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EW
PR
EV
I

2013 CRO Quality
Benchmarking – Phase IV
Service Providers

Info@ISRreports.com 	
	

	

©2013 Industry Standard Research

www.ISRreports.com
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Report Overview
Industry Standard Research’s (ISR) “2013 CRO Quality Benchmarking – Phase IV Service Providers” report
provides pharmaceutical sponsors and clinical service providers an independent and comprehensive analysis
of CRO service quality to assist with the outsourcing of Phase IV clinical trial activities.
This year, ISR’s Phase IV report includes data from 208 unique service evaluations across 27 Phase IV
service providers.

Q4,
2013

Publication date

Report Structure:
1. Outsourcing Behaviors, Attitudes, Beliefs, and Intentions
•	
•	
•	
•	

Phase IV Leaders
Proposal Volume
Service Provider Usage
Service Provider Cost Perceptions

106

2. Sponsors’ Service Provider Selection Drivers

208

3. Service Provider Performance and Scorecards

Respondents

Service Encounters

221

Charts and Graphs

138
Pages

•	 Most Important Service Provider Attributes
•	 Service Provider Attributes Gaining Importance
•	 “Staff Characteristics” Ratings
•	 “Operational Excellence” Ratings
•	 “Organizational & Finance” Ratings

4. Satisfaction, Customer Loyalty, and the Expectations and
Performance Index (EPI™)
5. Company Service Quality Profiles
6. Study Data

What you will learn in this report:
•	
•	
•	

Performance of 27 Phase IV CROs, 7 of which received in-depth profiles, measured across 26
critical dimensions of service quality
How sponsors make their clinical outsourcing decisions, including which service attributes drive selection
Study sponsors’ satisfaction, willingness to recommend, and likelihood of repeat use for the 27
included Phase IV CROs

How you can use this report:
For study sponsors, this report offers insight into CRO service quality and empowers you to make more
informed late phase outsourcing decisions by providing evaluation and selection tools that will lead to
better service experiences.
For clinical service providers, this report offers insight into your service quality and your competitors’
quality that will allow you to compete more effectively, deliver higher quality services, and better
understand the needs of your customers.

Learn how you can use this report.
www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers

2
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Report Metrics
CROs Included in this Report
•	
•	
•	
•	
•	
•	
•	
•	
•	

Accelovance
Aptiv Solutions
BioClinica
Charles River Laboratories
Chiltern
Cognizant
Covance
DaVita Clinical Research
DCRI – Duke

•	
•	
•	
•	
•	
•	
•	
•	
•	

Eurofins
ICON
INC Research
inVentiv Health
Medpace
Novella
PAREXEL
PPD
PRA

•	
•	
•	
•	
•	
•	
•	
•	
•	

Premier Research
Quintiles
Mapi
RPS
SGS
Tata
Theorem
UBC
Worldwide Clinical Trials

Service Quality Metrics
Staff Characteristics

Operational Excellence

•	
•	
•	
•	
•	
•	
•	

•	
•	
•	
•	
•	
•	
•	
•	
•	
•	
•	
•	
•	

Commercial market knowledge
CRA quality
Minimizing staff turnover
Project manager quality
Project team chemistry
Therapeutic expertise
Timely project communications

Organization & Finance Characteristics
•	
•	
•	
•	
•	
•	

Breadth of services
Financial strength / stability
Global footprint
Low cost
Minimizing change orders
Overall value

Data quality metrics
Local market / regulatory knowledge
Meeting database lock timelines
Meeting first patient / first visit timelines
Meeting overall project timelines
Network of sites / investigators
Offers innovative solutions
Patient / volunteer recruitment strategy
Positive experience with service provider
Speed of site / investigator recruitment
Speed of site start-up
Technology for real-time access to data
Up-front contingency planning and trial risk
management

Respondent Demographics (N=106)
Participant Job Title

Participant Geography

6% C-level
4% President
9% Vice President
48% Director
28% Manager
5% Other

65%
North
America

Participant Company Size
59% Large Companies
(R&D $1B or more)

22%
Europe
13%

Asia/
Middle East/
India

27% Mid-Size
Companies (R&D
$100M-$999M)
13% Small Companies
(R&D less than $100M)

Participant Experience: Mean = 15.5 years
Up next: Full table of contents and sample pages
www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers

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Table of Contents
Full table of contents and additional sample pages are available in the full preview. Download it on our website: http://www.isrreports.com/product/2013cro-quality-benchmarking-phase-iv-service-providers/

www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers

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Report Introduction
Introduction

