The document discusses services provided by The Avoca Group to help companies build, measure, manage, and improve critical business relationships, particularly strategic partnerships between biopharmaceutical sponsors and clinical research organizations (CROs). Avoca has extensive experience consulting on strategic partnerships in clinical outsourcing. They developed the Art and Science of Partnering framework to help manage these relationships. Services include partnership assessments through surveys, consulting on implementation and change management, and training on best practices for strategic partnerships.

1. Improving the Health
of Critical Business
Relationships
Creating a Standard for
Successful Strategic
Partnerships
Service Offering Review
March 2014

2. The Avoca Group
What We Do
The Avoca Group helps pharmaceutical and biotech companies,
CROs, and other service providers build, measure, manage, and
thereby improve critical business relationships.
● The Avoca Group has extensive experience in the area of strategic
partnerships and alliances between sponsors and CROs. Avoca combines
real world experience in clinical outsourcing, clinical research and the
management of relationships in this industry with leading practices in
change management to help companies successfully implement new
partnering strategies.
● Avoca draws upon its 15 years of gathering data in the area of sponsor-CRO
partnerships, utilizes this research as part of our consulting practice, and
incorporates industry data into Avoca training programs. Avoca developed
the Art and Science of Partnering™ framework, a best practice approach
for managing strategic relationships in the pharmaceutical industry.
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3. The Avoca Group
Client List
AstraZeneca
Boehringer-Ingelheim
Cadence
Novo Nordisk
Cerexa
Ortho Biotech
CJPCUS
Ortho Clinical
Cordis
Pfizer
CR Bard
Purdue Pharma
Cubist
Regeneron
Eisai
Roche
Endo Pharmaceuticals
Terumo
Cardinal Health
Millennium
Centocor
Ethicon
Ferring Pharmaceuticals
The Medicines
Company
Medical Research
Consultants
BioClinica
Service Providers
Celtic Pharma
MedAvante
Beardsworth
J&J Pharmaceutical
Research Development
Marken
Aptiv Solutions
Johnson & Johnson
Bristol-Myers Squibb
Pharmaceutical/Biotech
Acurian
Grünenthal
Clinical Financial
Services
Metropolitan
Research Associates
PAREXEL
CRF Health
PPD
ERT
PRA International
ExecuPharm
Premier Research
Greenphire
Quest Diagnostics
Clinical Trials
ICON
Clinical Research
Quintiles
Idis
REGISTRAT-MAPI
INC Research
ResearchPoint
Indegene
Synarc
inVentiv Health Clinical
Theorem
LabCorp
TKL Research
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4. Measuring the Health of Strategic Partnerships
The Reality of Strategic Partnerships: 2012 Industry Survey Results
In 2012, Avoca conducted its annual industry survey with a focus on the reality
of Strategic Partnerships. Among the key findings were the following:
● Forty-seven percent of the sponsor companies surveyed had strategic
partnerships with clinical service providers (currently, or in the past), and 67% of
the service provider companies surveyed reported having strategic partnerships
with sponsors.
● Twenty-two percent of sponsor companies reported having discontinued strategic
relationships. Most commonly, these relationships were discontinued by sponsors
because of poor quality of deliverables, followed by poor overall performance of
the clinical service provider.
● Among sponsors, overall satisfaction with the work performed by strategic
partners appeared to increase with the duration of the partnership; 86% of
respondents reporting on strategic partnerships of three or more years were
satisfied, compared to 67% of respondents evaluating strategic partnerships of
less than three years in duration.
Avoca brings these research capabilities and perspectives to all of our
consulting engagements.
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5. Measuring the Health of Strategic Partnerships
Critical Success Factors
Avoca believes the following components are necessary for successful
implementation of a new standard for alliance management:
● Clear vision and goals for the establishment and management of alliances
● A comprehensive framework for the model, including a tailored approach for the
governance and management of the strategic relationships
● Input from and engagement with key stakeholders
╸ It is Avoca’s philosophy that successful change comes only when stakeholders are
supported in their interests to contribute to the change.
● Clarity and consistency in internal communications regarding the new alliance
management model
● Documented, comprehensive, and standard approaches: establishing alliances,
managing alliances, and ongoing measurement of alliances
╸ Should include a system for gathering Lessons Learned information and
disseminating that information for the benefit of future projects with the same
alliance partner and/or for ensuring the success of projects with future partners
● Alignment with and incorporation of other corporate initiatives and standards
● Senior level support
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6. Measuring the Health of Strategic Partnerships
Three Main Areas of Support
● Avoca Survey Research
╸ Partnership Health Assessment: Gathering of actionable data to drive
strategy implementation
╸ Ongoing Feedback Programs to assess success during project
execution
╸ Annual assessment to continue to monitor “pulse” of the partnership
● Avoca Consulting: Strategy Implementation and Change Management
╸ Assistance with engaging key stakeholders, including senior staff and
clinical operations, from sponsor and partners to ensure acceptance
and support of the outsourcing model
╸ Facilitation of “lessons learned” meetings or alliance partnership
meetings
● Customized Training and Workshops
╸ Implementation of Avoca’s Art and Science of Partnering™ - Best
practices in Managing Strategic Partnerships
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7. Survey Research

