PDF An Excerpt From the 2019 Cro Leadership Awards Issue

[Pages:12]SELECTING CROs

AN EXCERPT FROM THE 2019 CRO LEADERSHIP AWARDS ISSUE

research OUTSOURCING

INFLUENCE OF SIZE IN CRO SELECTION By R. McAvoy

Influence Of Size In CRO Selection

REBECCA MCAVOY

C RO selection. Whether you've been in the business of clinical trials for two years or 20, this process often remains onerous, time-consuming, challenging, crucial, drawn out, stressful ... need I go on?

It may seem as though there are countless factors to consider when selecting a CRO. Don't get me wrong; there certainly is a lot to consider. For that reason, ISR provides data that can be used to prioritize what is important in the provider selection process. We surveyed hundreds of clinical development outsourcers about what they consider important when selecting providers. To capture the increasing role that preferred provider agreements are playing in the selec-

tion process, respondents were asked about attribute importance in several scenarios: 1) choosing among preferred providers, 2) choosing a provider not on their preferred list, and 3) choosing a provider in the absence of a preferred list.

Capturing these nuances affords those working at sponsor organizations the opportunity to directly apply attribute-importance data from the appropriate decision-making scenario to the selection qualifications employed at their companies. Those from CROs can use the information to walk into a bid defense in any of the decision-making scenarios armed with a solid sense of what the industry feels is important when selecting a provider in that situation.

FIGURE 1

9%

Strongly agree Slightly disagree

Moderately agree Moderately disagree

Slightly agree Strongly disagree

"Small/niche providers that specialize in only a few therapeutic areas offer a higher level of therapeutic expertise than CROs"

30%

37%

18%

5% 2%

"Some CROs are just too large"

22%

25%

28%

14%

9% 3%

5% 11%

"My organization will decrease the proportion of outsourced spend going to large, global CROs over the next two years"

29%

30%

15%

0%

20%

40%

60%

% of Respondents

SOURCE: Industry Standard Research, CRO Quality Benchmarking Report Suite (11th Edition)

80%

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THE CRO LEADERSHIP AWARDS 2019



10% 100%

PROVIDER SIZE & THE EFFECT ON THERAPEUTIC EXPERTISE Therapeutic expertise has remained among the most important attributes from year to year, across trial phases, regardless of whether there are preferred provider agreements in place. An organization's therapeutic expertise (or lack thereof) is often commented upon when respondents explain their reasoning for assigning overall satisfaction scores for CROs they have recently used. In short, a provider's knowledge of the desired therapeutic areas and its prior experience working in these areas go a long way in determining whether a provider is chosen for a clinical study.

Where does CRO size come into play? Size undoubtedly is a factor in an organization's ability to deliver global studies or offer a one-stop-shop experience. But how does provider size affect customers' perceptions of therapeutic expertise? Over the last decade of researching service provider selection, ISR often has seen outsourcers attributing smaller CROs with superior therapeutic expertise in their areas of specialty compared to large CROs, and we wanted to gather the opinions of a larger group. We asked over 500 clinical development outsourcers about their levels of agreement with the statement: Small/niche providers that specialize in only a few therapeutic areas offer a higher level of therapeutic expertise than large CROs (figure 1).

Turns out, about three-quarters of respondents agreed with this statement. About 40 percent indicate that their agreement is moderate to strong. Unquestionably, there are many other factors that go into the decision of which CRO will shepherd a molecule through critical clinical trials -- geographic footprint, service capabilities, project manager quality, patient recruitment abilities, and cost, just to name a few. However, the perception that small/niche providers have better therapeutic expertise than their larger counterparts is an interesting one. Small organizations can tout their deep therapeutic expertise in specific areas in marketing messaging, and this data shows that audiences are likely to find these claims credible. Large CROs may do well to message around their therapeutic expertise as well -- perhaps along the lines of "Our therapeutic breadth doesn't come at the expense of depth."

Respondents were also asked to rate their agreement with the statement: Some CROS are just too large (figure 1). Again, three-quarters of respondents agreed that some CROs are just too large. And, again, this is a sentiment seen in open-ended responses over the years, often referencing cumbersome processes and poor communication in larger CROs.

The following quotes are from 2018 and 2019 studies regarding reasoning for recent user satisfaction

ratings for large CROs: "[Large provider is] too big of an organization to get anything effectively done." "Their way of working, due to [being a] big organization, is sometimes lagging when rapid decisions [are] required." "They are becoming too large of a CRO." "Too big [of a] CRO for Phase 1." "Sometimes it feels too big to be as responsive as needed." "Too large [of an] organization, bureaucracy overload."

WHAT'S NEXT? So where does all this leave us? ISR asked respondents to rate their agreement with a third statement regarding CRO size: My organization will decrease the proportion of outsourced spend going to large, global CROs over the next two years (figure 1). In this case, responses were more split. Nearly half (45 percent) agreed that they would decrease the proportion of spend going to large CROs over the coming two years.

