ISR’s report explores how often various outsourcing models are used, sponsor satisfaction with models, the driving forces behind using each type of model, as well as which situations would be likely to cause a sponsor to deviate from their standard outsourcing design.

1. EW
PR
EV
I
Sole
Source
InSourcing
Preferred
Provider
Compound
or
Program
Based
Functional
Service
Provider
Fee-forservice
Clinical Development
Outsourcing Models
Info@ISRreports.com
©2013 Industry Standard Research
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Report Overview
ISR’s report explores how often various outsourcing models are used, sponsor satisfaction with models, the
driving forces behind using each type of model, as well as which situations would be likely to cause a sponsor
to deviate from their standard outsourcing design.
Methodologies:
ISR conducted 100 quantitative surveys with 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
…and are knowledgeable about their company’s clinical development outsourcing model
74
Charts and Graphs
71
Q4, 2013
Pages
Publication Date
Report Structure:
1. Executive Summary
2. Clinical Development Outsourcing Dynamics
•
•
•
•
•
•
Distribution of outsourcing budget by activity
Drivers of outsourcing model selection
Current volume and anticipated growth/decline by outsourcing model
Preferred service provider type by phase of development
Outsourcing difficulties
Roles and responsibilities that influence service provider selection
3. Satisfaction, Selection, and Use of Outsourcing Models
• Analysis of each outsourcing model evaluated including the current and future anticipated volume of studies,
satisfaction with that model, and reasons to use that model
4. Future Predictions
• Likelihood to deviate from current model in specific scenarios
• Likelihood to change service providers based on trends
5. Study Data
Outsourcing Models Evaluated:
• Fee-for-service
• Preferred Provider
• Functional Service Provider
• In-Sourcing
• Compound or Program Based
• Sole Source
Learn how you can use this report.
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What you will learn in this report:
•
•
•
Benefits for each major outsourcing model
Percentage of outsourcing volume each model currently represents and how this will shift
by 2015
Sponsor satisfaction, reasons for selection, and details for how each model is used
How you can use this report:
•
For Study Sponsors: Identify which outsourcing models other organizations are utilizing,
their level of satisfaction, and their reasons for choosing that model.
•
For Service Providers: Define your marketing and operational strategy by understand your
customers’ current and future outsourcing needs and why they choose certain outsourcing
models.
Valuable for:
•
•
•
•
Outsourcing
Project Management
Clinical Operations
Clinical Service Providers
Up next: Full table of contents and sample pages
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Table of Contents
Full table of contents and additional sample pages available in the full preview,
free on our website:
http://www.isrreports.com/product/clinical-development-outsourcing-models/
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Sample Page: Report Introduction
Introduction
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Introduction
One way to think about the Russian clinical trial and pharmaceutical environment is
When it comes to outsourcing clinical development activities, there is a myriad
to think of that can be employed, traded from using only one provider for
of models the country as a publicallyrangingpharmaceutical company� If you were all
leafing through a prospectus or an vendor for each individual need. a comoutsourcing needs to selecting ainvestor presentation, you would find Certainly,
pany with strong macro fundamentals, historic
each sponsor organization must decide for growth, inconsistent(or set of models)
itself what model performance,
and some regulatory uncertainty� In short, Russia has many of the same characterbest suits mid-stage pharmaceutical company� And, if you take a portfolio theory
istics as a its clinical development needs.
approach to investing, you would likely want to invest some portion only one or
ISR has found that most companies do not limit themselves toof your assets two
in Russia� Why?
outsourcing models. The average sponsor in this survey uses four different
outsourcing models and will mix and match which model is to be used based
↑ Macroeconomics: Russia is the world’s 10th largest economy
on the need. Sponsors, however, may have different reasons for using the same
↑ International recognition: Joined the World Trade Organization (WTO) in 2012
model. One sponsor may choose to use preferred provider model to achieve
reduced costs while another might ~$240B trade model to achievefuel reserves
↑ Positive balance sheet: Russia has employ the surplus from fossil a deeper
relationship with each provider.
