Cardiac Monitoring: Market and Outsourcing Dynamics. October, 2014

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1 Cardiac Monitoring: Market and Outsourcing Dynamics October, 2014

2 Introduction act with confidence Table of Contents Copyright and usage guidelines... 4 Introduction...5 Differentiating dedicated cardiac monitoring and full-service CROs...6 Report benefits...7 Report sections...8 Methodology and sources...9 Executive summary...10 Business dynamics Cardiac monitoring services: Current use and expected growth Preference for centralized vs. decentralized approach to reading tests...12 Cardiac monitoring service provider dynamics...13 Provider familiarity...14 Top attributes of cardiac monitoring service providers selected by those outsourcing the service...15 Likelihood to outsource specific cardiac monitoring services...16 Overview of cardiac monitoring service provider capabilities...17 Overview of company profile results...18 Study data...19 Demographics & responsibilities of respondents outsourcing cardiac monitoring activities Type of organization Job titles of respondents...21 Corporate headquarters/office location...21 Functional areas of responsibility Level of involvement with cardiac monitoring trials Familiarity with general cardiac monitoring products and services Cardiac monitoring services Cardiac monitoring services used in past 12 months Growth/decline in use of cardiac monitoring services Perspectives on outsourcing from companies that outsource cardiac monitoring activities Perceived value of cardiac monitoring service providers Service provider familiarity...27 Use of centralized vs. decentralized approach to reading tests Preference for centralized vs. decentralized approach to reading tests Projected growth/decline in cardiac monitoring studies 18 month projection Top attributes of cardiac monitoring service providers selected by those outsourcing cardiac monitoring activities Likelihood to outsource specific cardiac monitoring activities...31 Percent of cardiac monitoring activities that are outsourced Cardiac Monitoring: Market and Outsourcing Dynamics 2

3 Introduction act with confidence Percent of cardiac monitoring activities to be outsourced 18 month projection Current use of cardiac monitoring within clinical trials...34 Number of clinical cardiac monitoring trials by phase Number of cardiac monitoring trials by phase industry only Average number of patients in cardiac monitoring trials by phase...36 Average number of patients in cardiac monitoring trials by phase - industry only Average number of patients in interventional cardiac monitoring trials by phase Average number of patients in interventional cardiac monitoring trials by phase industry only...38 Cardiac monitoring trials by sponsor company...39 Cardiac monitoring trials by sponsor type...40 Number of interventional cardiac monitoring trials by phase...40 Number of interventional cardiac monitoring trials by phase industry only Service provider capabilities...42 Capabilities charts...43 Company profiles - Dedicated cardiac monitoring CROs BioClinica Cardiabase icardiac...56 Company profiles - Full-service CROs...60 Biomedical Systems...60 Quintiles...63 Spaulding Clinical...70 About Industry Standard Research Cardiac Monitoring: Market and Outsourcing Dynamics 3

4 Introduction act with confidence Thank you for your purchase of the Cardiac Monitoring: Market and Outsourcing Dynamics report. Please read and observe the following articles associated with the use and distribution of the contents of this report. The purchase of a Single User License means that the report, either in whole or in part, cannot be distributed by any means to individuals or organizations beyond the original purchaser of the license. If at any point you wish to convert your Single User License to an Enterprise-wide License, Industry Standard Research will gladly do so. The purchase of an Enterprise-wide License means that the report may be circulated, either electronically or via hardcopy, within but not beyond the company holding the Enterprise-wide License. Any license holder should feel free to include elements of this report in his or her own work products (i.e., reports and presentations), providing that the elements carry with them a citation stating: Source: Industry Standard Research, No advertising or other promotional use can be made of the information in this report without the express prior written consent of Industry Standard Research. For such consent, please contact Andrew Schafer, President, at (919) or via at AndrewS@ISRreports.com Cardiac Monitoring: Market and Outsourcing Dynamics 4

5 Introduction act with confidence Introduction The clinical development process is a multibillion dollar industry and cardiac monitoring tests are becoming an integral step towards a drug s eventual approval. There are a multitude of cardiac monitoring modalities and services each with its own related equipment and processes. Cardiac monitoring services are expensive due to the equipment needed to run the tests, the labor required to interpret the tests, and the infrastructure of the service provider that will allow such cardiac monitoring tests to be run. Cardiac monitoring is done for drugs across all therapeutic areas not just those relating to the heart and cardiovascular system. This being the case, companies offering ECG and cardiac monitoring services specialize in particular therapeutic areas as a way to differentiate themselves. Another means by which these companies differentiate themselves is by operating in particular phases of the clinical development process. Spaulding Clinical, for example, focuses on preclinical and Phase I, while larger companies like ICON operate in all phases of development. The major divide between the CROs that offer cardiac monitoring services is whether or not the company is a multi-service CRO with a division that specializes in cardiac monitoring or a company that exclusively operates as a cardiac monitoring provider. Multi-service CROs: Larger CROs such as ICON have developed in-house cardiac monitoring divisions to use in their own clinical trials as well as in trials from other CROs and pharmaceutical companies that have chosen to outsource this service to ICON. Dedicated cardiac monitoring providers: Providers such as Cardioanalytics focus exclusively on ECG and cardiac monitoring services and operate as a vendor to not only pharmaceutical companies, but CROs in need of cardiac monitoring services. ISR has identified companies in the cardiac monitoring space, thoroughly examined their service offerings through primary and secondary research, and provided the results in this report as an important step towards understanding the market and the players Cardiac Monitoring: Market and Outsourcing Dynamics 5

