Clinical Imaging: Market and

Outsourcing Dynamics

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Report OverviewClinical imaging has become an integral part of the extensive and expensive research and development process of the pharmaceutical and biotechnology industries. Clinical imaging modalities such as magnetic resonance images (MRI), computed topography scans (CT), and x-rays are fundamental in testing the safety and efficacy of drugs in development phases I through IV.

This report offers two unique perspectives to the clinical imaging service provider market based on the surveys ISR has administered – one from the perspective of companies who currently outsource their imaging services and another from the actual imaging service providers.

7,906Clinical Imaging Trials Analyzed

134Pages

26Companies Included 1. Executive summary

2. Demographics & responsibilities of companies outsourcing imaging services

3. Perspectives on outsourcing from companies that outsource imaging services

4. Experiences & practices of companies outsourcing imaging services

5. Current use of imaging within clinical trials

6. Service provider capabilities

Methodologies

How you can use this report:

Report Structure:

Sponsor Companies:

• Compare potential service providers • Identify which imaging companies are most

recognizable in the imaging service sector• Learn how competitors use imaging service

providers

Imaging Companies:

• Understand the needs and demands that currently exist within the market

• Benchmark current offerings compared to industry averages

• Learn how to differentiate from competitors

ISR gathered content for this report via an exhaustive primary and secondary research effort.

Primary Research:

• 30-45 minute web based quantitative and qualitative survey with 60 respondents from companies who outsource imaging clinical trials

• Company profile questionnaires distributed to CROs profiled in this report

Secondary Research:

• An analysis of clinicaltrials.gov data to provide a high-level overview of current clinical imaging trial activity

• Company and Association information gathered from company websites and publications

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Full-service CROs• Bioclinica• Biomedical Systems• Certus International• Charles River• Covance• ICON• Medpace• PAREXEL Informatics• QPS Holdings, LLC• Caliper Discovery Alliances and Services

Dedicated imaging CROs• Canfield Scientific, Inc• Cardiovascular Imaging Technologies• Clinical Image Management Systems• Flagship BioSciences• ACR Image Metrix• Illuminostics• Imaging Endpoints• Inference Systems• Intrinsic Imaging• Molecular NeuroImaging• Numira Biosciences• Prism Clinical• Radcore Labs• Radiant Sage• VirtualScopic• WorldCare

MRI

PET

Angiograph

ECHO

Tomograph

Ultrasound

SPECT

X-ray

Companies Included:

Imaging Modalities Included:

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Table of ContentsCopyright and usage guidelines

Introduction

Report benefits

Report sections

Methodology and sources

Executive Summary

Imaging provider characteristics

Differentiating imaging-dedicated and full-service CROs

Trends amongst companies that outsource imaging services

Overview of imaging service provider capabilities

Overview of company profile results

ClinicalTrials.gov summary data

Demographics & responsibilities of respondents outsourcing imaging services

Respondent demographics

Type of organization

Job titles of respondents

Corporate headquarters location

Office location

Functional areas of responsibility

Primary functional responsibility

Respondent roles in selecting outsourcing vendors

Perspectives on outsourcing imaging services

Use of imaging modalities

Imaging modalities used in past 12 months

Growth/decline in use of imaging modalities

How imaging is utilized

Imaging needs met by clinical vs. molecular imaging

Anticipated imaging needs met by clinical vs. molecular imaging

Centralized vs. decentralized approach to image reading

Preference for centralized vs. decentralized approach to image reading

Perceived value of imaging service providers

Projected growth/decline in imaging studies – 18 month projection

Experiences & practices of companies outsourcing imaging services

Familiarity with imaging service providers

Level of involvement with imaging trials

Familiarity with imaging service providers

Familiarity with specific imaging service providers

Preferred attributes of imaging service providers

Top 5 attributes of imaging service providers – selected by those outsourcing the service

Top 3 attributes of imaging service providers – selected by those outsourcing the service

Top attribute of imaging service providers – selected by those outsourcing the service

Imaging outsourcing market

Likelihood to outsource specific imaging services

Percent of imaging services that are outsourced

Percent of imaging services to be outsourced – 18 month projection

Current use of imaging within clinical trials

All technologies

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials by phase

Average number of patients in clinical imaging trials by phase - industry only

Clinical imaging trails by sponsor company

Clinical imaging trials by sponsor type

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

MRI

Number of clinical imaging trials by phase

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Table of ContentsNumber of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials by phase

