Most pharma companies no longer outsource simply because they have to. Most now recognize value in the use of contract organizations. But while the evolution of pharma’s outsourcing philosophy has been fairly uniform across companies, the application of outsourcing strategy remains highly diverse. The real trick for a head of R&D is identifying which model is best given the particular pharma company’s culture, infrastructure for clinical trial management, infrastructure for CRO management, depth of pipeline, and a host of other factors.

1. outsourcing
models
Clinical Development
Outsourcing Models
(2nd edition)
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©2015 Industry Standard Research www.ISRreports.com
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Report Overview
Most pharma companies no longer outsource simply because they have to. Most now recognize value in
the use of contract organizations. But while the evolution of pharma’s outsourcing philosophy has been
fairly uniform across companies, the application of outsourcing strategy remains highly diverse. The real
trick for a head of R&D is identifying which model is best given the particular pharma company’s culture,
infrastructure for clinical trial management, infrastructure for CRO management, depth of pipeline, and a
host of other factors.
Outsourcing Models Evaluated:
• Preferred Provider Outsourcing
• In-Sourcing Clinical Development Staff
• Fee-For-Service Outsourcing
• Functional Service Provider (FSP) Outsourcing
• Compound or Program-Based Outsourcing
• Hybrid Full Service and FSP Outsourcing
• Sole-Source Outsourcing
Q3,2015Publication Date
82Pages
89Charts and Graphs
Learn how you can use this report.
Methodology:
ISR surveyed 107 respondents who:
• Currently work at a pharma or biotech company with annual R&D expenditure of at least $100M
• Have responsibility for outsourcing clinical trials
• Are somewhat to highly knowledgeable about their company’s clinical development outsourcing model
Report Structure:
Executive Summary
Clinical Development Outsourcing Dynamics
• Outsourcing Cost Breakdown by Function
• Outsourcing Difficulties
• In-House and Outsourcing Model Allocation
• Preferred Service Provider Type by Phase
• Roles and Responsibilities that Influence Service Provider Selection
Outsourcing Models: Performance, Selection, and Use
• Analysis of each outsourcing model evaluated including model performance and reasons for use
Future Trends
• Likelihood to Deviate from Current Model
• Likelihood to Change Service Providers Based on Trends
Study Data

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NEXT: Table of contents and sample pages
What you will learn in this report:
• Benefits for each major outsourcing model
• Percentage of outsourcing volume each model currently represents and predictions for
future trends
• Sponsor satisfaction, reasons for selection, and details for how each model is used
How you can use this report:
• For Study Sponsors: Pharma buyers of this report are encouraged to use its content to
navigate the benefits and drawbacks of available outsourcing models by examining what’s
working and not working for other companies and why.
• For Service Providers: Service providers are encouraged to use the report’s content to plan
for the rise of some models, the decline of others, identify the drivers of success for these
models, and anticipate customers’ need accordingly.
Valuable for:
• Outsourcing
• RD Strategy
• Project Management
• Clinical Operations
• Clinical Service Providers

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Table of Contents
Full Table of Contents and additional sample pages are available on
ISR’s website: www.isrreports.com/?p=6088

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Executive Summary
www.ISRreports.com ©2015 | Clinical Development Outsourcing Models 7
given the particular pharma company’s
culture, infrastructure for clinical trial
management, infrastructure for CRO
management, depth of pipeline, and a
host of other factors�
Pharma buyers of this report are
encouraged to use its content to navigate
the benefits and drawbacks of available
outsourcing models by examining what’s
working and not working for other
companies and why�
Service providers are encouraged to use
the report’s content to plan for the rise of
some models, the decline of others, identify
the drivers of success for these models, and
anticipate customers’ need accordingly�
Introduction
Outsourcing in the pharmaceutical
industry is no longer in its infancy� The
past 25 years have witnessed an evolution
in pharma RD management strategy�
Outsourcing penetration for development
activities now stands at 60%� Most
pharma companies no longer outsource
simply because they have to� Most now
recognize value in the use of contract
organizations� Sure, many individuals
still hold strong preferences for using
in-house resources to run clinical trials,
but these attitudes tend to reside deep
within operational functions; much less
within executive management where
RD strategies are formed� Additionally,
where outsourcing once was limited to the
buying of “hands and feet” – supplemental
resources – organizations now regularly
purchase experience and guidance (they
still don’t like the word “strategy”)�
But while the evolution of pharma’s
outsourcing philosophy has been
fairly uniform across companies, the
application of outsourcing strategy
remains highly diverse� Many approaches
to the use of CROs remain in play for
those responsible for RD strategy� The
most common among them include:
preferred provider agreements, one-off
fee-for-service agreements, functional
service provider agreements, large scale
single-source partnerships, and a few
others of merit�
ISR’s data in the current report show
– in our judgment – acceptable levels
of satisfaction for most outsourcing
models� The real trick for a head of
RD is not identifying which model is
best, but rather, which model is best
MORE ENGAGEMENT
LESS ENGAGEMENT
In-house Resources
In-sourced Resources
One-off Fee-for-Service
One-off Program Outsourcing
Preferred Provider Agreement
Hybrid Full Service FSP
Functional Service Provider
Outsourcing
Sole-source Partnerships
Clinical Trial Outsourcing Models
Sample Page