6 Introduction act with confidence Differentiating dedicated cardiac monitoring and full-service CROs Of the CROs included in this report, there are more full-service CROs that provide cardiac monitoring services than there are CROs entirely dedicated to cardiac monitoring services. While it is not a definitive indication that the majority of cardiac monitoring services come from full-service CROs, the major players like Quintiles, Covance, ICON, and PAREXEL all provide sophisticated cardiac monitoring services. The list of cardiac monitoring CROs in this report (listed below) is not meant to be an exhaustive list of cardiac monitoring providers. The CROs included in this report were found through ISR s secondary research efforts to provide cardiac monitoring services in the clinical trial space. Full-Service CROs Dedicated Cardiac Monitoring CROs 32% 68% Full-Service CROs BioClinica Biomedical Systems Celerion Clinilabs ERT ICON Integrium PAREXEL PPD Quintiles Seahorse Scientific Services SGS Life Sciences Spaulding Dedicated Cardiac Monitoring CROs Cardiabase CardioAnalytics Cardiocore CardioLabs icardiac Medicomp Cardiac Monitoring: Market and Outsourcing Dynamics 6

7 Introduction act with confidence Report benefits This report offers two unique perspectives to the cardiac monitoring service provider market based on the surveys ISR has administered one from the perspective of companies who currently outsource their cardiac monitoring activities and another from the actual cardiac monitoring service providers. Benefits to cardiac monitoring service providers: Offers those companies currently providing cardiac monitoring services an idea of what needs and demands currently exist within the market. Identifies which cardiac monitoring companies are most recognizable in the cardiac monitoring service sector. Provides cardiac monitoring service providers an idea of how their current offerings compare to their competitors. Benefits to companies outsourcing their cardiac monitoring activities: Provides companies that outsource their cardiac monitoring activities a way of comparing potential service providers. Identifies which vendors are being used most by their competitors. ISR also conducted a clinicaltrials.gov analysis that provides an even higher level overview of the current cardiac monitoring clinical trial space that can be used by both cardiac monitoring service providers and those companies outsourcing the service. For example, if both types of companies know that the average Phase III study involving cardiac monitoring had 493 participants in 2013, both the outsourcing company and cardiac monitoring service provider could better estimate costs associated with conducting or outsourcing such a trial Cardiac Monitoring: Market and Outsourcing Dynamics 7

8 Introduction act with confidence This report contains the following 6 major sections. The report contains an executive summary that ties all the data together to provide a high level overview and primary takeaways for the reader as well as six detailed sections of data. 1. Executive summary: The key findings of the report are addressed and accompanied by high level-takeaways, industry implications, and recommendations for outsourcing companies, cardiac monitoring service providers, and the clinical development market as a whole. 2. Demographics & responsibilities of respondents outsourcing cardiac monitoring activities: Shows an in-depth look at the individuals and companies that participated in this research. 3. Cardiac monitoring services: Based on the survey data from biopharmaceutical companies that currently outsource cardiac monitoring activities. This section includes data regarding levels of involvement with cardiac monitoring trials and familiarity with particular service providers. 4. Perspectives on outsourcing from companies that outsource cardiac monitoring activities: Based on the survey data from biopharmaceutical companies that currently outsource cardiac monitoring activities. This section examines the trends in outsourcing behaviors of these companies. 5. Current use of cardiac monitoring within clinical trials: Using the data taken from clinicaltrials.gov, the current state of the cardiac monitoring market is analyzed in terms of phase, methodology, and enrollment figures. 6. Service provider capabilities: Includes capabilities charts for cardiac monitoring service providers as well as company profiles completed by the respective companies Cardiac Monitoring: Market and Outsourcing Dynamics 8

9 Introduction act with confidence Methodology and sources The contents of this report have been gathered from a variety of sources. A minute survey was given to individuals in high ranking positions in the clinical research, pharmaceutical, and biotech industries who outsource their cardiac monitoring activities. Clinical trial data were pulled from clinicaltrials.gov to analyze the current state of the clinical trial space. ISR reached out to cardiac monitoring service providers who provided profiles of their companies. ISR also conducted secondary research to learn more about the companies profiled in this report. ISR believes the content of this report is current and accurate at the time of publication. The sources of this report are outlined below. Primary research 2014 cardiac monitoring outsourcing survey minute web based quantitative and qualitative survey N = 81 respondents from companies who handle or outsource their cardiac monitoring activities for clinical trials Cardiac monitoring company profile questionnaires Of the 19 CROs examined in this report, 5 responded to ISR with completed company profiles. These are included in their entirety in this report Clinicaltrials.gov data From clinicaltrials.gov, ISR identified cardiac monitoring services used by providers (echocardiograph, electrocardiogram, stress test, and t-wave analysis amongst others) and searched trial descriptions for these terms and their variants (for example, ECG may be described as an ECG or electrocardiogram or electrocardiograph ). Of the results returned that contain these terms, ISR manually examined the trials to filter for false positives (while a trial may have ECG in the description, the trial itself may not actually involve the use of an ECG as a monitoring service). The remaining trials and their associated data points were used by ISR for this report. N = 2,587 number of clinical cardiac monitoring trials Secondary research Company and association information were gathered from company websites and publications Cardiac Monitoring: Market and Outsourcing Dynamics 9

10 Executive summary act with confidence Executive summary Cardiac Monitoring: Market and Outsourcing Dynamics 10

11 Executive summary act with confidence Business dynamics Cardiac monitoring services: Current use and expected growth 62% of respondents reported that they have used the 12-lead ECG analysis: Semiautomatic service in the past 12 months the service with the highest reported usage. Similarly, 17% of respondents expected the use of 12-lead ECG analysis: Semiautomatic service to at least somewhat increase over the next two years. The chart below shows the top 5 cardiac monitoring services that have been used in the past 12 months and the percent of respondents that expect the use of these services to at least somewhat increase. 37% of individuals expected Centralized ECG services to at least somewhat increase the service with the highest expected increase in usage. The complete list of services is available in the Study data section. Which of the following ECG/ cardiac monitoring tests have you used in the past 12 months? (Select all that apply) (Base=81) How will your company s use of the following ECG/ cardiac monitoring tests change over the next 24 months? (Base=81) 70% 62% % of respondents 60% 50% 40% 30% 20% 17% 48% 37% 31% 31% 14% 25% 10% 6% 6% 0% 12-lead ECG analysis: Semiautomatic Centralized ECG services Holter for 12-lead ECG collection Reportedly used (past 12 months) 12-lead ECG analysis: Manual Expect to increase 12-lead ECG analysis: Fully manual Additionally, ISR asked respondents how they expect the number of cardiac monitoring studies to grow/decline over the next 18 months. 43% of respondents expect the volume of cardiac monitoring studies to remain roughly constant (+/- 5%). Given all responses, the volume of cardiac monitoring studies is expected to grow 3.6% over the next 18 months. The growth in the cardiac monitoring space exists in the individual services and modalities as opposed to cardiac monitoring as a whole. In other words, 37% of respondents expect the use of Centralized ECG services to increase, but the volume of cardiac monitoring trials is only expected to grow 3.6%, which suggests an increasing proportion of studies will be using Centralized ECG services Cardiac Monitoring: Market and Outsourcing Dynamics 11