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Introduction
Welcome to the 2013 edition of the clinical trial and pharmaceutical environment is
One way to think about the Russian CRO Quality Benchmarking report for Phase
IV serviceof the country as a publically traded pharmaceutical pride in itsIf you of CRO
to think providers. Industry Standard Research (ISR) takes company� suite were
leafing through a prospectus or an this report, dedicated to would find a comQuality Benchmarking Reports andinvestor presentation, you the Phase IV industry, is
pany with strong macro fundamentals, information and has two very simple missions:
no different. This report has a wealth ofhistoric growth, inconsistent performance,
and some regulatory uncertainty� In short, Russia has many of the same characteristics as a mid-stage pharmaceutical company� And, if you take a portfolio theory
approach to investing, you would likely want to invest some portion of your assets
1.in Russia� Why? companies make more informed CRO selection decisions
Help sponsor

Yes, in one sense service quality depends almost solely on the people who
th
↑ Macroeconomics: sponsor’s world’s manager, economy
deliver the study - theRussia is theproject 10 largest the CRO’s project manager,
engaged clinical recognition: Joined the World Trade Organization (WTO) in 2012
↑ International investigators, diligent CRAs, etc. And if you get a different
study team each time you buy that company’s services, shouldn’t you expect
↑ Positive balance sheet: Russia has ~$240B trade surplus from fossil fuel reserves
service quality to fluctuate? And if industry turnover is high and CROs simply
↑ important staff back and forth, shouldn’t we expect any differences in
pass Focus: Putin announced $3�9B plan aimed at having 90% of medicines to be
locally produced by 2020
delivery quality between and among service providers to simply wash out over
time? But that’s notstructure: Medicines Insurance System providers. is to be in
↑ Reimbursement what happens. At least not for all (Aug 2012) CRO personnel
place by 2020 that infrastructure, processes, training, SOPs, learning and
are supported by sites,will include a tiered rate of reimbursement, depending on
the nature of the illness, and dynamics, and endless other
development budgets, cultural improve access to medications factors that lead to
some organizations pharmaceutical market has been growing 17% annually since
↑ Growth: Russian being meaningfully more effective than others. And some
organizations that simply rise and fall with the tide.
2005
ISR’s Untapped potential: Manyare designed to be smart enough to capture these
↑ Benchmarking studies patients are treatment naïve, offering opportunities
nuances and help to create a more educated buying audience.
for clinical trial patient recruitment
↓ Uncertainty: Regulatory environment and customs practices are unstable and

2. Help service providers optimize Operational and Marketing strategies
unpredictable

↓ Difficult: In 2012 what it does not know is broken. While it of economies
A company can’t fix the World Bank ranked Russia 122nd on their listis almost certainly
by ease of doing business, 21 spots below China
true that you (or your sales teams) speak with your customers and have a sense
of the levels of satisfaction / dissatisfaction with your services, it is just as certain
↓ Skills: Finding highly qualified healthcare professionals can be difficult
that you’re seeing half of the picture. Not every customer tells you the whole
↓ Protection: IP protection is concerning
story. Some will make clear to you any and all delivery shortcomings. Some
will stop short of full disclosure for various reasons. Some will leave dissatisfied
without saying a word. And some will leave dissatisfied and say a lot of words...
sometimes to their colleagues.

It’s also important to know what your company is up against from a competitive
standpoint. Yes, your company’s ratings may represent opportunities to improve
delivery and loyalty, but they might also represent opportunities to tout your
leadership and strength on traits that sponsors highly value.

www.ISRreports.com ©2013 | Russia: Clinical Development Country Profile

7

www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers

5
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Sample Page
	
  

Most	
  Important	
  Service	
  Provider	
  Attributes	
  
“Please	
  review	
  the	
  following	
  attributes	
  and	
  select	
  the	
  5	
  most	
  important	
  to	
  you	
  when	
  selecting	
  a	
  
provider	
  for	
  Phase	
  IV	
  services.”	
  (Base	
  =	
  106)	
  
“Among	
  the	
  following	
  attributes,	
  please	
  select	
  the	
  1	
  most	
  important	
  to	
  you	
  when	
  selecting	
  a	
  
provider	
  for	
  Phase	
  IV	
  services.”	
  (Base	
  =	
  106)	
  	
