Avoca’s Investigative Site Survey Programs

Service Offerings Overview

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The Avoca Group

●  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.

Why Avoca?

The Avoca Group helps pharmaceutical and biotech companies and service providers build, measure, and manage

critical business relationships.

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The Avoca Group

Client List

Pha

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Bio

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AstraZeneca Grünenthal

BioMarin Johnson & Johnson

Boehringer-Ingelheim J&J Pharmaceutical Research Development Bristol-Myers Squibb

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 Company Ferring Pharmaceuticals

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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Objective: Investigative Site Survey Programs

●  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.

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…

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●  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%.

Investigative Site Survey Programs

Approach

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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

Sample Data

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Main Assessment Categories by Region (Satisfaction rating scale of 5 to 1)

3.2

3.4

3.6

3.8

4.0

4.2

4.4

Clinical trial conduct overall

Work style overall

Overall study management Overall protocol design

Data capture and cleaning overall

Americas

Asia

Eastern Europe

Japan

Western Europe

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.

Investigator Feedback: Main Categories

Sample data

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Investigator Feedback: Working Style

Working Style N Mean

787 4.4

787 4.0

783 3.8

783 3.3

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.

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

Responsive to site issues/concerns

Respect of the Investigators' time

5 - Very Satisfied 4 3 2 1 - Very Dissatisfied

Sample data

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1 to 5 5 to 20 21 to 50 >50

266 325 115 61

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

Working Style: By Enrollment Volume

Investigator Feedback: Working Style

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.

Sample data

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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

Thank you

Contact Avoca at: (609) 252-9020

www.theavocagroup.com

info@theavocagroup.com

179 Nassau Street Suite 3A

Princeton, NJ 08542