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Outsourcing Models: Performance, Selection, and Use
www.ISRreports.com ©2015 | Clinical Development Outsourcing Models 21
Fee-For-Service Outsourcing
The top driver to use Fee-for-Service outsourcing is to access capabilities or expertise that
aren’t present within the sponsor organization� (Base = 54)
1) For local “small” studies, more flexibility
and less expensive compared to major
CROs. 2) Possibility to challenge
the CROs explaining that all studies are not
necessarily given to the preferred providers
(other criteria are influencing the decision).”
-Clinical Ops Manager, Non-large Pharma
To support niche indications
for which insufficient
information is available in-
house or at preferred vendors.”
-Clinical Ops Director, Large Pharma
Model Performance
Model Use
Top Reasons to Use Preferred Provider
(open-end)
Top Reasons to Use Preferred Provider
(respondents selected multiple)
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Clinical
Development
Outsourcing
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nd
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22
Fee-For-Service Outsourcing
The top driver to use Fee-for-Service outsourcing is to access capabilities or expertise
that aren’t present within the sponsor organization. (Base = 54)
9% 67% 22% 2%
0% 20% 40% 60% 80% 100%
Model Performance
% of Respondents
Greatly exceeds my expectations Somewhat exceeds my expectations
Meets my expectations Somewhat misses my expectations
Greatly misses my expectations
Top Reasons to Use Fee-For-Service (open-end)
Specific/niche capabilities (33%)
Preferred vendor unavailable/not viable (17%)
Flexibility (17%)
Best fit provider (11%)
Cost effectiveness (11%)
Top Drivers to Use Fee-For-Service (respondents selected multiple)
Access to specific skills/expertise not present within your organization
(76%)
Access to technology not present within your organization (46%)
More efficient clinical development activities (39%)
Increased resource flexibility (39%)
To support niche indications for
which insufficient information is
available in-house or at preferred
vendors.
-Clinical Ops Director, Large Pharma
1) For local small studies, more flexibility
and less expensive compared to major
CROs. / 2) Possibility to challenge the
CROs explaining that all studies are not
necessarily given to the preferred providers
(other criteria are influencing the decision).
-Clinical Ops Manager, Mid-size Pharma
• Specific/niche capabilities (33%)
• Preferred vendor unavailable/not viable (17%)
• Flexibility (17%)
• Best fit provider (11%)
• Cost effectiveness (11%)
• Access to specific skills/expertise not present within
your organization (76%)
• Access to technology not present within your
organization (46%)
• More efficient clinical development activities (39%)
• Increased resource flexibility (39%)
Preferred Provider Use by Company Size (Base=76)
Company Size % Model Use
Large 46%
Not Large 59%
© Industry Standard Research
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Clinical
Development
Outsourcing
Models
(2
nd
edition)
16
Preferred Provider Outsourcing
Cost reductions, improved relationships, and efficiencies are the main drivers for
sponsors to use the Preferred Provider model. (Base = 76)
18% 59% 17% 5%
0% 20% 40% 60% 80% 100%
Model Performance
% of Respondents
Greatly exceeds my expectations Somewhat exceeds my expectations
Meets my expectations Somewhat misses expectations
Greatly misses expectations
Top Reasons to Use Preferred Provider (open-end)
Preferred pricing / cost effective (46%)
Better vendor relationships (26%)
Efficiency (20%)
Easiest outsourcing method to manage (13%)
Better quality work/project manager (12%)
Top Drivers to Use Preferred Provider (respondents selected multiple)
Reduction in clinical development costs (63%)
Vendor consolidation, minimizing the number of vendor relationships
to maintain (59%)
Improved service provider relationships / deeper partnerships (55%)
Fully negotiated prices for all services,
streamlined processes, CRO team
members familiar with sponsor's
processes and requirements.
-Clinical Ops Director, Large
Pharma
Develop competencies, stringer
relationships, more affordable,
potential for better quality.
-Clinical Ops Director, Large Biotech
Sample Page
Sample Model Profile
The top driver to use this model of outsourcing is to access capabilities or expertise
that aren’t present within the sponsor organization. (Base = 54)

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Clinical Development Outsourcing Dynamics
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Outsourcing Difficulties
Nearly one-third of respondents mention that Finding a CRO with strong expertise/
capabilities is the most difficult part of outsourcing clinical development activities�
Managing timelines, Maintaining quality, and Selecting the best CRO for the project are
also difficult� These pain points are similar to the issues experienced by respondents in
2013 and seem to be ongoing struggles in the outsourcing world�
“In your opinion, what is the most difficult part of outsourcing clinical development
activities?” (Base = 107) (open-end)
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Clinical
Development
Outsourcing
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nd
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9
Outsourcing Difficulties
Nearly one-third of respondents mention that Finding a CRO with strong
expertise/capabilities is the most difficult part of outsourcing clinical development
activities. Managing timelines, Maintaining quality, and Selecting the best CRO for the
project are also difficult. These pain points are similar to the issues experienced by
respondents in 2013 and seem to be ongoing struggles in the outsourcing world.
“In your opinion, what is the most difficult part of outsourcing clinical development
activities?” (Base = 107) (open-end)
1%
2%
3%
3%
6%
9%
11%
12%
13%
16%
19%
19%
23%
31%
0% 10% 20% 30% 40%
Contracting / RFP
Recruitment
Maintaining control
Vendor management
Finding CRO with needed
reach
Establishing protocols for
study
Communication between
parties
Finding a CRO with good
project management teams
Establishing relationship /
partnership with CRO
Keeping cost down /
maintaining budget
Selecting best CRO for the
project
Maintaining quality
Managing timelines
Finding CRO with strong
expertise / capabilities
% of Respondents
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Sample Page

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Sample Page
Full Table of Contents and additional sample pages are available on
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