  
1%	
  

Breadth	
  of	
  services	
  

13%	
  
5%	
  

Change	
  order	
  minimizanon	
  metrics	
  

10%	
  

3%	
  

Commercial	
  market	
  knowledge	
  

20%	
  

5%	
  

CRA	
  quality	
  

13%	
  

4%	
  

Data	
  quality	
  metrics	
  
Detailed	
  plan	
  for	
  nmely	
  project	
  communicanons	
  

5%	
  

Financial	
  strength/	
  stability	
  

18%	
  

5%	
  
5%	
  

10%	
  

2%	
  

Global	
  footprint	
  

24%	
  

5%	
  

Local	
  market	
  /	
  Regulatory	
  knowledge	
  

38%	
  
9%	
  

Low	
  cost	
  
Metrics	
  for	
  database	
  lock	
  nmelines	
  
Metrics	
  for	
  first	
  panent	
  /	
  first	
  visit	
  nmelines	
  

5%	
  
4%	
  

Metrics	
  for	
  meenng	
  overall	
  project	
  nmelines	
  

4%	
  

53%	
  

5%	
  
4%	
  

1%	
  

Metrics	
  for	
  site	
  /	
  Invesngator	
  recruitment	
  

16%	
  

Most	
  Important	
  

5%	
  

Top	
  5	
  

5%	
  
3%	
  

Metrics	
  for	
  site	
  start-­‐up	
  

3%	
  

Network	
  of	
  sites/	
  invesngators	
  

25%	
  

3%	
  

Offers	
  innovanve	
  solunons	
  

15%	
  
36%	
  

Overall	
  value	
  
3%	
  

Panent/	
  volunteer	
  recruitment	
  strategy	
  

22%	
  
12%	
  

Prior	
  posinve	
  experience	
  with	
  service	
  provider	
  
Project	
  manager	
  quality	
  

6%	
  

Project	
  team	
  chemistry	
  

29%	
  
Data has been alphabetized. Data
available 25%	
   report.
in full

5%	
  
5%	
  
1%	
  

Staff	
  turnover	
  metrics	
  

6%	
  

Technology	
  for	
  real-­‐nme	
  access	
  to	
  data	
  

5%	
  

Therapeunc	
  expernse	
  

5%	
  
4%	
  

Up-­‐front	
  connngency	
  planning,	
  risk	
  management	
  	
  
0%	
  

	
  

69%	
  

9%	
  
40%	
  
17%	
  

25%	
  

50%	
  

75%	
  
43	
  

www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers

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Sample Company Profile
Full table of contents and additional sample pages are available in the full preview. Download it on our website: http://www.isrreports.com/product/2013cro-quality-benchmarking-phase-iv-service-providers/

www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers

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Ordering Information
For pricing and ordering information, please visit our website: http://www.
isrreports.com/product/2013-cro-quality-benchmarking-phase-iv-serviceproviders/

www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers

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The ISR Difference

act with confidence

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

vs.

Undisclosed
methodologies and
respondent demographics

Sample Sizes

Robust sample sizes that
instill confidence

vs.

Often insufficient industry
representation that leaves you
defending results

Analysts
Decades of experience
means more insights that are
immediately usable

vs.
vs.

Junior analysts capable of
reporting numbers

www.ISRreports.com ©2013 | ©2013 | Preview of: Benchmarking the Pharma Industry’sService Functions
www.ISRreports.com Preview of: 2013 CRO Quality Benchmarking – Phase IV HEOR Providers

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2013 CRO Quality Benchmarking – Phase IV Service Providers