Average number of patients in clinical imaging trials by phase – industry only

MRI clinical imaging trails by sponsor company

Clinical imaging trials by sponsor type

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

PET

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials by phase

Average number of patients in clinical imaging trials by phase – industry only

PET clinical imaging trials by sponsor company

Clinical imaging trials by sponsor type

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

Angiograph

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials by phase

Average number of patients in clinical imaging trials by phase - industry only

Angiograph clinical imaging trails by sponsor company

Clinical imaging trials by sponsor type

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase– industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

ECHO

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials by phase

Average number of patients in clinical imaging trials by phase – industry only

ECHO clinical imaging trials by sponsor company

Clinical imaging trials by sponsor type

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

Tomograph

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials

Average number of patients in clinical imaging trials by phase – industry only

Tomograph clinical imaging trails by sponsor company

Clinical imaging trails by sponsor type

Number of interventional imaging trials by phase

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Table of Contents

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

Ultrasound

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials by phase

Average number of patients in clinical imaging trials by phase– industry only

Ultrasound clinical imaging trails by sponsor company

Clinical imaging trials by sponsor type

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

X-ray

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patient in clinical imaging trials by phase

Average number of patient in clinical imaging trials by phase – industry only

X-ray clinical imaging trails by sponsor company

Clinical imaging trials by sponsor type

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

SPECT

Number of clinical imaging trials by phase

Number of clinical imaging trials by phase – industry only

Average number of patients in clinical imaging trials by phase

Average number of patients in clinical imaging trials by phase – industry only

Clinical imaging trials by sponsor type

SPECT clinical imaging trails by sponsor company

Number of interventional imaging trials by phase

Number of interventional imaging trials by phase – industry only

Average number of patients in interventional imaging trials by phase

Average number of patients in interventional imaging trials by phase – industry only

Service provider capabilities

Capabilities charts

Company Profiles

Company profiles - Dedicated Imaging CROs

Intrinsic Imaging

Radiant Sage

Contact list – Dedicated Imaging CROs

Company profiles - Full-Service CROs

Bioclinica

Biomedical Systems

Medpace

Contact list – Full-Service CROs

About Industry Standard Research

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Introduction

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IntroductionClinical imaging has become an integral part of the extensive and expensive research and development process of the pharmaceutical and biotechnology industries� Clinical imaging modalities such as magnetic resonance images (MRI), computed topography scans (CT), and x-rays are fundamental in testing the safety and efficacy of drugs in development phases I through IV� As is the case with controlled, interventional study designs, the volume of scans that must be done for statistically significant results that successfully eliminate the incidence of type I and type II errors is substantial�

Further, because these scans offer little (if any) quantitative information, reading the data offered by imaging software often requires professionals with backgrounds in radiology� Coupled with equipment and labor costs, the cost of clinical imaging becomes a major factor in the drug development process that requires informed decision-making by both pharmaceutical companies and CROs that outsource or perform their imaging processes�

ISR has identified two types of clinical imaging service providers that are outlined and compared to one another throughout this report� The imaging needs of a company may depend on whether a company requires an imaging service in addition to other clinical research services or would prefer working with a company that focuses exclusively on imaging modalities� ISR will use “multi-service CROs” and “dedicated imaging CROs” to differentiate the two�

• Multi-service CROs: Larger CROs such as ICON have developed imaging departmentswith extensive databases of clinical imaging outputs to augment their full-servicecapabilities�

• Dedicated imaging CROs: Service providers such as ACR Image Metrix focus exclusivelyon imaging services and operate as a vendor to not only pharmaceutical companies, butother CROs in need of imaging services�

Recent industry activity

• July 2013: VirtualScopics, a full-service CRO completed a Phase III breast cancer studywhich included ten thousand image scans and two million data records in five weeks’time with no data errors�

• March 2013: Private equity firm, JLL Partners acquired BioClinica and CoreLab in aneffort to establish an industry model for imaging core lab services� The point being,clinical imaging services are growing within the industry and third party companies aretaking notice�

• March 2012: WorldCare Clinical began offering a 24-hour safety assessment service forclinical images via their WorldPro automated image management platform�

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Perspectives on outsourcing imaging services

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Perceived value of imaging service providers“I view imaging service providers I work with as…” (Base=60)

Projected growth/decline in imaging studies – 18 month projection“Over the next 18 months, how do you expect the volume of imaging studies to change? Your best estimate is fine.” (Base=60)

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Perceived value of imaging service providers

“I view imaging service providers I work with as…” (Base=60)

Projected growth/decline in imaging studies – 18 month projection

“Over the next 18 months, how do you expect the volume of imaging studies to change? Your best estimate is fine.” (Base=60)

