2013 cro quality benchmarking – phase i service...

2013 CRO Quality Benchmarking – Phase I

Service Providers

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www.ISRreports.com ©2013 | Preview of: 2013 CRO Quality Benchmarking – Phase I Service Providers 2

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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


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


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


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

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www.ISRreports.com ©2013 | 2013 CRO Quality Benchmarking – Phase I Service Providers 7

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

17%

15% 42%

11%

2%

21%

6%

26%

37%

33%

51%

19%

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Up-front contingency planning, risk management

Timely access to open bed / clinic space


Technology for real-time access to data

Staff turnover metrics




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




Detailed plan for timely project communications

Data quality metrics

Change order minimization metrics


Access to a broad range of services beyond clinic /

Access to “unique” tests, machines, equipment

Serv

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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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www.isrreports.com ©2013| 2013 CRO Quality Benchmarking – Phase I Service Providers 62

0%

20%

40%

60%

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100%

Greatly Missed Expectations

Somewhat Missed Expectations

Met Expectations Somewhat Exceeded

Expectations

Greatly Exceeded Expectations

Sample Company Modified bell curve

PPD EPITM

PPD Expectations and Performance Index = 68 (N = 34 evaluations)

PPD Average Customer Experience

SomewhatExceeds

Expectations

SomewhatMisses

Expectations

www.isrreports.com ©2013| 2013 CRO Quality Benchmarking – Phase I Service Providers 64

6.3

7.1

0 2 4 6 8 10

Industry Average

PPD

“unique” tests, machines, equipment Broad range of services


Data quality metrics




Global regions

Phase I unit(s) within your country

Low cost

Database lock timelines First patient / first visit

timelines

Meeting overall project timelines

Change order minimization

Staff turnover metrics

Offers Innovative solutions

Overall value

Patient/ volunteer recruitment

Prior positive experience




Site / Investigator recruitment

Site start-up

Real-time access to data


Access to open bed / clinic space

Timely project communications

Up-front contingency planning

0%

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66% 83% 100%

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

Relative Strengths• Data quality

• Local market/ Regulatoryknowledge

• Positive experiencewith serviceprovider

• Among the topranked for ServiceProvider Loyalty

• Among the highestfor EPI™

Relative Weaknesses• Low cost

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© 2013 Industry Standard Research

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Sample Page


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%


“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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