Although respondents didn't have a unified voice about their companies' expected future usage of large CROs, this is a statistic to take note of. If nearly half of outsourcers expect usage of large CROs to decline, this spells opportunity for smaller CROs, which should consider heralding their small size and deep therapeutic expertise as benefits. Large CROs may want to consider proactively marketing around attributes traditionally considered strengths of smaller CROs, such as flexibility. L

REBECCA MCAVOY is VP of market research at Industry Standard Research.

Survey Methodology: Industry Standard Research is a full-service market research provider to the pharma and pharma services industries. ISR's CRO Quality Benchmarking research is conducted annually via an online survey. For the 2019 CRO Awards data, more than 60 service providers were evaluated on over 20 different performance metrics. Research participants were recruited from biopharmaceutical and medical device companies of all sizes and are screened for decision-making influence and authority when it comes to working with CROs. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that quality ratings come from actual involvement with a business and that companies identified as leaders are backed by experiential data.



THE CRO LEADERSHIP AWARDS 2019

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2019 CRO LEADERSHIP AWARDS

2019 CRO LEADERSHIP AWARDS WINNERS

Life Science Leader's readership of pharmaceutical and biopharmaceutical executives have told us about their struggles in efficiently vetting potential CRO partners. In response to this input, Life Science Leader developed the CRO Leadership Awards.

Based on research from Industry Standard Research's Contract Research Organization Quality Benchmarking annual online survey, more than 60 contract research organizations were evaluated on more than 20 different performance metrics. Research participants were recruited from biopharmaceutical companies of all sizes and were screened for decision-making influence and authority when it comes to working with contract research organizations. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that quality ratings come from actual involvement with a business and that companies identified as leaders are backed by experiential data. CROs have an opportunity to win these awards in up to three groups of outsourcing respondents -- Big Pharma, Small Pharma, and Overall (combined Big and Small Pharma).

WHAT ARE THE AWARDS? ISR survey participants were asked to provide an expectation rating for each CRO they have worked with in the past 18 months. Points were then totaled for a combined score for each attribute and a composite score for each core category was determined. Winning CROs were determined when comparing their overall score vs. the competitive set.

To learn more about ISR's industry reports, customized research, or to be included in future CRO Quality Benchmarking annual surveys, visit or contact ISR at info@.

PRESENTED BY:

RESEARCH CONDUCTED BY:

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THE CRO LEADERSHIP AWARDS 2019



CAPABILITIES

TOP PERFORMERS

OVERALL

SGS Novotech PSI CRO CRS Clinical Research Services

Andernach GmbH Celerion BioPharma Services Inc. Altasciences

BIG PHARMA

SGS CTI Clinical Trial & Consulting Novotech Ora

SMALL PHARMA

Novotech US Oncology PSI CRO Celerion Medpace Worldwide Clinical Trials

All facilities fully owned Complementary core competencies to in-house

or other manufacturing contractors Facility has most up-to-date manufacturing technologies Full range of manufacturing for the dosage forms we

require Has capacity to meet our demands Offers innovative solutions Proven ability to manufacture API Provides regulatory support for filing Stability testing capabilities; storage capabilities

EXCEEDED CUSTOMER EXPECTATIONS

OVERALL

US Oncology Worldwide Clinical Trials Medpace CTI Clinical Trial & Consulting Eurofins Scientific, S.E. PRA Health Sciences Duke Clinical Research Institute PAREXEL Frontage Laboratories DaVita Clinical Research Novum Pharmaceutical

Research Services Ora

BIG PHARMA

Lambda DaVita Clinical Research PRA Health Sciences Bioclinica Covance Duke Clinical Research Institute PPD

SMALL PHARMA

Eurofins Scientific, S.E. Altasciences PAREXEL Duke Clinical Research Institute Frontage Laboratories PRA Health Sciences NAMSA Rho

MET CUSTOMER EXPECTATIONS

OVERALL

Covance PPD ICON Plc Bioclinica MedSource IQVIA

BIG PHARMA

PAREXEL WCCT Global IQVIA ICON Plc Syneos Health

SMALL PHARMA

ICON Plc QPS LLC

Companies are listed in ranking order per survey results. The terms "Small Pharma" and "Big Pharma" pertain to the outsourcing respondents, not the winners. "Overall" is a combination of Big and Small Pharma.



THE CRO LEADERSHIP AWARDS 2019

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2019 CRO LEADERSHIP AWARDS WINNERS

2019 CRO LEADERSHIP AWARDS

Access to desired markets Accessible senior management Complementary core competencies to in-house

or other manufacturing contractors Cultural fit Financial strength/stability Timely project communications Well-regarded within the industry

COMPATIBILITY

TOP PERFORMERS

OVERALL

Novotech BioPharma Services Inc. Celerion Altasciences Rho PSI CRO SGS CRS Clinical Research Services

Andernach GmbH Pharm-Olam, LLC Medpace Novum Pharmaceutical

Research Services Worldwide Clinical Trials

BIG PHARMA

CTI Clinical Trial & Consulting SGS Novotech Bioclinica Ora

SMALL PHARMA

Novotech Celerion Rho Altasciences Medpace PSI CRO Worldwide Clinical Trials Pharm-Olam, LLC

