In the face of cost and regulatory pressures, clinical programs at pharmaceutical organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets. However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions. Best Practices®, LLC conducted primary research to inform clinical affairs leaders at pharmaceutical companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions. Critical outsourcing questions addressed in this survey include: -What are the regions where pharmaceutical companies are conducting clinical trials and the percent of patients recruited annually from these regions? -Which clinical trial activities are best suited for outsourcing? -What is the appropriate staffing mix (in-house and outsourced) for clinical trials? -What are the most important competencies for clinical research associates, managers, and directors? This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.

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Best Practices, LLC Strategic Benchmarking Research
Clinical Affairs Excellence:
Benchmarking Clinical Trial Strategies for
Pharmaceutical Success in a Global Marketplace

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TABLE OF CONTENTS
I. Executive Brief, Framework for Clinical, Preparing Clinical, p.2-3
II. Executive Summary
 Business Issue and Project Blueprint, p.6-7
 Participants, p.8
 Key Findings, p.9-12
III. Outside-U.S. Clinical Trial Overview and Insights, p.13-17
IV. Clinical Affairs Budget and FTEs, p. 18-25
V. Clinical Affairs Presence Around the World, p.26-30
VI. Cost and Quality of Outside-U.S. Trials and Outsourcing, p.31-37
VII. Outsourcing Levels for Key Clinical Activities, p.38-47
VIII. Vendor Selection and Outsourcing Attributes, p.48-54
IX. CRA, CRM, and CRD Competencies & Outsourcing Levels, p. 55-64
X. Clinical Affairs Organizational Fit, p.65-72
XI. Outsourcing Success Factors and Pitfalls, p. 73-75
XII. Trends and Directions for Outside-U.S. Trials & Outsourcing, p.76-78
XIII. Appendix, p. 79-81
XIV. About Best Practices, LLC, p.82

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Formulate a Strategic
Approach for Engaging
Emerging Regions in Clinical
Affairs Activities
Business Issue & Objectives
Objectives:
 Determine the regions where pharma organizations conduct clinical trials and percent
of patients recruited annually from each region.
 Identify which Clinical Affairs activities are best suited to be outsourced or kept in-
house.
 Gauge what the experience of pharma organizations has been relative to the cost of
outsourcing clinical trial activities.
 Rate the value of benefits associated with outsourcing clinical trial activities.
Best Practices, LLC conducted this benchmarking study to help biopharma organizations
set a strategic direction for conducting clinical trial activities in emerging regions of the
world.
Field Research & Insight Development:
Survey 7 clinical leaders at 6 pharma companies.
Conduct four executive interviews to collect
qualitative insights from selected survey participants.
INFORM
Objective:

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Directors &
Senior
Directors
71%
Head of
Clinical
Operations
29%
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Pharma Universe of Learning: Leveraging Group Knowledge
(n = 7)
Respondent Job Level
Seven participants from six pharmaceutical companies participated. The study attracted a
strong group of experienced pharmaceutical Clinical Affairs executives. Two were at the
vice president level and five were at the director level.
Companies
Pharma Segment

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Q. What were the approximate total 2010 revenues for your company and the corresponding Clinical
Affairs Spend?
Estimated Revenue
($USD):
Clinical Affairs Spend
($USD):
Clinical Affairs Spend/
Company Revenue:
Max - - -
Mean $14,760,000,000 $460,500,000 7.43%
Median $7,000,000,000 $315,000,000 6.15%
Min - - -
Pharma Segment: Revenue and Clinical Affairs Spend
Pharma Segment: Average Revenue $14B with $460M Clinical Budget
An outlier pushed the pharmaceutical segment’s average Clinical Affairs budget to 7
percent of an organizations total revenues. Due to the outlier effect, a more comparative
measure may be the median, which had clinical affairs budget representing 6 percent of
organizations’ overall revenues.
(n = 5 4 4)
(Note : able to report mean and median only)

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Outsourced
60%
Offshored
6%
Insourced
34%
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Q. What is the approximate staff sourcing percentage mix of Clinical Trials conducted across your
global enterprise in terms of % In sourced Staffing, % Offshore Staffing, and % Outsourced Staffing
(n = 6)
In sourced
Staffing of
Clinical
Affairs/
Clinical Trials
Offshore
Staffing
Clinical
Affairs/
Clinical Trials
Outsourced
Staffing of
Clinical
Affairs/
Clinical Trials
Max 70% 15% 80%
Mean 34% 6% 60%
Median 30% 5% 60%
Min 15% 0% 30%
Average Staff Sourcing MixStaff Sourcing Mix Pharma
Pharma Segment: Staff Resourcing Mix
Pharma Segment: Most Trial Staff Outsourced
Pharma participants said 60 percent of their clinical trial staff are outsourced, on average.
In-house staff represented only a third of the staff devoted to clinical trials. The pharma
sector has seized on use of CROs as a way to reduce long-term clinical costs.

