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
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
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
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
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
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
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
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
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. Thank you
Contact Avoca at:
(609) 252-9020
www.theavocagroup.com
info@theavocagroup.com
179 Nassau Street
Suite 3A
Princeton, NJ 08542