12 Executive summary act with confidence Preference for centralized vs. decentralized approach to reading tests The centralized ECG approach is used for the majority of studies (58%). Further, if given the opportunity, 72% of respondents would utilize the centralized approach if they were responsible for designing a study. This suggests that the majority of respondents prefer a centralized approach, but only 58% of cardiac monitoring studies are utilizing a centralized approach. There are two main ways to gather and read ECG results: Centralized and Decentralized. Using a centralized approach all ECGs are conducted and read in a central location. The decentralized approach is when ECGs are taken and read at individual investigative sites. What percent of your ECG studies utilize centralized vs. decentralized approach? Again, your best estimate is fine. (Must equal 100%) (Base=81) Again, thinking about the two main ways to gather and read ECG results: Centralized and Decentralized. If you were designing a clinical study, which approach would you build into the study? (Base=81) Current Use Preference Decentralized Centralized Decentralized Centralized No preference 15% 42% 58% 14% 72% Cardiac Monitoring: Market and Outsourcing Dynamics 12

13 Executive summary act with confidence Cardiac monitoring service provider dynamics Much of this report is dedicated to the outsourcing trends in the cardiac monitoring space. Cardiac monitoring service providers play a valuable role in the clinical trial process and respondents recognize these providers value. 33% of respondents perceive cardiac monitoring service providers as High value-add partners. Only 7% consider cardiac monitoring providers Low value-add vendors. Additionally, of all the cardiac monitoring services required by sponsors, 57% are outsourced to cardiac monitoring service providers. With over half of the cardiac monitoring activities being outsourced, knowing what attributes are most important to a sponsor when selecting a provider, which providers are currently being selected, and which specific activities are being outsourced, are all valuable data points ISR addresses in this section. I view ECG/ cardiac monitoring providers I work with as (Base=81) High value-add partners, 33% Incremental value-add suppliers, 59% Low value-add vendors, 7% Cardiac Monitoring: Market and Outsourcing Dynamics 13

14 Executive summary act with confidence Provider familiarity Respondents were most familiar with the cardiac monitoring services of the major CROs. The chart below shows the top 4 service providers for which respondents were at least moderately familiar with their service offerings. 57% of respondents were at least moderately familiar with Quintiles cardiac monitoring services the provider with the highest reported familiarity. 50% of respondents were at least moderately familiar with ERT s cardiac monitoring services. ERT had the highest reported percentage of respondents that were very familiar with their service offerings 29%. Similarly, 44% of respondents were at least moderately familiar with PAREXEL s cardiac monitoring services, and 41% were at least moderately familiar with ICON s. There is little difference in familiarity amongst the small to mid-sized service providers. The complete list of providers is available in the Study data section. How familiar are you with the ECG services offered by the following providers? (Base=81) 60% 57% % Familiar with Providers Cardiac Monitoring Services 50% 40% 30% 20% 10% 51% 44% 41% 0% Quintiles ERT PAREXEL ICON Cardiac Monitoring: Market and Outsourcing Dynamics 14

15 Executive summary act with confidence Top attributes of cardiac monitoring service providers selected by those outsourcing the service Quality/reliability of the readings was included by the highest number of respondents in the top 5 (93%), top 3 (68%) and top 1 (46%) attributes that are considered when selecting a cardiac monitoring service provider. The most important of these numbers is that almost half of ISR s respondents (46%) believe the Quality/reliability of the readings is the most important attribute. When you are selecting a service provider for your ECG/ cardiac monitoring needs, which 5/3/1 of the following attributes are most important to you? Please select 5/3/1. (Base=81) Quality/ reliability of the readings 46% 68% 93% On-time delivery of ECG/ cardiac safety reports 15% 67% 91% Integration with clinical operations 12% 48% 78% Low cost 12% 32% 53% Top 1 Top 3 Medical/ scientific knowledge of the medical director/ lab head 10% 35% 67% Top 5 Project management of the study 5% 22% 56% Technology/ equipment used 0% 28% 63% 0% 20% 40% 60% 80% 100% % of Respondents that Consider Attribute Important Cardiac Monitoring: Market and Outsourcing Dynamics 15

16 Executive summary act with confidence Likelihood to outsource specific cardiac monitoring services The chart below shows the top 10 cardiac monitoring activities that are at least likely to be outsourced. 63% of respondents are at least likely to outsource their digital equipment needs, and further, 22% are extremely likely to do so. Assist in protocol design was the only service that over half of respondents are not at all likely to outsource (58%). At least half of respondents were at least somewhat likely to outsource the remaining activities. The takeaway: As a cardiac monitoring service provider, marketing the company s capabilities with digital equipment services, standardization of readings across sites, and any of the other top 10 services below is advantageous because it is these activities that customers wish to outsource. The complete list of services is available in the Study data section. Below are several services that an ECG/ cardiac monitoring provider could offer. Please indicate how likely your organization is to outsource each of these services over the next 18 months (Base=81) Extremely likely to outsource Likely to outsource Digital equipment 22% 41% 63% Design the standardization approach for reading ECGs across sites 17% 37% 54% ECG archiving 20% 33% 53% Multilingual 16% 35% 51% Patient Monitoring 12% 38% 51% Wireless monitoring 17% 32% 49% Training of sites 16% 33% 49% Data management 11% 32% 43% Customer care center 12% 30% 42% Development of medical and scientific reports 11% 25% 36% 0% 20% 40% 60% 80% 100% % of respondents at least likely to % of Respondents that Consider Attribute Important Cardiac Monitoring: Market and Outsourcing Dynamics 16