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Q. In general, how do regulatory authorities react to clinical trial data from research conducted
outside the U.S.?
(n = 7)
Few
questions
about data
43%
Extensive
conversations
about data
29%
No
questions
14%
Other
14%
Other:
• “No Phase IV trial
conducted
outside the US
requiring label
change.”
Pharma Segment: Reaction of Regulators to Outside-US Clinical Trial Data
Pharma participants appeared more comfortable with data from trials conducted outside
the U.S. Fifty-seven percent of the pharma segment felt regulators had few to no
questions about data from outside regions. Still, a third felt the data led to extensive
conversations.
Pharma Segment Sees Few to No Questions on Data

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Q. By clinical affairs activity, note the percent of activities that outsourced and the percent that are
handled in-house (Total of each row = 100%).
Pharma Segment: Outsourced vs. In-house Breakdown Summary
70%
52%
68%
74%
78%
60%
60%
30%
48%
32%
26%
22%
40%
40%
Site Mangement
Data Analysis
Trial Management
Patient Enrollment
Data Management
Investigator
Recruitment
Site Evaluation
Outsourced In-house
Pharma Segment: Clinical Activities Overview Shows
Outsourcing a Major Tool for All Key Activities
This slide presents an overview of pharma participants’ outsourcing levels for seven key
Clinical activities. Participants outsource a majority of the tasks associated with each
activity. The activities with the most outsourcing are data management and patient
enrollment.
n =
6
6
5
5
5
5
3

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Highly Inaccurate Somewhat Inaccurate Inconsistent Somewhat Accurate Highly Accurate
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Q. If you outsource, what capabilities are best predictors that the your outsource vendor will
provide a high quality service that meets your expectations:
(n = 5)
Pharma Segment: Predictors of Vendor Quality
Pharma Segment: Staff Experience Best Vendor Predictor
Pharma participants felt that the best quality predictor of an outsourcing vendor was the
experience of its staff. The vendor’s track record in the target geography and its staff turn-
over rate also were viewed as valuable indicators.
20%
20%
20%
20%
20%
60%
80%
80%
60%
80%
40%
20%
20%
40%
20%Educational credentials
Proven track record in therapeutic
area
Tenure of their staff
Turn-over rates of their staff
Proven track record in the
geography
Experience of staff in relevant areas

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Successful CRO has Local Office & Strong Management
When considering a CRO for a device trial in an emerging market, two of the most critical
traits to look for are 1) Experience in that region and preferably a local office there and 2)
Strong management, both at its main office and at the local office in the market where
you want to do a trial.
• The CRO should have a main office in your geography so you can
manage them, but CRO also needs to have office in emerging area
so they have local presence. “So they can do the local work but then
we can still drive our timelines and push from here. It’s hard to push a
CRO when you can’t get over to their office quickly – they’re too far
away.”
• The CRO has to have experience in the geographic region
• The CRO has to have people knowledgeable in the management side
of clinical trials and have strong local management as well. “If they
don’t have a strong manager in that local area that knows what it
takes to get clinical trials done, it’s not going to work.”
Don’t…
• Automatically assume a U.S. CRO has a presence in an emerging
market because they say they can work there. That may translate to
we’ll hire another, locally based CRO to do our work.
“We had a CRO running a global
project that did not include Japan
and China – it was a huge project.
That same company was also
helping us run a Japan trial. It was
night and day difference and it
was all because we had very good
management on the global project
and poor management on the
Japan trial.”
– Director, Global Clinical
CRO Dos and Don’ts
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Q. What are the three most valuable lessons learned or critical success factors to make clinical
affairs outsourcing work?
Pharma Segment: Critical Success Factors/Lessons Learned
Pharma: Critical Success Factors/ Lessons Learned
(n = 4)
Pharma participants felt the critical success factors behind successful clinical outsourcing
were communication, a dedicated outsourcing group, appropriate oversight and
established relationships.

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About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts
work based on the simple yet profound principle that organizations
can chart a course to superior economic performance by studying
the best business practices, operating tactics and winning
strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
919-403-0251
best@best-in-class.com
www.best-in-class.com