Phase II/III CRO Benchmarking - Worldwide Clinical Trials Company Performance Profile, Excerpt from Phase II/III CRO Benchmarking (13th Edition)
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13th Edition – April, 2021
Phase II/III CRO
Benchmarking
Worldwide Clinical Trials
Company Performance Profile, Excerpt from
Phase II/III CRO Benchmarking (13th Edition)
AUGUST, 2020Phase II/III CRO Benchmarking (13th Edition) Introduction IN THIS EXCERPT: The content for this excerpt was taken directly from Phase II/III CRO Benchmarking (13th Edition) report, April 2021. All or parts of the following sections are included in this excerpt: ISR Introduction, Methodology, Participant Criteria, Service Provider Performance and Loyalty Primary Section Takeaways, Company Service Quality Profiles, Worldwide Clinical Trials Performance Summary, Performance Across Service Providers, and About ISR. Over the past year, Covid-19 put the pharma industry between a rock and a hard place. Around the world, biochemists, scientists, doctors, researchers, and the like raced to develop a vaccine. Several vaccines have been approved for emergency authorization; manufacturing, distribution, and inoculation efforts are happening at rates never seen before. Let’s pause and take a masked breath. We at ISR are marveling over what has been done in a relatively short amount of time. We recently updated a metric that tracks clinical trial submissions – between Q1 and Q4 2020, the number of industry-sponsored submissions for Phase II studies rose from 237 to 464. Nearly double the submissions. No surrender flag flying here. So the pharma industry has been working overtime. How is the industry getting the work done? Outsourcing is a big part of it. We know many sponsor companies turn to CROs for the heavy lifting of their clinical development programs. Finding the service provider best suited to meet trial needs and ensuring that provider can meet performance expectations constitutes the onerous and time-intensive decision-making process that companies take on if they need to outsource any or all components of their clinical trials. In other words, companies need a reliable resource to shed light on CRO selection and CRO performance. This report is that resource. We aim to alleviate some of the stress associated with this process by enhancing your ability to make informed decisions. This year’s report includes insights from 237 experienced Phase II/III outsourcers and more than 800 service provider encounters. To participate in the study, it was a requirement for respondents’ companies to outsource Phase II/III clinical trials. What does the outsourcing community consider when it comes to CRO selection? We analyze a variety of factors, including an in-depth look at the prevalence of preferred provider agreements (PPAs). Different attributes drive provider selection depending on whether a company has a preferred list, deviates from their preferred list, or has no preferred list. This year, respondents deemed Operational excellence as the top attribute of importance across all scenarios. For those without a preferred list, however, Prior positive experience with service provider was nearly as important. A full comparison of shared versus scenario-specific attributes can be found in the first section of this report. Dimensions of Leadership, Familiarity, and Use also reveal a wealth of information including industry leaders and those vying to break into the higher tier. Additionally, we explore which providers are favored by respondents and where providers fall regarding cost perceptions. Collectively, these measures and more help to frame all that goes into CRO selection. Finding the best performing provider for your needs is the other piece to this puzzle. CRO performance evaluation makes up the bulk of this report and rightly so. Thirty-six provider drilldowns are provided, covering performance on 21 attributes across four categories (Budget Factors, Delivery Factors, Staff Characteristics, and Services). In addition, providers with at least 10 respondent evaluations are showcased in what we call profile pages. These pages are market research gold – they give a sense of a provider’s brand positioning, customer loyalty, and attribute-specific strengths and weaknesses. All drilldowns also include customer loyalty scores and respondent comments that further shed light on users’ experiences. One user had this to say for his reason for giving a provider satisfaction rating of 8 on a scale of 1 to 10: “Very successful cooperation in a broad Phase 3 program, led to successful license of a biological. No unexpected change orders, and very consistent core study team.” For sponsor companies, comments like this one may help put a provider on the short list to explore further. For the CRO, we can’t think of a better way to learn how their company is actually performing. We’re in the business of providing quality market research to ensure both sponsors and providers can glean what they need to make the best decisions possible for their clinical development programs and service offerings. If we’ve missed the mark in any way, do let us know. Welcome to the 13th edition of ISR’s Phase II/III CRO Benchmarking (13th Edition) report. ISRreports.com ©2021 2
Phase II/III CRO Benchmarking (13th Edition)
Methodology
237 respondents from
Data collected in Q4, 2020 North America, Europe,
and Asia
30-minute web-based
quantitative survey 829 service encounters were captured
ISRreports.com ©2021 3Phase II/III CRO Benchmarking (13th Edition)
Participant Criteria
Respondents were required to pass several screening criteria to qualify and participate in this survey:
• Must work at a pharmaceutical company, biotech company, or medical device company
• Must have responsibility in at least one of several relevant areas such as Clinical Operations, Project Management, Executive Management, or Research and Development Management
• Must have involvement with outsourced Phase II/III trials within past 12 months
ISRreports.com ©2021 4Phase II/III CRO Benchmarking (13th Edition)
Number of Ratings per Company
Service Provider Respondent Ratings Service Provider Respondent Ratings
Advanced Clinical 5 MMS Holdings 2
Bioclinica 21 NAMSA 2
Clinical Research Services (CRS) 2 Navitas Life Sciences 2
Clinipace 8 Novotech 9
Clintec 4 Ora 4
Covance 95 Parexel 105
CTI Clinical Trial & Consulting 7 Pharm-Olam International 10
DaVita Clinical Research 3 PharPoint 4
DCRI-Duke 8 PPD 84
Eurofins 23 PRA 55
Frontage 6 Premier Research 9
George Clinical 5 PSI 9
ICON 88 QPS 5
Innovaderm 3 Rho 7
IQVIA 113 SGS Life Sciences 9
Linical Accelovance 2 Syneos Health 63
Medpace 27 Synteract 12
Medsource 4 Worldwide Clinical Trials 14
Total Ratings 829
Companies listed in bold print have been reviewed by 10 or more respondents. These providers have detailed company service quality profiles and are included in an in-depth performance analysis.