17 Executive summary act with confidence Overview of cardiac monitoring service provider capabilities The capabilities charts included in this report show the capabilities of both the fullservice and dedicated cardiac monitoring CROs that ISR identified in the clinical trial space. Information in these charts is based on secondary research conducted by ISR that examined company websites, brochures, and presentations. Below are the key takeaways ISR learned from this examination. The charts in their entirety are available in the Service Provider Capabilities section: Core lab services: Services such as project management and data storage are commonly advertised by all CROs. However, there are services that these CROs can use to distinguish themselves from competitors such as wireless/remote monitoring or site training. Therapeutic expertise: As this report is focused on cardiac monitoring, all CROs profiled in this report have expertise in cardiology. Some CROs such as CardioCore that specialize in cardiac monitoring provide cardiac services across multiple therapeutic areas. Further, because this report profiles full-service CROs that provide cardiac monitoring services, the full-service CROs have a wide variety of therapeutic expertise as well. Cardiac monitoring services: Similar to the core lab services, there are cardiac monitoring services that appear to be standard across the service providers (12- lead ECG, Holter Monitoring, and BPM). While some CROs clearly differentiate themselves by offering additional or alternative capabilities, it seems that, at least for now, having the primary cardiac monitoring services is most important. Centralized ECG is the service expected to increase in usage over the next few years, and the CROs seem to be responding appropriately 12 of 19 companies advertise this service. Phases of operation: Most of the profiled CROs advertise their cardiac monitoring services for use in Phases I, II, and III. The larger full-service CROs typically operate in the later phases and post-approval as well, but the majority of the cardiac monitoring work appears to take place in clinical development Cardiac Monitoring: Market and Outsourcing Dynamics 17

18 Executive summary act with confidence Overview of company profile results ISR reached out to all of the cardiac monitoring service providers named in this report. Of the 19 companies that are analyzed, six companies provided ISR with thorough company profiles that are provided in this report. From these six respondents, ISR was able to recognize particular trends amongst the cardiac monitoring service providers. 4 of 6 providers list Centralized ECG Services as a top cardiac monitoring service used within the company. 3 of 6 respondents list Thorough Q-wave T-wave (TQT) intensive studies as a primary cardiac monitoring offering. 4 of 6 of providers list CNS as a primary therapeutic area. ISR asked cardiac monitoring service providers how they differentiate themselves within the industry. Of the CROs that ISR spoke with, all advertised their ability to provide quality products and implement innovative techniques to cardiac monitoring services. Other common points of differentiation mentioned were quick turnaround time on readings and ability to navigate the regulatory environment. ISR also asked CRO respondents how they expect their company and the cardiac monitoring space to change in the near future. Respondents expect increased regulatory guidance and earlier involvement of cardiac monitoring teams in trials partly because of the increased regulations but also because a wider variety of issues are being solved by cardiac monitoring services. These trends align well with the outsourcing preferences that ISR heard from survey respondents. Centralized ECG is the cardiac monitoring service that the most respondents expect to increase in usage and, accordingly, is the most listed cardiac monitoring service of the company profile respondents. Additionally, survey data indicate that companies outsourcing their cardiac monitoring activities look for providers to have quality and reliable results. In the provided profiles, all CROs tout their ability to provide quality services, aligning themselves with the most important attribute for service provider selection Cardiac Monitoring: Market and Outsourcing Dynamics 18

19 Study data: Demographics & responsibilities of respondents outsourcing cardiac monitoring activities act with confidence Study Data Cardiac Monitoring: Market and Outsourcing Dynamics 19

20 Study data: Demographics & responsibilities of respondents outsourcing cardiac monitoring activities act with confidence Demographics & responsibilities of respondents outsourcing cardiac monitoring activities Type of organization Please specify the type of organization you work in. (Base=81) Pharmaceutical Company (annual R&D $1B or more) 35% Pharmaceutical Company (annual R&D $500M-$999M) 28% Pharmaceutical Company (annual R&D $100M-$499M) Pharmaceutical Company (annual R&D less than $100M) Biotech Company (annual R&D $1B or more) 7% 7% 10% Biotech Company (annual R&D $500M-$999M) Biotech Company (annual R&D $100M-$499M) 2% 2% Biotech Company (annual R&D less than $100M) 6% Medical Device (annual R&D $1B or more) 1% 0% 10% 20% 30% 40% Cardiac Monitoring: Market and Outsourcing Dynamics 20

21 Study data: Demographics & responsibilities of respondents outsourcing cardiac monitoring activities act with confidence Job titles of respondents What is your job title? (Base=81) Director 48% Manager 44% Vice President 5% C-Level 2% 0% 10% 20% 30% 40% 50% 60% Corporate headquarters/office location Where is your corporate headquarters located? (Base=81) Where is your office located? (Base=81) North America 48% 68% Western Europe 11% 21% Asia (excluding Japan) Central or Eastern Europe 14% 12% 5% 10% Office Headquarters Japan Middle East/India 6% 2% 2% 0% 20% 40% 60% 80% Cardiac Monitoring: Market and Outsourcing Dynamics 21