EXCEEDED CUSTOMER EXPECTATIONS

OVERALL

Ora Bioclinica US Oncology CTI Clinical Trial & Consulting PRA Health Sciences ICON Plc Eurofins Scientific, S.E. Duke Clinical Research Institute

BIG PHARMA

Syneos Health ICON Plc WCCT Global PPD PRA Health Sciences Lambda

SMALL PHARMA

US Oncology Duke Clinical Research Institute Frontage Laboratories DaVita Clinical Research PRA Health Sciences Eurofins Scientific, S.E. ICON Plc Ora PAREXEL NAMSA

MET CUSTOMER EXPECTATIONS

OVERALL

Frontage Laboratories PAREXEL Syneos Health SynteractHCR PPD MedSource DaVita Clinical Research Covance QPS LLC Clinipace

BIG PHARMA

Covance PAREXEL Eurofins Scientific, S.E. Duke Clinical Research Institute IQVIA

SMALL PHARMA

SynteractHCR QPS LLC PPD Bioclinica Syneos Health

Companies are listed in ranking order per survey results. The terms "Small Pharma" and "Big Pharma" pertain to the outsourcing respondents, not the winners. "Overall" is a combination of Big and Small Pharma.

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THE CRO LEADERSHIP AWARDS 2018



 Ability to smoothly scale up manufacturing and transfer technology

Experience level of staff Offers innovative solutions Provides regulatory support for filing Scientific knowledge Strong regulatory track record

EXPERTISE

TOP PERFORMERS

OVERALL

US Oncology Novotech BioPharma Services Inc. Ora Altasciences SGS PSI CRO

BIG PHARMA

CTI Clinical Trial & Consulting SGS Lambda Novotech Bioclinica Ora

SMALL PHARMA

US Oncology Ora Novotech PSI CRO

EXCEEDED CUSTOMER EXPECTATIONS

OVERALL

Duke Clinical Research Institute Medpace Rho Covance PAREXEL Novum Pharmaceutical

Research Services Lambda Celerion Bioclinica CTI Clinical Trial & Consulting Worldwide Clinical Trials

BIG PHARMA

Duke Clinical Research Institute Covance IQVIA PPD

SMALL PHARMA

Altasciences Medpace Rho PAREXEL Worldwide Clinical Trials Celerion Eurofins Scientific, S.E. PRA Health Sciences ICON Plc Covance Duke Clinical Research Institute

MET CUSTOMER EXPECTATIONS

OVERALL

ICON Plc PPD Eurofins Scientific, S.E. CRS Clinical Research Services

Andernach GmbH MedSource IQVIA Pharm-Olam, LLC PRA Health Sciences WCCT Global DaVita Clinical Research Syneos Health

BIG PHARMA

DaVita Clinical Research ICON Plc PAREXEL Syneos Health Medpace WCCT Global

SMALL PHARMA

PPD Pharm-Olam, LLC NAMSA QPS LLC Bioclinica



THE CMO LEADERSHIP AWARDS 2019

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2019 CRO LEADERSHIP AWARDS WINNERS

2019 CRO LEADERSHIP AWARDS

All facilities fully owned Financial strength/stability Flexibility to adjust schedule for special requests Has capacity to meet our demands Reliable on-time delivery Timely project management Up-front contingency planning, risk management

QUALITY

TOP PERFORMERS

OVERALL

Novotech PSI CRO BioPharma Services Inc. Rho SGS CRS Clinical Research Services

Andernach GmbH Celerion

BIG PHARMA

SGS Novotech Ora CTI Clinical Trial & Consulting Lambda

SMALL PHARMA

Novotech Rho PSI CRO Altasciences Celerion Medpace

EXCEEDED CUSTOMER EXPECTATIONS

OVERALL

Altasciences MedSource Ora CTI Clinical Trial & Consulting Medpace Pharm-Olam, LLC PAREXEL ICON Plc Novum Pharmaceutical

Research Services Eurofins Scientific, S.E. US Oncology

BIG PHARMA

Covance Bioclinica WCCT Global PAREXEL ICON Plc

SMALL PHARMA

Eurofins Scientific, S.E. NAMSA Worldwide Clinical Trials Pharm-Olam, LLC ICON Plc PAREXEL Ora US Oncology PRA Health Sciences

MET CUSTOMER EXPECTATIONS

OVERALL

Covance Worldwide Clinical Trials Bioclinica Duke Clinical Research Institute PRA Health Sciences WCCT Global PPD Lambda IQVIA

BIG PHARMA

PPD Duke Clinical Research Institute Syneos Health DaVita Clinical Research IQVIA

SMALL PHARMA

QPS LLC SynteractHCR Bioclinica Frontage Laboratories

Companies are listed in ranking order per survey results. The terms "Small Pharma" and "Big Pharma" pertain to the outsourcing respondents, not the winners. "Overall" is a combination of Big and Small Pharma.

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THE CRO LEADERSHIP AWARDS 2019



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