  • 1. EW PR EV I 2013 CRO Quality Benchmarking – Phase IV Service Providers Info@ISRreports.com ©2013 Industry Standard Research www.ISRreports.com
  • 2. act with confidence Report Overview Industry Standard Research’s (ISR) “2013 CRO Quality Benchmarking – Phase IV Service Providers” report provides pharmaceutical sponsors and clinical service providers an independent and comprehensive analysis of CRO service quality to assist with the outsourcing of Phase IV clinical trial activities. This year, ISR’s Phase IV report includes data from 208 unique service evaluations across 27 Phase IV service providers. Q4, 2013 Publication date Report Structure: 1. Outsourcing Behaviors, Attitudes, Beliefs, and Intentions • • • • Phase IV Leaders Proposal Volume Service Provider Usage Service Provider Cost Perceptions 106 2. Sponsors’ Service Provider Selection Drivers 208 3. Service Provider Performance and Scorecards Respondents Service Encounters 221 Charts and Graphs 138 Pages • Most Important Service Provider Attributes • Service Provider Attributes Gaining Importance • “Staff Characteristics” Ratings • “Operational Excellence” Ratings • “Organizational & Finance” Ratings 4. Satisfaction, Customer Loyalty, and the Expectations and Performance Index (EPI™) 5. Company Service Quality Profiles 6. Study Data What you will learn in this report: • • • Performance of 27 Phase IV CROs, 7 of which received in-depth profiles, measured across 26 critical dimensions of service quality How sponsors make their clinical outsourcing decisions, including which service attributes drive selection Study sponsors’ satisfaction, willingness to recommend, and likelihood of repeat use for the 27 included Phase IV CROs How you can use this report: For study sponsors, this report offers insight into CRO service quality and empowers you to make more informed late phase outsourcing decisions by providing evaluation and selection tools that will lead to better service experiences. For clinical service providers, this report offers insight into your service quality and your competitors’ quality that will allow you to compete more effectively, deliver higher quality services, and better understand the needs of your customers. Learn how you can use this report. www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers 2
  • 3. act with confidence Report Metrics CROs Included in this Report • • • • • • • • • Accelovance Aptiv Solutions BioClinica Charles River Laboratories Chiltern Cognizant Covance DaVita Clinical Research DCRI – Duke • • • • • • • • • Eurofins ICON INC Research inVentiv Health Medpace Novella PAREXEL PPD PRA • • • • • • • • • Premier Research Quintiles Mapi RPS SGS Tata Theorem UBC Worldwide Clinical Trials Service Quality Metrics Staff Characteristics Operational Excellence • • • • • • • • • • • • • • • • • • • • Commercial market knowledge CRA quality Minimizing staff turnover Project manager quality Project team chemistry Therapeutic expertise Timely project communications Organization & Finance Characteristics • • • • • • Breadth of services Financial strength / stability Global footprint Low cost Minimizing change orders Overall value Data quality metrics Local market / regulatory knowledge Meeting database lock timelines Meeting first patient / first visit timelines Meeting overall project timelines Network of sites / investigators Offers innovative solutions Patient / volunteer recruitment strategy Positive experience with service provider Speed of site / investigator recruitment Speed of site start-up Technology for real-time access to data Up-front contingency planning and trial risk management Respondent Demographics (N=106) Participant Job Title Participant Geography 6% C-level 4% President 9% Vice President 48% Director 28% Manager 5% Other 65% North America Participant Company Size 59% Large Companies (R&D $1B or more) 22% Europe 13% Asia/ Middle East/ India 27% Mid-Size Companies (R&D $100M-$999M) 13% Small Companies (R&D less than $100M) Participant Experience: Mean = 15.5 years Up next: Full table of contents and sample pages www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers 3
  • 4. act with confidence Table of Contents Full table of contents and additional sample pages are available in the full preview. Download it on our website: http://www.isrreports.com/product/2013cro-quality-benchmarking-phase-iv-service-providers/ www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers 4
  • 5. act with confidence Report Introduction Introduction act with confidence Introduction Welcome to the 2013 edition of the clinical trial and pharmaceutical environment is One way to think about the Russian CRO Quality Benchmarking report for Phase IV serviceof the country as a publically traded pharmaceutical pride in itsIf you of CRO to think providers. Industry Standard Research (ISR) takes company� suite were leafing through a prospectus or an this report, dedicated to would find a comQuality Benchmarking Reports andinvestor presentation, you the Phase IV industry, is pany with strong macro fundamentals, information and has two very simple missions: no different. This report has a wealth ofhistoric growth, inconsistent performance, and some regulatory uncertainty� In short, Russia has many of the same characteristics as a mid-stage pharmaceutical company� And, if you take a portfolio theory approach to investing, you would likely want to invest some portion of your assets 1.in Russia� Why? companies make more informed CRO selection decisions Help sponsor Yes, in one sense service quality depends almost solely on the people who th ↑ Macroeconomics: sponsor’s world’s manager, economy deliver the study - theRussia is theproject 10 largest the CRO’s project manager, engaged clinical recognition: Joined the World Trade Organization (WTO) in 2012 ↑ International investigators, diligent CRAs, etc. And