarding action items and next steps with responding to feedback, both internally and with the sites
  7. 7. Sample Data
  8. 8. 8 Investigator Feedback: Main Categories Main Assessment Categories by Region (Satisfaction rating scale of 5 to 1) Clinical trial conduct overall 4.4 4.2 4.0 3.8 3.6 3.4 3.2 Work style overall Overall study Data capture and cleaning overall Overall protocol design management Americas Asia Eastern Europe Japan Western Europe Sample data Sub-analysis of the data may reveal patterns of importance. For example, this figure depicts the fact that Investigators from most regions feel relatively favorably about the sponsors’ protocol design, and relatively unfavorably about its data capture and cleaning. However, there are significant regional differences in mean satisfaction levels in nearly every area.
  9. 9. 9 Investigator Feedback: Working Style Working Style N Mean 787 4.4 787 4.0 783 3.8 783 3.3 58% 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 communication Fosters team environment Sample data Responsive to site issues/concerns Respect of the Investigators' time 5 - Very Satisfied 4 3 2 1 - Very Dissatisfied Including appropriate, detailed survey questions for each major work area allows the results to be actionable. For example, this figure depicts the responses to a few of the survey’s detailed questions about the sponsor’s Work Style as it pertains to Investigator relationships. As can be seen, the Investigators as a group feel quite positively about the sponsor’s ability to keep lines of communication clear, but there is a significant level of dissatisfaction when it comes to the sponsor’s respect of the Investigators’ time.
  10. 10. 10 Investigator Feedback: Working Style Working Style: By Enrollment Volume 1 to 5 5 to 20 21 to 50 >50 266 325 115 61 Sample data Maintains open communication 3.5 3.6 4.1 4.3 Creates a team environment 3.5 4.0 3.9 4.4 Responds to site concerns and issues 4.0 3.2 4.0 4.2 Respect of the Investigators’ time 3.1 4.2 4.2 4.3 Highest 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 dissatisfied Drill-down analyses of the detailed survey questions permit the results to be even more actionable. For example, this table depicts the fact that it’s primarily those Investigators who enrolled 5 or fewer subjects in the sponsor’s trials who feel that the sponsor is not respectful of their time investments.
  11. 11. 11 Investigator Feedback: Clinical Trial Conduct Clinical Trial Conduct 57% 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 and follow-up, excluding patient recruitment Investigator GCP training Timeliness and accuracy of Investigator payments Support for patient recruitment and retention Reliability of drug supply Clinical trial conduct overall Protocol-specific investigator training Setting of realistic patient recruitment goals/ timelines 5 - Very Satisfied 4 3 2 1 - Very Dissatisfied N Mean 447 4.8 413 4.5 423 4.2 427 4.2 409 4.0 410 4.0 396 3.8 352 3.5 Sample data
  12. 12. Thank you Contact Avoca at: (609) 252-9020 www.theavocagroup.com info@theavocagroup.com 179 Nassau Street Suite 3A Princeton, NJ 08542

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