22 Study data: Demographics & responsibilities of respondents outsourcing cardiac monitoring activities act with confidence Functional areas of responsibility Please specify your functional areas of responsibility within the organization. Please select all that apply. (Base=81) Please specify the one functional area that best matches your responsibility. Please select one. (Base=81) Clinical ops- Project management, Clinical trial lead/ manager 54% 80% R&D Management 16% 31% Executive Management, covering multiple areas 11% 21% Medical 6% 19% Clinical ops- Site Operations, Feasibility, Patient Recruitment 4% 51% Outsourcing / Purchasing Management 5% 28% Clinical Pharmacology / Early Stage Development (Phase I/IIa) 1% 36% Primary functional area Clinical ops- Labs 1% 26% Areas of responsibility Clinical technology 1% 21% Clinical ops- Bios, Data Management, Medical Writing 44% Clinical ops- Safety, Pharmacovigilance Clinical ops- CRA 31% 31% Regulatory Affairs Preclinical Product Development Drug Discovery 14% 12% 12% 0% 20% 40% 60% 80% 100% Cardiac Monitoring: Market and Outsourcing Dynamics 22

23 Study data: Demographics & responsibilities of respondents outsourcing cardiac monitoring activities act with confidence Level of involvement with cardiac monitoring trials Have you been involved in a clinical trial utilizing ECG (electrocardiogram) cardiac monitoring products and services in the past 18 months? (Base=81) Yes, been involved in 3 or more ECG trials 43% Yes, been involved in 2 trials with ECG 21% Yes, been involved in 1 trial with ECG 36% 0% 10% 20% 30% 40% 50% Familiarity with general cardiac monitoring products and services Overall, how familiar are you with ECG (electrocardiogram) cardiac monitoring products and services from companies like Quintiles, ERT, and Biomedical Systems? (Base=81) Very familiar, I have a solid understanding of this technology and its applications for clinical trials 41% Somewhat familiar, I have a basic understanding of the technology and services that surround it 57% 0% 10% 20% 30% 40% 50% 60% Cardiac Monitoring: Market and Outsourcing Dynamics 23

24 Study Data: Cardiac monitoring services act with confidence Cardiac monitoring services Cardiac monitoring services used in past 12 months Which of the following ECG/ cardiac monitoring tests have you used in the past 12 months? (Select all that apply) (Base=81) 12-lead ECG analysis: Semi-automatic 62% Centralized ECG services 48% Holter for 12-lead ECG collection 12-lead ECG analysis: Manual 31% 31% 12-lead ECG analysis: Fully manual ECG stress testing TQT Intensive Studies Echocardiography cardiac imaging Spirometry/ PFT Holter for arrhythmia analysis ABPM - ambulatory blood pressure monitoring 12-lead ECG analysis: Superimposed median beat Genetic testing CEM - cardiac event monitoring T-wave morphology Pulse Wave Analysis Glucometry MUGA multigated acquisition scan 25% 20% 16% 15% 11% 11% 11% 10% 9% 9% 7% 7% 7% 4% 0% 10% 20% 30% 40% 50% 60% 70% Cardiac Monitoring: Market and Outsourcing Dynamics 24

25 Study Data: Cardiac monitoring services act with confidence Growth/decline in use of cardiac monitoring services How will your company s use of the following ECG/ cardiac monitoring tests change over the next 24 months? (Base=81) Increase substantially Increase somewhat No change Decrease somewhat Decrease substantially Have not used, no plans to use Centralized ECG services 12-lead ECG analysis: Semi-automatic CEM - cardiac event monitoring Genetic testing Echocardiography cardiac imaging Holter for 12-lead ECG collection ABPM - ambulatory blood pressure monitoring Holter for arrhythmia analysis 12-lead ECG analysis: Superimposed median beat TQT Intensive Studies T-wave morphology ECG stress testing Glucometry Spirometry/ PFT 4% 1% 16% 1% 15% 14% 14% 1% 12% 1% 12% 12% 1% 10% 1% 9% 9% 9% 1% 6% 16% 33% 63% 47% 48% 56% 54% 48% 42% 51% 47% 51% 52% 51% 52% 2% 44% 6% 4% 2% 2% 4% 4% 5% 5% 1% 5% 4% 2% 1% 2% 4% 1% 7% 2% 6% 5% 1% 1% 2% 4% 4% 4% 5% 35% 33% 36% 33% 37% 27% 31% 27% 31% 32% 25% 30% 11% 11% 12-lead ECG analysis: Manual Pulse Wave Analysis 6% 6% 52% 51% 5% 10% 10% 1% 37% 22% 12-lead ECG analysis: Fully manual Impedance cardiography MUGA multigated acquisition scan 6% 5% 2% 44% 49% 54% 10% 2% 4% 11% 1% 1% 42% 38% 28% 0% 20% 40% 60% 80% 100% Cardiac Monitoring: Market and Outsourcing Dynamics 25

26 act with confidence Perspectives on outsourcing from companies that outsource cardiac monitoring activities Perceived value of cardiac monitoring service providers I view ECG/ cardiac monitoring providers I work with as (Base=81) HIgh value-add partners, 33% Incremental valueadd supliers, 59% Low value-add vendors, 7% Cardiac Monitoring: Market and Outsourcing Dynamics 26

27 act with confidence Service provider familiarity How familiar are you with the ECG services offered by the following providers? (Base=81) Very familiar Moderately familiar Somewhat familiar Not at all familiar ERT 29% 22% 21% 28% Quintiles 27% 30% 26% 17% PAREXEL Informatics 16% 28% 25% 31% ICON 16% 25% 28% 31% Biomedical Systems 14% 21% 16% 49% PPD 12% 26% 27% 35% Cardiocore 11% 16% 20% 53% icardiac 7% 11% 14% 68% CoreLab - BioClinica 6% 16% 16% 62% Clinilabs 5% 17% 26% 52% Cardiabase 5% 10% 16% 69% Cardiolabs 4% 12% 30% 54% Cardio Analytics 4% 10% 16% 70% SGS 4% 7% 19% 2% Spaulding Clinical 4% 19% 1% Medicomp 11% 15% 1% 1% Seahorse Scientific Services 20% 70% 75% 73% 78% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Cardiac Monitoring: Market and Outsourcing Dynamics 27