if you get a different study team each time you buy that company’s services, shouldn’t you expect ↑ Positive balance sheet: Russia has ~$240B trade surplus from fossil fuel reserves service quality to fluctuate? And if industry turnover is high and CROs simply ↑ important staff back and forth, shouldn’t we expect any differences in pass Focus: Putin announced $3�9B plan aimed at having 90% of medicines to be locally produced by 2020 delivery quality between and among service providers to simply wash out over time? But that’s notstructure: Medicines Insurance System providers. is to be in ↑ Reimbursement what happens. At least not for all (Aug 2012) CRO personnel place by 2020 that infrastructure, processes, training, SOPs, learning and are supported by sites,will include a tiered rate of reimbursement, depending on the nature of the illness, and dynamics, and endless other development budgets, cultural improve access to medications factors that lead to some organizations pharmaceutical market has been growing 17% annually since ↑ Growth: Russian being meaningfully more effective than others. And some organizations that simply rise and fall with the tide. 2005 ISR’s Untapped potential: Manyare designed to be smart enough to capture these ↑ Benchmarking studies patients are treatment naïve, offering opportunities nuances and help to create a more educated buying audience. for clinical trial patient recruitment ↓ Uncertainty: Regulatory environment and customs practices are unstable and 2. Help service providers optimize Operational and Marketing strategies unpredictable ↓ Difficult: In 2012 what it does not know is broken. While it of economies A company can’t fix the World Bank ranked Russia 122nd on their listis almost certainly by ease of doing business, 21 spots below China true that you (or your sales teams) speak with your customers and have a sense of the levels of satisfaction / dissatisfaction with your services, it is just as certain ↓ Skills: Finding highly qualified healthcare professionals can be difficult that you’re seeing half of the picture. Not every customer tells you the whole ↓ Protection: IP protection is concerning story. Some will make clear to you any and all delivery shortcomings. Some will stop short of full disclosure for various reasons. Some will leave dissatisfied without saying a word. And some will leave dissatisfied and say a lot of words... sometimes to their colleagues. It’s also important to know what your company is up against from a competitive standpoint. Yes, your company’s ratings may represent opportunities to improve delivery and loyalty, but they might also represent opportunities to tout your leadership and strength on traits that sponsors highly value. www.ISRreports.com ©2013 | Russia: Clinical Development Country Profile 7 www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers 5
  • 6. act with confidence Sample Page   Most  Important  Service  Provider  Attributes   “Please  review  the  following  attributes  and  select  the  5  most  important  to  you  when  selecting  a   provider  for  Phase  IV  services.”  (Base  =  106)   “Among  the  following  attributes,  please  select  the  1  most  important  to  you  when  selecting  a   provider  for  Phase  IV  services.”  (Base  =  106)     1%   Breadth  of  services   13%   5%   Change  order  minimizanon  metrics   10%   3%   Commercial  market  knowledge   20%   5%   CRA  quality   13%   4%   Data  quality  metrics   Detailed  plan  for  nmely  project  communicanons   5%   Financial  strength/  stability   18%   5%   5%   10%   2%   Global  footprint   24%   5%   Local  market  /  Regulatory  knowledge   38%   9%   Low  cost   Metrics  for  database  lock  nmelines   Metrics  for  first  panent  /  first  visit  nmelines   5%   4%   Metrics  for  meenng  overall  project  nmelines   4%   53%   5%   4%   1%   Metrics  for  site  /  Invesngator  recruitment   16%   Most  Important   5%   Top  5   5%   3%   Metrics  for  site  start-­‐up   3%   Network  of  sites/  invesngators   25%   3%   Offers  innovanve  solunons   15%   36%   Overall  value   3%   Panent/  volunteer  recruitment  strategy   22%   12%   Prior  posinve  experience  with  service  provider   Project  manager  quality   6%   Project  team  chemistry   29%   Data has been alphabetized. Data available 25%   report. in full 5%   5%   1%   Staff  turnover  metrics   6%   Technology  for  real-­‐nme  access  to  data   5%   Therapeunc  expernse   5%   4%   Up-­‐front  connngency  planning,  risk  management     0%     69%   9%   40%   17%   25%   50%   75%   43   www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers 6
  • 7. act with confidence Sample Company Profile Full table of contents and additional sample pages are available in the full preview. Download it on our website: http://www.isrreports.com/product/2013cro-quality-benchmarking-phase-iv-service-providers/ www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers 7
  • 8. act with confidence Ordering Information For pricing and ordering information, please visit our website: http://www. isrreports.com/product/2013-cro-quality-benchmarking-phase-iv-serviceproviders/ www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase IV Service Providers 8
  • 9. The ISR Difference act with confidence 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 vs. Undisclosed methodologies and respondent demographics Sample Sizes Robust sample sizes that instill confidence vs. Often insufficient industry representation that leaves you defending results Analysts Decades of experience means more insights that are immediately usable vs. vs. Junior analysts capable of reporting numbers www.ISRreports.com ©2013 | ©2013 | Preview of: Benchmarking the Pharma Industry’sService Functions www.ISRreports.com Preview of: 2013 CRO Quality Benchmarking – Phase IV HEOR Providers 9