2013 CRO Quality Benchmarking – Phase I
Service Providers
©2013 Industry Standard Research www.ISRreports.com
PREVIEW
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Report Overview
Q3, 2013
Publication date
110Respondents
360 Service Encounters
234 Charts and Graphs
132Pages
In its 5th year, ISR’s “CRO Quality Benchmarking” series provides the pharmaceutical industry with a
unique resource to evaluate and select CROs, while offering clinical service providers valuable insight
into their service quality, their competitors’ service quality, and their customers’ outsourcing behaviors.
This year, ISR’s Phase I report includes data from 360 unique service evaluations across 23 Phase I service providers.
Major Sections:1. Outsourcing Behaviors, Attitudes, Beliefs, and Intentions
• Phase I Leaders• Proposal Volume• Service Provider Usage• Service Provider Cost Perceptions
2. Service Provider Selection Drivers• Most Important Service Provider Attributes• Service Provider Attributes Gaining Importance
3. Service Provider Performance and Scorecards across Attributes• “Staff Characteristics” Ratings• “Operational Excellence” Ratings• “Organizational and Financial” Ratings
4. Satisfaction, Customer Loyalty, and the Expectations andPerformance Index (EPI™)
5. Service Provider Service Quality Profiles
6. Study Data
What you will learn in this report:
CRO Service Quality Ratings: ISR surveys CROs’ past customers to compile hundreds of quantitative service quality ratings across 23 clinical service providers.
Phase Specific Outsourcing Behaviors and Trends: Decision-makers from over 100 global pharmaceutical and biotech companies provide insight into their clinical outsourcing practices and strategies.
How you can use this report:
For study sponsors, these reports offer insight into CRO service quality and empower you to make more informed clinical outsourcing decisions, select smarter, build stronger relationships, and have better service experiences.
For clinical service providers, these critical reports allow your organization to deliver higher quality services, compete more effectively, and better meet the needs of your customers.
For report metrics and respondent demographics, see next page.
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Report Metrics
Respondent Demographics
• CEDRA• Celerion• Charles River• Chiltern• Covance• DaVita
• DCRI-Duke• ICON• INC Research• InVentiv Health Clinical• Medpace• PAREXEL
• PPD• PRA• PRACS Institute• Premier Research• Quintiles• Rho
• SGS Life Sciences• Siro Clinpharm• Theorem• US Oncology• West Coast Clinical
Trials
Operational Excellence
• Data quality
• Local Market / Regulatory Knowledge
• Meeting overall project timelines
• Meeting database lock timelines
• Meeting first patient / first visit timelines
• Offers Innovative Solutions
• Patient/ volunteer recruitment
• Speed of site / Investigator recruitment
• Speed of site start-up
• Technology for real-time access to data
• Timely project communications
• Up-front Contingency Planning and Trial Risk Management
Organization & Finance Characteristics
• Access to “unique” tests, machines, equipment
• Access to a broad range of services beyond clinic / volunteer management
• Access to patient populations
• Financial strength/ stability
• Location of Phase I unit(s) within your country
• Location of Phase I unit(s) in different global regions
• Low Cost
• Minimizing change orders
• Positive experience with service provider
• Timely access to open bed / clinic space
Staff Characteristics
• Experience of the Phase I unit’s lead investigator
• Therapeutic expertise
• Minimizing staff turnover
• Project team chemistry
• Project manager quality
• Scientific knowledge
Service Quality Metrics:
CROs Included in this Report:
66%North America
22%Europe
11%Asia
Participant Geography:
Participant Experience: Mean = 17.1 Years
Participant Company Size
29% Small Companies (R&D less than $100M)
26% Mid-Size Companies (R&D $100M-$999M)
45% Large Companies (R&D $1B or more)
Participant Job Title
45% Director
20% Manager
17% Vice President
5% Other
3% President
9% C-level
Why is this important?