28 act with confidence Use of centralized vs. decentralized approach to reading tests There are two main ways to gather and read ECG results: Centralized and Decentralized. Using a centralized approach all ECGs are conducted and read in a central location. The decentralized approach is when ECGs are taken and read at individual investigative sites. What percent of your ECG studies utilize centralized vs. decentralized approach? Again, your best estimate is fine. (Must equal 100%) (Base=81) Decentralized Centralized 42% 58% Preference for centralized vs. decentralized approach to reading tests Again, thinking about the two main ways to gather and read ECG results: Centralized and Decentralized. If you were designing a clinical study, which approach would you build into the study? (Base=81) Decentralized Centralized No preference 15% 14% 72% Cardiac Monitoring: Market and Outsourcing Dynamics 28

29 act with confidence Projected growth/decline in cardiac monitoring studies 18 month projection Over the next 18 months, how do you expect the volume of cardiac monitoring studies to change? Your best estimate is fine. (Base=81) MEAN: 3.6% Greatly increase (>20%) 0% Moderately increase (10-20%) 20% Slightly increase (5-10%) 23% Remain roughly constant (+/- 5%) 43% Slightly decrease (-5-10%) 5% Moderately decrease (-10-20%) 5% Greatly decrease (>-20%) 0% Don t know 4% 0% 10% 20% 30% 40% 50% Cardiac Monitoring: Market and Outsourcing Dynamics 29

30 act with confidence Top attributes of cardiac monitoring service providers selected by those outsourcing cardiac monitoring activities When you are selecting a service provider for your ECG/ cardiac monitoring needs, which five (5) of the following attributes are most important to you? Please select five (5). (Base=81) Again, when you are selecting a service provider for your ECG/ cardiac monitoring needs, which three (3) of the following attributes are most important to you? Please select three (3). (Base=81) Finally, when you are selecting a service provider for your ECG/ cardiac monitoring needs, which one (1) of the following attributes is most important to you? Please select one (1). (Base=81) Quality/ reliability of the readings 46% 68% 93% On-time delivery of ECG/ cardiac safety reports 15% 67% 91% Integration with clinical operations 12% 48% 78% Low cost 12% 32% 53% Top 1 Top 3 Medical/ scientific knowledge of the medical director/ lab head 10% 35% 67% Top 5 Project management of the study 5% 22% 56% Technology/ equipment used 0% 28% 63% 0% 20% 40% 60% 80% 100% Cardiac Monitoring: Market and Outsourcing Dynamics 30

31 act with confidence Likelihood to outsource specific cardiac monitoring activities Below are several services that an ECG/ cardiac monitoring provider could offer. Please indicate how likely your organization is to outsource each of these services over the next 18 months (Base=81) Extremely likely to outsource Somewhat likely to outsource Likely to outsource Not at all likely to outsource Digital equipment 22% 41% 22% 15% ECG archiving 20% 33% 30% 17% Design the standardization approach for reading ECGs across sites 17% 37% 27% 19% Wireless monitoring 17% 32% 30% 21% Multilingual 16% 35% 31% 19% Training of sites 16% 33% 36% 15% Patient Monitoring 12% 38% 28% 21% Customer care center 12% 30% 19% 40% Data management 11% 32% 30% 27% Development of medical and scientific reports 11% 25% 42% 22% Development of ECG acquisition guidelines 10% 43% 31% 16% Consulting to determine the appropriate ECG technology and mix 10% 35% 33% 22% Statistical analysis 10% 19% 23% 48% Development of the statistical analysis plan 7% 17% 31% 44% Automated platforms 5% 32% 30% 33% IRB assistance 5% 30% 20% 46% Safety report/monitoring 5% 26% 31% 38% Assist in protocol design Creating the ECG components of regulatory submissions Regulatory consulting and support 5% 17% 4% 26% 2% 23% 20% 35% 37% 58% 33% 40% 0% 20% 40% 60% 80% 100% Cardiac Monitoring: Market and Outsourcing Dynamics 31

32 act with confidence Percent of cardiac monitoring activities that are outsourced Over the past 18 months, what percent of your ECG/ cardiac monitoring activities have been or are conducted using an outsourced service provider/ CRO? Your best estimate is fine. (Base=81) MEAN: 57% % 27% 81-90% 7% % of Activities Outsourced 71-80% 61-70% 51-60% 41-50% 31-40% 21-30% 11-20% 0-10% 7% 6% 5% 6% 5% 12% 11% 12% 0% 5% 10% 15% 20% 25% 30% 35% Cardiac Monitoring: Market and Outsourcing Dynamics 32

33 act with confidence Percent of cardiac monitoring activities to be outsourced 18 month projection Over the next 18 months, what percent of your ECG/ cardiac monitoring activities have been or are conducted using an outsourced service provider/ CRO? Your best estimate is fine. (Base=81) MEAN: 58% % 32% % of Activities Outsourced 81-90% 71-80% 61-70% 51-60% 41-50% 31-40% 21-30% 11-20% 1% 5% 5% 7% 9% 9% 11% 15% 0-10% 6% 0% 5% 10% 15% 20% 25% 30% 35% Cardiac Monitoring: Market and Outsourcing Dynamics 33

34 Current use of cardiac monitoring within clinical trials act with confidence Current use of cardiac monitoring within clinical trials ISR gathered cardiac monitoring trial data from clinicaltrials.gov for this portion of the report. Again, ISR identified cardiac monitoring services used by providers (echocardiograph, electrocardiogram, stress test, and t-wave analysis amongst others) and searched trial descriptions for these terms and their variants (for example, ECG may be described as an ECG or electrocardiogram or electrocardiograph ). The data reflect those clinical trials that were first submitted to clinicaltrials.gov between 2010 and Under, for example, the 2010 columns in the subsequent charts, the data reflect those trials that were first submitted to the clinicaltrials.gov website in Some of the trials detailed in this report are completed while others are ongoing. The following data show, first, the data for all cardiac monitoring trials and, second, the data reflecting interventional trials specifically Cardiac Monitoring: Market and Outsourcing Dynamics 34

