ISR’s report surveyed 119 respondents with responsibility and decision-making for Phase I study conduct and outsourcing activities. This report provides novel, first-hand insight into phase-specific study trends and the use of service providers for Phase I studies.

1. +COUNTRIES
2016
+SITES
+COMPLEX
2013
+PATients
2013 Phase I Study
Trends and Market
Outlook
Info@ISRreports.com
©2013 Industry Standard Research www.ISRreports.com
PREVIEW

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Report Overview
ISR’s report surveyed 119 respondents with responsibility and decision-making for Phase I study conduct and
outsourcing activities. This report provides novel, first-hand insight into phase-specific study trends and the use
of service providers for Phase I studies.
72
pages
119
respondents
73
charts and graphs
Major Sections:
What you will learn in this report:
• How study complexity, the use of patient populations, using multiple sites, and geographic locations
will impact sponsor activities and CRO needs
• Current and expected volume of Phase I trials for various sponsor segments
• Outsourcing market dynamics, including expectations for study distribution among types of service
providers, dollar value of outsourced studies, and sponsors’ in-house Phase I capabilities
• Sponsor preferences for 22 different Phase I service providers and the attributes seen as most
important when selecting a Phase I provider
Actionable Insights:
For Sponsors:
• Determine to what degree access to patient populations, alternative geographies, and multi-site and
multi-country studies should figure into your strategic planning
• Benchmark internal policies to select service providers and identify which of 22 service providers may
be the best fit your organizational needs
For Service Providers:
• Plan for sponsors’ anticipated increase/decrease in study volume, identify needs for anticipated future
study complexity, and for their upcoming Phase I studies
• Understand the competitive environment and how to best position your service offerings
Valuable for:
Clinical Operations, Research & Development, Medical Directors, Project Managers, and Service Providers
1. An Analysis of Phase I Market Dynamics
Study Volume: This section explores the current and expected volume of Phase I trials for various segments
of sponsors. We also delve into how the composition of these trials is expected to change moving forward in
terms of study complexity, use of patient populations, and use of multiple sites and geographic locations.
Outsourcing: In this section, ISR details the outsourcing market, including expectations for the proportions of
studies to be outsourced, dollar value of outsourced studies, and in-house Phase I capabilities. Additionally,
we examine how the outsourced work is split between various types of service providers as well as the unique
benefits of large CROs, mid-size CROs, dedicated Phase I providers, and Academic Medical Centers.
2. Selection of Phase I Service Providers – This section explores sponsor preference for 22 different service
providers as well as the strategies behind outsourcing both simple and very complex Phase I studies. We
highlight which provider attributes stand out as being important in provider selection for a very complex study as
well as critical attributes considered when searching for a provider for a simple study.
3. Geographical Analysis – ISR details the current geographic market for Phase I studies and what changes
sponsors expect to see in this landscape in upcoming years.
4. Appendix of Charts and Graphs – As always, ISR includes the responses to all questions asked in this study in the
Appendix of Charts and Graphs.

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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://isrreports.com/industry-reports/2013-phase-i-study-trends-and-mar-
ket-outlook

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Sample Page
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8
Phase
I
Market
Dynamics
Study
Volume
Pharma
and
Biotech
respondents
predict
that
their
volume
of
Phase
I
studies
will
increase
over
the
next
three
years.
“About
how
many
Phase
I
studies
would
you
estimate
your
company
conducts
on
average
per
year
/
3
years
from
now?
Your
best
estimate
is
fine.”
(Base
=
118)
Phase
I
Study
Volume
Biotechs
with
smaller
(<$500M)
R&D
budgets
predict
that
they
will
nearly
double
their
number
of
Phase
I
studies
while
Pharma
companies
with
smaller
(<$500M)
R&D
budgets
predict
substantial
year
over
year
growth
as
well.
The
bulk
of
the
volume
of
additional
studies,
however,
will
continue
to
come
from
the
larger
pharma
and
biotech
companies.
19.6
15.6
0
5
10
15
20
Eshmated
#
of
Studies
in
3
Years
Current
#
of
Studies
#
of
Studies
Main
forces
leading
to
increased
volume:
pipeline
success,
funding
increases
92%
22%
69%
27%
0%
50%
100%
150%
Biotech
R&D
<$500M
(Base=21)
Biotech
R&D
$500M+
(Base=8)
Pharma
R&D
<$500M
(Base=28)
Pharma
R&D
$500M+
(Base=61)
3
Year
Eshmated
Phase
I
Growth
Current
Avg.
#
of
Studies
25.0
6.3
13.4
1.7
© 2013 Industry Standard Research
Biotechs with smaller (<$500M) R&D budgets predict that they will nearly double their
number of Phase I studies by 2016.
Phase I Market Dynamics
Study Volume
Data available in full report

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Sample Page
Full table of contents and additional sample pages available in the full preview,
free on our website:
http://isrreports.com/industry-reports/2013-phase-i-study-trends-and-mar-
ket-outlook

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Ordering Information
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
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About Industry Standard Research
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ket-outlook