ISRreports.com ©2021 5Service Provider Performance and Loyalty
Phase II/III CRO Benchmarking (13th Edition)
Primary Section Takeaways
1. Top Performers:
• Overall: Worldwide Clinical Trials, Medpace, Eurofins
• Budget Factors: Worldwide Clinical Trials, Medpace, Eurofins
• Delivery Factors: Worldwide Clinical Trials, Bioclinica, Parexel
• Staff Characteristics: Worldwide Clinical Trials, Medpace, Parexel
• Services: Worldwide Clinical Trials, Eurofins, Medpace
2. Customer Loyalty:
• 2021 Top Performers: Parexel, Worldwide Clinical Trials, Covance
• 3-Year Rolling Average Top Performers: PSI, Novotech, Parexel
ISRreports.com ©2021 7Phase II/III CRO Benchmarking (13th Edition) Performance Across Service Providers The “cross-CRO” chart on the next page has been developed as a way for pharma companies and CROs to quickly gauge how CROs perform against their peers on a specific performance attribute. The metrics used in the following chart assign 3 points if respondents indicated the service provider greatly exceeded expectations, 1 point if they somewhat exceeded expectations, 0 points if they met expectations, -1 point if they somewhat missed expectations and -3 points if they greatly missed expectations. A service provider’s scores are included on the chart if 10 or more respondents evaluate its performance on that attribute. A note regarding the Services attributes: scores are only shown if at least 10 respondents have recent experience using the provider for a particular service. For example, Worldwide Clinical Trials only has a score for one of the five services (Monitoring). Though not every provider may offer each of these services, participants may rate the provider’s management (or perceived management) of these services. ISRreports.com ©2021 12
Phase II/III CRO Benchmarking (13th Edition)
Worldwide
Industry Clinical CRO CRO CRO CRO CRO CRO CRO CRO CRO CRO CRO CRO
Average Trials A B C D E F G H I J K L
Appropriateness of change orders -0.11 0.21 0.17 -0.21 -0.14 -0.15 -0.11 0.00 -0.19 -0.15 -0.18 -0.07 0.00 -0.40
Cost -0.11 0.29 -0.09 -0.21 0.05 -0.03 -0.16 0.11 -0.27 -0.15 -0.24 -0.05 -0.08 0.10
Data quality 0.12 0.43 0.17 0.15 0.10 0.17 -0.10 0.11 0.10 0.12 0.04 0.17 0.00 -0.50
Easy to work with 0.07 0.57 0.09 -0.17 0.10 0.05 0.14 0.15 -0.08 0.10 0.02 0.09 0.17 -0.50
Local market/Regulatory knowledge 0.14 0.14 0.09 0.25 0.05 0.11 0.08 0.07 0.17 0.14 0.05 0.09 -0.08 -0.20
Meeting overall project timelines -0.01 0.00 0.04 -0.09 0.10 0.00 0.02 0.19 -0.10 -0.04 0.02 0.03 -0.17 -0.60
Operational excellence 0.01 0.36 -0.09 -0.01 0.05 -0.07 0.06 0.04 -0.09 0.02 -0.11 0.12 -0.25 -0.70
Patient recruitment -0.06 0.29 0.04 -0.09 0.00 -0.14 -0.11 0.00 -0.05 -0.02 -0.22 0.01 -0.33 -0.80
Speed of site start-up -0.13 -0.07 -0.13 -0.11 0.10 -0.17 -0.24 -0.07 -0.07 -0.12 -0.31 -0.13 -0.17 -0.90
Technology for real-time access to data 0.07 0.29 -0.09 0.06 0.05 0.18 -0.10 0.00 0.22 0.10 -0.02 0.13 -0.25 -0.60
Project manager quality 0.13 0.43 -0.09 0.03 -0.05 0.13 0.08 0.07 0.10 0.15 0.05 0.19 -0.25 -0.30
Responsiveness 0.10 0.50 0.04 -0.11 0.00 0.06 0.19 0.22 0.04 0.02 0.11 0.10 -0.25 0.00
Staff turnover -0.23 -0.36 0.04 -0.37 -0.29 -0.24 -0.46 0.15 -0.33 -0.24 -0.22 -0.23 -1.17 -0.40
Study design expertise 0.09 0.29 0.30 0.09 0.00 -0.01 0.13 0.30 0.12 0.04 -0.11 0.19 -0.25 -0.40
Therapeutic expertise 0.11 0.21 0.17 0.18 0.19 0.02 0.14 0.22 0.07 0.10 -0.13 0.14 -0.17 -0.40
Timely project communications 0.06 0.29 0.00 -0.03 0.19 0.07 0.11 0.22 0.00 -0.02 0.02 0.10 0.08 0.00
NOT NOT NOT