35 Current use of cardiac monitoring within clinical trials act with confidence Number of clinical cardiac monitoring trials by phase Results are based on the number of trials (N=2,587) reported by clinicaltrials.gov to contain one of the cardiac monitoring services (or variations of that service) in the trial s description. How to read the table: Of the 800 cardiac monitoring trials first submitted in 2010, 232 (29%) were Phase I Total Phase 0 6 (1%) 4 (1%) 10 (1%) 3 (1%) 23 (1%) Phase I 232 (29%) 194 (28%) 177 (24%) 86 (24%) 689 (27%) Phase II 140 (18%) 114 (17%) 134 (18%) 58 (16%) 446 (17%) Phase III 82 (10%) 90 (13%) 55 (7%) 25 (7%) 252 (10%) Phase IV 73 (9%) 67 (10%) 80 (11%) 27 (8%) 247 (10%) No Phase 267 (33%) 220 (32%) 288 (39%) 155 (44%) 930 (36%) Total 800 (31%) 689 (27%) 744 (29%) 354 (14%) 2,587 Number of cardiac monitoring trials by phase industry only Results are based on the number of trials handled by industry (N=1,203) reported by clinicaltrials.gov to contain one of the cardiac monitoring services (or variations of that service) in the trial s description. How to read the table: Of the 419 industry-funded cardiac monitoring trials first submitted in 2010, 212 (51%) were Phase I Total Phase 0 2 (0%) - 1 (0%) - 3 (0%) Phase I 212 (51%) 156 (46%) 141 (46%) 68 (49%) 577 (48%) Phase II 96 (23%) 74 (22%) 73 (24%) 23 (17%) 266 (22%) Phase III 47 (11%) 62 (18%) 31 (10%) 16 (12%) 156 (13%) Phase IV 29 (7%) 18 (5%) 26 (8%) 5 (4%) 78 (6%) No Phase 33 (8%) 27 (8%) 37 (12%) 26 (19%) 123 (10%) Total 419 (35%) 337 (28%) 309 (26%) 138 (11%) 1, Cardiac Monitoring: Market and Outsourcing Dynamics 35

36 Current use of cardiac monitoring within clinical trials act with confidence Average number of patients in cardiac monitoring trials by phase Results are based on the number of trials (N=2,587) reported by clinicaltrials.gov to contain one of the cardiac monitoring services (or variations of that service) 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 trials in that phase taking place). How to read chart: In 2010, of the 232 Phase I cardiac monitoring trials submitted, there was an average of 46 patients participating in each trial Total Phase (N=6) 52 (N=4) 280 (N=10) 112 (N=3) 175 (N=23) Phase I 46 (N=232) 50 (N=194) 52 (N=177) 45 (N=86) 49 (N=689) Phase II 78 (N=140) 80 (N=114) 91 (N=134) 106 (N=58) 86 (N=446) Phase III 439 (N=82) 382 (N=90) 278 (N=55) 493 (N=25) 464 (N=252) Phase IV 415 (N=73) 251 (N=67) 345 (N=80) 96 (N=27) 313 (N=247) No Phase 299 (N=267) 531 (N=220) 565 (N=288) 501 (N=155) 470 (N=930) Total 211 (N=800) 267 (N=689) 309 (N=744) 290 (N=354) 265 (N=2,587) Cardiac Monitoring: Market and Outsourcing Dynamics 36

37 Current use of cardiac monitoring within clinical trials act with confidence Average number of patients in cardiac monitoring trials by phase - industry only Results are based on the number of trials handled by industry (N = 1,203) reported by clicaltrials.gov to contain one of the cardiac monitoring services (or variations of that service) in the trial s description. The chart reports the average number of patients participating in cardiac monitoring trials by phase (as well as the total number of that phase s trials taking place). How to read chart: In 2010, of the 212 industry funded Phase I cardiac monitoring trials that were submitted, there was an average of 48 patients participating in each trial Total Phase (N=2) - 54 (N=1) (N=3) Phase I 48 (N=212) 50 (N=156) 50 (N=141) 47 (N=68) 49 (N=577) Phase II 92 (N=96) 86 (N=74) 87 (N=73) 79 (N=23) 88 (N=266) Phase III 384 (N=47) 495 (N=62) 372 (N=31) 267 (N=16) 451 (N=156) Phase IV 860 (N=29) 82 (N=18) 707 (N=26) 88 (N=5) 580 (N=78) No Phase 394 (N=33) 350 (N=27) 334 (N=37) 993 (N=26) 489 (N=123) Total 180 (N=419) 156 (N=337) 181 (N=309) 252 (N=138) 182 (N=1,203) Average number of patients in interventional cardiac monitoring trials by phase Results are based on the number of interventional cardiac monitoring trials (N=2,058) since The chart below shows the average number of patients involved in interventional cardiac monitoring trials since How to read chart: Of the 232 interventional Phase I trials first submitted in 2010, the average number of patients in those trials was Total Phase (N=5) 20 (N=2) 108 (N=7) 112 (N=3) 102 (N=17) Phase I 46 (N=232) 50 (N=191) 52 (N=177) 45 (N=86) 49 (N=686) Phase II 78 (N=140) 80 (N=114) 85 (N=132) 107 (N=57) 84 (N=443) Phase III 447 (N=79) 352 (N=89) 274 (N=54) 493 (N=25) 380 (N=247) Phase IV 118 (N=70) 255 (N=66) 164 (N=75) 96 (N=27) 168 (N=238) No Phase 239 (N=123) 715 (N=103) 287 (N=128) 237 (N=73) 368 (N=427) Total 147 (N=649) 249 (N=565) 148 (N=573) 157 (N=271) 177 (N=2,058) Cardiac Monitoring: Market and Outsourcing Dynamics 37