Learn which CROs have proven leadership in
accessing healthy volunteers and patient populations
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Table of Contents
Copyright and Usage Guidelines
Introduction
Methodology
Respondent Demographics
Participant Years of Industry Experience
Participant Geography
Number of Ratings per Company
Major sections
Outsourcing Behaviors, Attitudes, Beliefs, and
Intentions
Phase I Leaders, unprompted
Phase I Leaders, Prompted
Received Proposals
Service Provider Usage
Service Provider Cost Perceptions
Service Provider Selection Drivers
Most Important Service Provider Attributes
Service Provider Attributes Gaining Importance
Service Provider Performance and Scorecards across
Attributes
Figure 1 – “Staff Characteristics” Ratings
Figure 2 – “Operational Excellence” Ratings
Figure 3 – “Organizational and Finance” Ratings
Performance Summary by Category
Outcome Measures: EPI™ and Customer Loyalty
Summary of EPI™
Service Provider Loyalty – A compilation of Overall
Satisfaction, Willingness to Recommend, and Likeli-
hood to Use Again
Company Service Quality Profiles
Celerion
Charles River
Covance
ICON
InVentiv Health Clinical
Medpace
PAREXEL
PPD
PRA
PRACS Institute
Quintiles
WCCT
Study Data
Phase I
Phase I Leaders, unprompted
Phase I Leaders, Prompted
Received Proposals
Most Important Service Provider Attributes
Service Provider Attributes Gaining Importance
Service Provider Usage
Service Provider Preference
Best Service Provider at Differentiation
Service Provider Cost Experience
Service Provider Cost Experience by users of past 18
months
Summary of EPI™
Service Provider Loyalty
Service Provider Loyalty – A compilation of Overall
Satisfaction, Willingness to Recommend, and Likeli-
hood to Use Again
Overall Satisfaction with Service Providers
Willingness to Recommend Service Providers
Likelihood to Use Service Providers Again
Service Providers Drill-downs
CEDRA
Celerion
Charles River
Chiltern
Covance
DaVita
DCRI-Duke
ICON
INC Research
InVentiv Health Clinical
Medpace
PAREXEL
PPD
PRA
PRACS Institute
Premier Research
Quintiles
Rho
SGS Life Sciences
Siro Clinpharm
Theorem
US Oncology
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Table of Contents
West Coast Clinical Trials
Cross-service provider performance
Access to “unique” tests, machines, equipment
Access to a broad range of services beyond
clinic / volunteer management
Access to patient populations
Data quality
Experience of the Phase I unit’s lead investigator
Financial strength/ stability
Local market / Regulatory knowledge
Location of Phase I unit(s) in different global
region
Location of Phase I unit(s) within your country
Low cost
Meeting database lock timelines
Meeting first patient / first visit timelines
Meeting overall project timelines
Minimizing change orders
Minimizing staff turnover
Offered innovative solutions
Overall value
Patient/ volunteer recruitment
Positive experience with service provider
Project manager quality
Project team chemistry
Scientific knowledge
Speed of site / Investigator recruitment
Speed of site start-up
Technology for real-time access to data
Therapeutic expertise
Timely access to open bed / clinic space
Timely project communications
Up-front contingency planning, risk manage-
ment
Trade-Offs
Respondent Demographics
Company Type
Primary Area of Responsibility
Outsourcing Responsibility
Job Title
Recent Activity in Outsourced Activitie
Phase Responsibility
Involvement in Clinical Development Process
Years in the Industry
Location
Therapeutic Area
About Industry Standard Research
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Introduction
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Introduction
Welcome to the 2013 edition of the CRO Quality Benchmarking report for Phase I� Industry Standard Research (ISR) takes pride in its suite of CRO Quality Benchmarking Reports and this report, dedicated to the Phase I industry, is no different� This report has a wealth of information and has two very simple missions:
1. Help sponsor companies make more informed CRO selection decisions
Yes, in one sense service quality depends almost solely on the people who deliver the study - the Phase I unit’s lead investigator, the Project Manager, the Clinic Staff, etc� And if you get a different study team each time you buy that company’s services, shouldn’t you expect service quality to fluctuate? And if industry turnover is high and CROs simply pass important staff back and forth, shouldn’t we expect any differences in delivery quality between and among service providers to simply wash-out over time? But that’s not what happens� At least not for all providers� CRO personnel are supported by sites, infrastruc-ture, processes, training, SOPs, learning and development budgets, cultural dynamics, and endless other factors that lead to some organizations being meaningfully more effective than others� And some organizations that simply rise and fall with the tide�
ISR’s Benchmarking studies are designed to be smart enough to capture these nuances and help to create a more educated buying audience�
2. Help service providers optimize Operational and Marketing strategies
A company can’t fix what it does not know is broken� While it is almost cer-tainly 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 that you’re seeing half of the picture� Not every customer tells you the whole story� Some will make it clear to you any and all delivery shortcomings� Some will stop short of full disclosure for various reasons� Some will leave dis-satisfied 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�
Sample Page
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Sample Page
www.ISRreports.com © 2013 | 2013 CRO Quality Benchmarking – Phase I Service Providers 50
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Up-front contingency planning, risk management
Timely access to open bed / clinic space
Therapeutic expertise
Technology for real-time access to data
Staff turnover metrics
Scientific knowledge
Project team chemistry
Project manager quality
Prior positive experience with service provider
Patient/ volunteer recruitment strategy
Overall value
Offers innovative solutions
Metrics for site start-up
Metrics for site / Investigator recruitment
Metrics for meeting overall project timelines
Metrics for first patient / first visit timelines
Metrics for database lock timelines
Low cost
Location of Phase I unit(s) within your country
Location of Phase I unit(s) in different global regions
Local market / Regulatory knowledge
Financial strength/ stability
Experience of the Phase I unit’s lead investigator
Detailed plan for timely project communications
Data quality metrics
Change order minimization metrics
Access to patient populations
Access to a broad range of services beyond clinic /
Access to “unique” tests, machines, equipment
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“Please review the following attributes and select the 5 most important to you when selecting a provider for Phase I services.” (Base = 110) “Among the following attributes, please select the 1 most important to you when selecting a provider for Phase I services.” (Base = 110)
Data available in full report
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Sample Company Profile
Company Profiles — Sample
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PPD EPITM
PPD Expectations and Performance Index = 68 (N = 34 evaluations)
PPD Average Customer Experience
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6.3
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PPD
“unique” tests, machines, equipment Broad range of services
Therapeutic expertise
Data quality metrics
Experience of the Phase I unit’s lead investigator
Financial strength/ stability
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Database lock timelines First patient / first visit
timelines
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Change order minimization
Staff turnover metrics
Offers Innovative solutions
Overall value
Patient/ volunteer recruitment
Prior positive experience
Project manager quality
Project team chemistry
Scientific knowledge
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Site start-up
Real-time access to data
Access to patient populations
Access to open bed / clinic space
Timely project communications
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PPD Performance vs. Attribute Importance
PPD Customer Loyalty
% Rating “Meets” or “Exceeds” Expectations
% RatingAttribute
among theTop 5 MostImportant
Sample EPI™
Sample Performance vs. Attribute Importance
Sample Average Customer Experience
Sample Profile Expectations and
Performance Index = 68
(N = 34 evaluations)
Sample Highlights
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Relative Weaknesses• Low cost
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Trade-Offs “Would you prefer…?” (N = 110)
“Would you prefer…?” (N = 110)
20% lower cost of a study, 23%
Reaching patient
recruitment goals 10% faster within the study,
77%
A CRO offer you recruitment guarantees
driven by them controlling site selection, 66%
To maintain control over site
selection with no recruitment
guarantees, 34%
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“Given your company’s current unique development needs, would you prefer a service provider that almost always flawlessly executes a study based on your design, SOPs, and specifications or a service provider that can come to the table and help design the best study possible?” (Base = 110)
“Three years from now, do you think your company will need a service provider that almost always flawlessly executes a study based on your design, SOPs, and specifications or will you need a service provider that can come to the table and help design the best study possible?” (Base = 110)
Need flawless execution, 60%
Need drug development
design expertise and experience,
40%
Need flawless execution, 55%
Need drug development
design expertise and experience,
45%
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