↑ Focus: Putin announced $3�9B plan aimed at having 90% of medicines to be
This locally produced by 2020 often various outsourcing models are used, sponsor
research explores how
satisfaction with models, theMedicines Insurance System (Aug 2012) is to be in
↑ Reimbursement structure: driving forces behind using each type of model, as
well place by 2020 that will include a tiered rate of reimbursement, depending on their
as which situations would be likely to cause a sponsor to deviate from
standard outsourcing design. improve access to medications
the nature of the illness, and
↑ Growth: Russian pharmaceutical market has been growing 17% annually since
2005
↑ Untapped potential: Many patients are treatment naïve, offering opportunities
for clinical trial patient recruitment
↓ Uncertainty: Regulatory environment and customs practices are unstable and
unpredictable
↓ Difficult: In 2012 the World Bank ranked Russia 122nd on their list of economies
by ease of doing business, 21 spots below China
↓ Skills: Finding highly qualified healthcare professionals can be difficult
↓ Protection: IP protection is concerning
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Sample Page
Executive Summary: Clinical Development Outsourcing Dynamics
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Preferred Service Provider Type by Phase
Respondents prefer to useuse small, niche CROs forPhase I trials; mid-size, fullRespondents prefer to small, niche CROs for their their Phase I trials.
service CROs for Phase II trials;pressures global CROs for their Phase III and Phase IV
Company policies or other and large, may not always permit respondents
trials. Company policies orof CRO but the may not always permit respondents to use
to use their first choice other pressures chart below shows the type of
their first choice of Provider Type by Phase use if the choice CROs that respondents
Preferred Service CRO but the chart below
CROs that respondents would prefer to shows the type of were completely
would prefer prefer toifuse small, niche CROs for their Phasetotrials; mid-size, fullRespondents
up to them.to use the choice were completely up I them.
service CROs for Phase II trials; and large, global CROs for their Phase III and Phase IV
trials. Company policies or other pressures may not always permit respondents to use
their choice were completely up below shows type of service providers would
“If thefirst choice of CRO but the chart to you, whatthe type of CROs that respondents you
would prefer to use if the choice were completely up to them.
choose to help your organization conduct clinical trials?” (Base = 100)
“If the choice were completely up to you, what type of service providers would you
choose to help your organization conduct clinical trials?” (Base = 100)
100%
1%
1%
6%
12%
90%
9%
3%
1%
18%
3%
6%
11%
% of Respondents
80%
70%
60%
49%
50%
32%
48%
Data available in full report
40%
78%
30%
23%
20%
10%
48%
36%
15%
0%
Phase I
Phase II
Staffing companies
Phase III
Phase IV
© Industry Standard Research
Specialty service providers (Bios, DM, Patient recruitment, Labs)
Small, niche CROs
Mid-size, full-service CROs
Large, global CROs
www.isrreports.com
© 2013|
S ponsor
U se
o f
C linical
D evelopment
O utsourcing
M odels10
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Sample Page
Full table of contents and additional sample pages available in the full preview,
free on our website:
http://www.isrreports.com/product/clinical-development-outsourcing-models/
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Ordering Information
For pricing and ordering information, visit our website:
http://www.isrreports.com/product/clinical-development-outsourcing-models/
About Industry Standard Research
Industry Standard Research (ISR) is the premier, full service market research provider to the pharma
and pharma services industries. With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise.
For more information about our off-the-shelf intelligence and custom research offerings, please visit
our Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports.
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9. The ISR Difference
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Custom-quality syndicated market research
www.ISRreports.com
ISR's Reports
vs.
The Common
Syndicated Report
How confident are you?
Research methods
Mostly primary
research;
always appropriate
for the topic
vs.
vs.
One size fits all;
usually publically
available data
Data Collection
ISR's proprietary data collection
tools and channels support fast,
high quality data collection
vs.
Struggle to recruit the right
targets and enough of them
Respondents
Sophisticated screening
ensures genuine
decision-makers
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Undisclosed
methodologies and
respondent demographics
Sample Sizes
Robust sample sizes that
instill confidence
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Often insufficient industry
representation that leaves you
defending results
Analysts
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means more insights that are
immediately usable
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reporting numbers
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