8. Measuring the Health of Strategic Partnerships
Objectives of a Partnership Assessment
● To gather quantitative and qualitative baseline data for alliance managers
and senior staff from partner organizations to drive implementation of the
desired outsourcing strategy
● To understand perceptions about the outsourcing model so that issues can
be addressed proactively
● To identify needs for support from both sides of the partnership, including the
potential need for tools and training on managing relationships in a strategic
framework
● To engage staff from both partners throughout the process as part of
strategy implementation
Improved Relationships = Improved Performance
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9. Measuring the Health of Strategic Partnerships
Creation of Survey Instruments
● Avoca works collaboratively to develop customized survey instruments for
each partner
● The instrument collects a variety of information, including:
╸ Perceived opportunities and challenges associated with the current
outsourcing model
╸ Overall perceptions about working with CRO/Sponsor partners in the
existing or emerging outsourcing model
╸ Key Relationship Indicators (KRIs) to measure variables such as trust,
innovation, proactivity, communication, etc.
╸ The components, tools and resources required by teams to effectively
work together within the existing or emerging outsourcing model
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10. Measuring the Health of Strategic Partnerships
Approach
● Avoca develops a customized approach for the program during a kick-off
meeting.
● Surveys are either administered via the web, conducted by experienced,
industry-savvy Avoca telephone interviewers, or a hybrid approach is used.
● Names are not associated with results to encourage open and honest
feedback from all parties.
● Findings and conclusions are delivered in customized reports with
appropriate sub-analyses and reviewed with each partner company.
Avoca utilizes a consultative approach to make recommendations based
on our significant experience conducting partnership assessments and
consulting to facilitate optimal strategic partnerships.
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11. Sample Data

12. SAMPLE DATA
CRO Perspective: Transition to Strategic Partnering
Transition to Strategic Partnering
5 = Strongly Agree, 1 = Strongly Disagree
I will be comfortable accepting new responsibilities as
part of moving to Sponsor’s new outsourcing model.
38%
I am confident in my ability to successfully execute
my new responsibilities under Sponsor’s new
outsourcing model.
I have confidence that CRO will exercise effective
team leadership under the new strategic model.
29%
I am confident that CRO’s senior management will
support the new approach effectively.
Strongly
Agree
38%
Generally
Agree
44
11% 10%
4.1
44
11% 10%
36%
50%
29%
4.1
4.0
44
10%
3.9
45
7% 10%
3.7
46
10% 5%
50%
21%
N
48%
42%
I have confidence that CRO will be successful at
meeting Sponsor’s expectations for deliverables under
the new strategic model.
Mean
Neither Agree
Nor Disagree
19%
17%
Generally
Disagree
Strongly
Disagree
12