10%

48%

42%

0% 10% 20% 30% 40% 50% 60%

Low value-add vendors

Incremental value-add suppliers

High value-add partners

2%

2%

3%

3%

33%

30%

23%

3%

0% 5% 10% 15% 20% 25% 30% 35%

Don’t know

Greatly decrease (>-20%)

Moderately decrease (-10-20%)

Slightly decrease (-5-10%)

Remain roughly constant (+/- 5%)

Slightly increase (5-10%)

Moderately increase (10-20%)

Greatly increase (>20%)

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Perceived value of imaging service providers

“I view imaging service providers I work with as…” (Base=60)

Projected growth/decline in imaging studies – 18 month projection

“Over the next 18 months, how do you expect the volume of imaging studies to change? Your best estimate is fine.” (Base=60)

10%

48%

42%

0% 10% 20% 30% 40% 50% 60%

Low value-add vendors

Incremental value-add suppliers

High value-add partners

2%

2%

3%

3%

33%

30%

23%

3%

0% 5% 10% 15% 20% 25% 30% 35%

Don’t know

Greatly decrease (>-20%)

Moderately decrease (-10-20%)

Slightly decrease (-5-10%)

Remain roughly constant (+/- 5%)

Slightly increase (5-10%)

Moderately increase (10-20%)

Greatly increase (>20%)

© Industry Standard Research

© Industry Standard Research

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Perspectives on outsourcing imaging services

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Use of imaging modalitiesImaging modalities used in past 12 months“Which of the following imaging services have you used in the past 12 months? (Select all that apply)” (Base=60)

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Perspectives on outsourcing imaging services

Use of imaging modalit ies

Imaging modalit ies used in past 12 months

“Which of the following imaging services have you used in the past 12 months? (Select all that apply)” (Base=60)

0%

2%

3%

3%

5%

5%

8%

12%

12%

13%

15%

17%

17%

18%

18%

33%

42%

47%

48%

62%

72%

0% 10% 20% 30% 40% 50% 60% 70% 80%

Video gait analysis

Orthopantomography (OPT or OPG)

Actigraphy

Photoacoustic imaging

SPECT

Thermal

Autoradiography

Breast thermography

Radiography: Fluoroscopy and Projectional radiographs

Doppler

Diffusion tensor imaging (or Diffusion MRI)

Angiography

Dual energy x-ray absorptiometry (DEXA)

Functional magnetic resonance imaging (fMRI)

Photography

X-ray

Nuclear Medicine: Positron emission tomography (PET)

Ultrasound

Echocardiography (ECHO)

Computed tomography (CT)

Magnetic resonance imaging (MRI)

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Current use of imaging within clinical trials

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Average number of patients in clinical imaging trials by phaseResults are based on the number of trials (N=7,906) reported by clinicaltrials�gov to contain one of the imaging modalities (or variations of that imaging modality) in the trial’s description� The chart reports the average number of patients participating in clinical trials by phase (as well as the total number of that phase’s trials taking place)� How to read chart: “In 2010, for the 193 phase I imaging trials that took place, there was an average of 40 patients participating in each trial�”

2010 2011 2012 2013 Total

Phase 0 1967 (N=19)

29 (N=16)

54 (N=41)

86 (N=19)

451 (N=95)

Phase I 40 (N=193)

43 (N=188)

47 (N=171)

38 (N=68)

42 (N=620)

Phase II 75 (N=444)

87 (N=355)

89 (N=395)

80 (N=219)

83 (N=1413)

Phase III 755 (N=192)

507 (N=201)

1050 (N=181)

296 (N=84)

703 (N=658)

Phase IV 339 (N=217)

458 (N=217)

327 (N=234)

219 (N=76)

358 (N=744)

No Phase 3315 (N=1088)

*516 (N=1141)

4422 (N=1361)

3643 (N=786)

*603(N=4376)

Total 1811 (N=2153)

*391(N=2118)

2656 (N=2383)

2324 (N=1252)

*449(N=7906)

*ISR believes the enrollment figure for the trials taking place in 2011 and subsequently under the total column with “no Phase” listed were heavily influenced by an outlier which was removed�

All Technologies

© Industry Standard Research

Sample Page

2010 2011 2012 2013 Total

Phase 0 1967 (N=19)

Phase I 40 (N=193)

Phase II 75 (N=444)

Phase III 755 (N=192)

Phase IV 339 (N=217)

No Phase 3315 (N=1088)

Total 1811 (N=2153)

Data available in full report

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