This report offers the pharmaceutical and biotech industry, and its service providers “peer-based” guidance on the adoption, use, and outsourcing of risk-based monitoring.

1. Risk-based Monitoring:
Industry Guidance on
Adoption, Use, and
Outsourcing
Info@ISRreports.com
©2013 Industry Standard Research www.ISRreports.com
PREVIEW

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Report Overview
This report offers the pharmaceutical and biotech industry, and its service providers “peer-based” guidance on
the adoption, use, and outsourcing of risk-based monitoring.
145
pages
78
respondents
83
charts and graphs
1. Executive Summary
2. Risk-based Monitoring (RBM) Awareness and Definition
3. Best Practices & Operational Impact of RBM
4. Sponsor Perception and Use of RBM
5. Data and Technology
6. Outsourcing Environment
7. RBM Economics
8. Respondent Demographics
Major Sections:
What you will learn in this report:
• Sponsors’ interests in and use of RBM studies, why RBM is gaining momentum, what is driving
adoption, and a high-level look at sponsors’ expected financial and operational outcomes of RBM
studies
• Real-world lessons-learned, including advice for individuals and companies wanting to implement
RBM studies
• Study types that are seen as most appropriate for RBM and which departments are involved in the
planning of these studies
• On-the-ground suggestions for improving the RBM regulatory and training processes
• Which technologies are most important to running a successful RBM-based trial and which are
most difficult to implement
• The percentage of RBM studies outsourced, the preferred types of service providers, and most
important service provider attributes impacting selection
How you can use this report:
For sponsors: Use this information to help drive RBM adoption in your organization, avoid pitfalls that
might stagger RBM growth, inform your data infrastructure strategies, and benchmark the use of RBM.
For service providers: Better understand the inner working of sponsors as it relates to the adoption of
RBM models and craft better messages and service offerings to account for these views.
Valuable for:
Clinical Operations, Medical Directors, R&D Management, Therapeutic Heads, Clinical Service Providers

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Table of Contents (1 of 2)
Full table of contents, additional sample pages, and ordering infor-
mation are available in the full preview at:
http://isrreports.com/industry-reports/riskbased-monitoring-in-
dustry-guidance-on-adoption-use-and-outsourcing

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Sample Page: Report Introduction
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www.ISRreports.com ©2013 | 2013 CRO Quality Benchmarking – Phase II/III Service Providers 2
Covance
ICON
INC Research
PAREXEL
PharmaNet/i3
PPD
PRA
Quintiles
Bioclinica
DCRI-Duke
Medpace
Premier Research
RPS
SGS Life Sciences
World Wide
Clinical Trials
Minimizing
Staff
TurnoverCRA Quality
Project Team
Chemistry
Therapeutic
Expertise
Timely Project
Communications
Commercial
Market
Knowledge
Project
Manager
Quality
Staff Characteristics
Ratings Key: Clear leadership Better than most About average Falling a bit short
Local Market /
Regulatory
Knowledge
Figure 1 – “Staff Characteristics” Ratings
Responses have been
randomized. Data available in
the full report.
© 2013 Industry Standard Research
What’s in a name?
Well, if you ask marketing and branding experts, they will tell you a name can be everything. At ISR, we
have found it interesting that someone in the pharmaceutical industry named a process for monitoring
investigative sites and patient data “risk-based monitoring.” For an industry that is notoriously risk-averse
and highly regulated, we would have bet against a solution named “risk-based monitoring” gaining
traction. But it has.
ISR believes the rise of risk-based monitoring (RBM) is a result of several forces acting on the
pharmaceutical industry. First, while it has taken what seems like an eternity, electronic data capture
(EDC) technology is now the de facto standard for site/ patient data capture. Second, the patent cliff
and declining R&D productivity rates have conspired to “force” pharmaceutical companies to look at
ways to cut costs, while increasing efficiency. This has led companies to ask whether 100% source
document verification (SDV) is really necessary and whether dispatching throngs of medical monitors
has a corresponding positive impact on data quality. Third, regulators have begun to output guidance
documents that center on alternative drug development models and processes (risk-based monitoring,
adaptive trials, electronic data as source data), making it less risky for sponsors to employ these
methodologies/ strategies.
What we learned from the data in this report is that RBM is a process. The awareness of and interest in
RBM is relatively high. Sponsors are, or should be, doing their due diligence on the topic. They are looking
for both internal subject matter experts across many different disciplines within their organization and for
CROs who have experience in not only operationally executing RBM studies, but for CROs who can/ will
input on the design and strategies surrounding them.
At this point in the life cycle of RBM, planning is king.

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Sample Pages
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3%
6%
38%
44%
9%
0%
15%
30%
45%
60%
Strongly
disagree
Disagree
Neither
agree
or
disagree
Agree
Strongly
agree
Cost-benefit of risk-based monitoring
“Using the agree/disagree scale below, please indicate your agreement with the
following statement: The overall benefits of risk-based monitoring outweigh the time
and resources needed upfront to gain regulatory approval of the protocol and risk-
based monitoring plan/strategy?”
(Base = 78)
© 2013 Industry Standard Research
© 2013 Industry Standard Research

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Sample Page
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− www.isrreports.com
©2013|
Risk-­‐based
Monitoring
Market
Assessment
135
37%
23%
20%
41%
43%
36%
0%
20%
40%
60%
80%
100%
No
RBM
experience
(N=9)
RBM-­‐experienced
(N=69)
High
risk;
required
more
verificaRon/
review
Medium
risk;
requires
moderate
verificaRon/
review
Low
risk;
requires
less/
no
verificaRon/
review
26%
29%
36%
41%
38%
30%
0%
20%
40%
60%
80%
100%
No
RBM
experience
(N=9)
RBM-­‐experienced
(N=69)
High
risk;
required
more
verificaRon/
review
Medium
risk;
requires
moderate
verificaRon/
review
Low
risk;
requires
less/
no
verificaRon/
review
Investigative sites: risk-level assessment
“What percent of your investigative sites fall under the following three levels of risk?”
Clinical studies: risk-level assessment
“What percent of your studies fall under the following three levels of risk?”
© 2013 Industry Standard Research
© 2013 Industry Standard Research

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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 twitter @ISRreports.
About Industry Standard Research
Ordering Information, full table of contents, and additional sample
pages are available in the full preview at:
http://isrreports.com/industry-reports/riskbased-monitoring-in-
dustry-guidance-on-adoption-use-and-outsourcing