13. SAMPLE DATA
Sponsor vs. CRO Perceptions of Strategic Partnering
Sponsors
CROs
Do you feel that you fully understand the differences
between managing a strategic partner under the new
Strategic Partnering model and managing other
outsourcing relationships (e.g. tactical outsourcing)?
Do you feel that you fully understand how working in a
strategic relationship such as that with [Sponsor X] differs
from working in a more traditional (transactional) SponsorCRO relationship?
Don't Know
9%
N=125
No
44%
Don't Know
23%
Yes
47%
N=112
No
17%
Yes
60%
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14. SAMPLE DATA
Sponsor: Differences between Strategic Partnering and Other Models
Do you feel that you fully understand how working in a strategic relationship
differs from working in a more traditional (transactional) Sponsor-CRO
relationship?
N
Statistics
75%
Project Management
25%
71%
Clinical Operations
50%
Country Offices
14%
50%
Data Management
21%
35
29%
60%
20%
Yes
14%
42
50%
20%
0%
24
40%
No
40
35
20%
60%
80%
100%
Don't know
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15. SAMPLE DATA
Sponsor vs. CRO: Transition to Strategic Partnering
Sponsor vs. CRO: Transition to Strategic Partnering (mean ratings)
Sponsor
CRO
Difference
N=
145
166
I have confidence in CRO's ability to make appropriate operational
decisions [without input from Sponsor] under the new strategic model.
3.1
4.2
1.1
Within Sponsor, roles and responsibilities for the management of CROs
under Strategic Partnering are/appear to be clearly defined.
2.4
3.4
1.0
I have confidence that CRO will exercise effective team leadership under
the new strategic model.
3.2
4.2
1.0
I have confidence that CRO will be successful at meeting Sponsor’s
expectations for deliverables under the new strategic model.
3.3
4.3
1.0
For my areas of responsibility, I understand how CRO’s expectations of
Sponsor will change under the new model.
3.0
3.8
0.8
I believe that we will need to improve the way we work with CROs in order
to ensure success with the new outsourcing approach/I believe that
Sponsor will need to change the way that it works with clinical service
providers in order to ensure success with the new outsourcing approach.
3.2
3.9
0.7
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16. SAMPLE DATA
Sponsor & CRO Verbatim Comments
•
“I feel that both my company and our preferred CROs are doing a good job of
building towards the vision. We need to remember to step back and dedicate the
resources to ensuring the relationships are heading in the right direction, which is
difficult to do when we're all heads down getting drug development projects done.”
•
“ This sponsor insists my company's team’s handle communication with the sites in the
manner they see fit rather than allowing local teams to utilize their knowledge and
experience to decide how best to communicate with their sites. This style of
micromanagement has negatively affected site/Investigator relationships and also
limited the operational team's ability to perform at their highest level of capability.”
•
“It is much more difficult to meet the standards when all data is considered critical. I’d
like to see the team be more proactive in managing projects, to anticipate risks,
come up with contingency plans, and make recommendations based on our
experience.”
•
“We need more clearly defined expectations at study level and JOC/management
level. Teams are not organized and make changes during build process, causing
delays that impact build time metrics.”
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17. Art & Science of
Partnering™
Avoca Training

18. The Art and Science of Partnering™
The Avoca Model for Establishing Best Practices for
Working Effectively in Strategic Partnerships
Analysis
Action
A
Approach
Assessment
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19. The Art and Science of Partnering™
Analysis
Approach
Assessment
Action
• Preparing for launch: defining needs
and expectations based on Alliance
charter
• Creating a successful partnership:
establishing a shared operating model
• Managing and monitoring success
• Taking corrective measures and
positive action to ensure project/
partnership success
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20. The Art and Science of Partnering™
Avoca s methodology and instruction focuses on the two parallel
dimensions of Communication and Critical Thinking Skills
Analysis
Approach
Assessment
Action
g
Critical Thinkin
n
Communicatio
20

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