Central lab 0.16 ENOUGH
DATA
0.35 0.18 0.15 0.05 -0.10 0.50 0.10 0.22 0.07 0.25 ENOUGH
DATA
ENOUGH
DATA
NOT NOT NOT NOT NOT
Biostatistics 0.15 ENOUGH
DATA
ENOUGH
DATA
0.14 ENOUGH
DATA
0.14 -0.10 0.33 0.24 0.00 0.18 0.09 ENOUGH
DATA
ENOUGH
DATA
NOT NOT NOT
Data management 0.13 ENOUGH
DATA
0.27 0.09 0.25 0.13 0.00 0.15 0.16 0.16 0.09 0.12 ENOUGH
DATA
ENOUGH
DATA
NOT NOT NOT NOT
Monitoring 0.07 0.60 ENOUGH
DATA
-0.06 ENOUGH
DATA
-0.06 -0.04 0.20 0.04 0.13 0.05 0.10 ENOUGH
DATA
ENOUGH
DATA
NOT NOT NOT NOT NOT
Investigator recruitment 0.10 ENOUGH
DATA
ENOUGH
DATA
0.18 ENOUGH
DATA
0.02 -0.06 0.06 0.11 0.04 -0.10 0.19 ENOUGH
DATA
ENOUGH
DATA
ISRreports.com ©2021 13Phase II/III CRO Benchmarking (13th Edition)
Figure 1 - Budget Factors
Appropriateness
of change orders Cost
Worldwide Clinical Trials
CRO A
CRO B
CRO C
CRO D
CRO E
CRO F
CRO G
CRO H
CRO I
CRO J
CRO K
CRO L
Ratings Key
Outperforms competitors Average Underperforms competitors
Scores are in relation to the average, and do not necessarily indicate poor or problem-free performance.
Appropriateness
ISRreports.com ©2021 of change orders Cost 14Phase II/III CRO Benchmarking (13th Edition)
Figure 2 - Delivery Factors
Local market/ Meeting Technology for
Data Easy to Regulatory overall project Operational Patient Speed of site real-time
quality work with knowledge timelines excellence recruitment start-up access to data
Worldwide Clinical Trials
CRO A
CRO B
CRO C
CRO D
CRO E
CRO F
CRO G
CRO H
CRO I
CRO J
CRO K
CRO L
Ratings Key
Outperforms competitors Average Underperforms competitors
Scores are in relation to the average, and do not necessarily indicate poor or problem-free performance.
Local market/ Meeting Technology for
Data Easy to Regulatory overall project Operational Patient Speed of site real-time
ISRreports.com ©2021 quality work with knowledge timelines excellence recruitment start-up access to data 15Phase II/III CRO Benchmarking (13th Edition)
Figure 3 - Staff Characteristics
Project Study Timely
manager Staff design Therapeutic project
quality Responsiveness turnover expertise expertise communications
Worldwide Clinical Trials
CRO A
CRO B
CRO C
CRO D
CRO E
CRO F
CRO G
CRO H
CRO I
CRO J
CRO K
CRO L
Ratings Key
Outperforms competitors Average Underperforms competitors
Scores are in relation to the average, and do not necessarily indicate poor or problem-free performance.
ISRreports.com ©2021 16About Industry Standard Research Industry Standard Research 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 website at ISRreports.com, email info@ISRreports.com, or follow us on Twitter @ISRreports. Send Us Your Feedback Because we are a service organization, we enjoy receiving feedback on our work. Please e-mail any comments, questions, or suggestions to info@ISRreports.com. Copyright 2021 Industry Standard Research. All rights reserved. “Act with confidence”, ISR Reports and Industry Standard Research are trademarks of Industry Standard Research. All other trademarks are property of their respective holders. Information is subject to change since Industry Standard Research reserves the right to make changes without notice. While the information contained herein has been prepared from sources deemed to be reliable, Industry Standard Research reserves the right to revise the information without notice but has no obligation to do so. Use of this information is at your sole discretion. For more information, contact Industry Standard Research at 1-919-301-0106. Printed in the USA April, 2021.
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