38 Current use of cardiac monitoring within clinical trials act with confidence Average number of patients in interventional cardiac monitoring trials by phase industry only Results are based on the number of industry-sponsored interventional cardiac monitoring trials (N=1,122) since The chart below shows the average number of patients involved in industry-sponsored interventional cardiac monitoring trials since How to read chart: Of the 212 industry-sponsored interventional Phase I trials that were submitted in 2010, the average number of patients in those trials was Total Phase (N=1) - 54 (N=1) (N=2) Phase I 48 (N=212) 50 (N=155) 50 (N=141) 47 (N=68) 49 (N=576) Phase II 92 (N=96) 86 (N=74) 88 (N=72) 79 (N=23) 88 (N=265) Phase III 384 (N=47) 447 (N=61) 372 (N=31) 267 (N=16) 394 (N=155) Phase IV 110 (N=27) 82 (N=18) 141 (N=22) 88 (N=5) 111 (N=72) No Phase 144 (N=12) 127 (N=16) 199 (N=11) 144 (N=13) 150 (N=52) Total 106 (N=395) 139 (N=324) 109 (N=278) 93 (N=125) 115 (N=1,122) Cardiac Monitoring: Market and Outsourcing Dynamics 38

39 Current use of cardiac monitoring within clinical trials act with confidence Cardiac monitoring trials by sponsor company How to read chart: In 2010, GlaxoSmithKline oversaw 39 cardiac monitoring trials. Company Total GlaxoSmithKline Pfizer Janssen AstraZeneca Astellas Bristol-Myers Squibb Johnson & Johnson Boehringer Ingelheim Amgen Novartis Novartis Pharmaceuticals Sanofi Tibotec Merck Eisai St. Jude Medical Cardiac Monitoring: Market and Outsourcing Dynamics 39

40 Current use of cardiac monitoring within clinical trials act with confidence Cardiac monitoring trials by sponsor type Results are based on the number of trials (N=2,587) reported by clinicaltrials.gov to contain one of the cardiac monitoring services (or variations of that service) in the trial s description. The chart below reports what sector funded the 2,587 trials involving cardiac monitoring that have occurred since Because multiple trials have been funded by multiple sources, the total number of trials down each column is greater than the number shown in the total row. How to read chart: In 2010, 419 (45%) of the 800 trials involving cardiac monitoring were at least partially industry-sponsored Total Industry 419 (52%) 337 (49%) 309 (42%) 138 (39%) 1,203 (47%) NIH 43 (5%) 38 (6%) 43 (6%) 17 (5%) 141 (5%) Other 451 (56%) 394 (57%) 486 (65%) 238 (67%) 1,569 (61%) U.S. Fed 13 (2%) 5 (1%) 16 (2%) 6 (2%) 40 (2%) Total ,587 Number of interventional cardiac monitoring trials by phase Results are based on the number of interventional trials (N=2,058) to have taken place since 2010 to contain one of the cardiac monitoring services in the trial s description. The chart below shows the distribution of interventional studies by phase. How to read chart: Of the 649 interventional studies involving cardiac monitoring that were submitted in 2010, 232 (36%) were Phase I studies Total Phase 0 5 (1%) 2 (0%) 7 (1%) 3 (1%) 17 (1%) Phase I 232 (36%) 191 (34%) 177 (31%) 86 (32%) 686 (33%) Phase II 140 (22%) 114 (20%) 132 (23%) 57 (21%) 443 (22%) Phase III 79 (12%) 89 (16%) 54 (9%) 25 (9%) 247 (12%) Phase IV 70 (11%) 66 (12%) 75 (13%) 27 (10%) 238 (12%) No Phase 123 (19%) 103 (18%) 128 (22%) 73 (27%) 427 (21%) Total , Cardiac Monitoring: Market and Outsourcing Dynamics 40

41 Current use of cardiac monitoring within clinical trials act with confidence Number of interventional cardiac monitoring trials by phase industry only Results are based on the number of industry-sponsored interventional cardiac monitoring trials (N=1,122) to have taken place since The chart shows the distribution of industry-sponsored interventional studies by phase. How to read chart: Of the 395 industry-sponsored interventional studies that took place in 2010, 212 (54%) were Phase I studies Total Phase 0 1 (0%) - 1 (0%) - 2 (0%) Phase I 212 (54%) 155 (48%) 141 (51%) 68 (54%) 576 (51%) Phase II 96 (24%) 74 (23%) 72 (26%) 23 (18%) 265 (24%) Phase III 47 (12%) 61 (19%) 31 (11%) 16 (13%) 155 (14%) Phase IV 27 (7%) 18 (6%) 22 (8%) 5 (4%) 72 (6%) No Phase 12 (3%) 16 (5%) 11 (4%) 13 (10%) 52 (5%) Total , Cardiac Monitoring: Market and Outsourcing Dynamics 41

42 Service provider capabilities Service provider capabilities Cardiac Monitoring: Market and Outsourcing Dynamics 42

43 Service provider capabilities Capabilities charts The following charts show the core lab services, cardiac monitoring services, phases of operation, and therapeutic expertise of both the dedicated cardiac monitoring CROs and full-service CROs. This section can be used by companies that outsource their cardiac monitoring services to determine which providers will be able to satisfy their needs. Additionally, cardiac monitoring service providers, regardless of whether they are listed in this report, can use this section to gauge how their offerings compare to their competitors offerings. The majority of these data were taken from company websites. These data were gathered from a search of provider websites and may not capture 100% of the cardiac monitoring capabilities offered by these providers. It does however show a comparison of what providers are advertising on their websites and in industry publications. BioClinica Biomedical Systems Cardiolabs Celerion ERT ICON Integrium PAREXEL PPD Quintiles Seahorse Scientific Services SGS Spaulding Clinical Cardiabase Cardioanalytics Cardiocore Clinilabs icardiac Medicomp Core lab services Automated Platforms Customer Care Center Data Storage Digital Equipment General Consulting Multilingual Services Paper Processing Patient Monitoring Project Management Cardiac Monitoring: Market and Outsourcing Dynamics 43

44 Service provider capabilities BioClinica Biomedical Systems Cardiolabs Celerion ERT ICON Integrium PAREXEL PPD Quintiles Seahorse Scientific Services SGS Spaulding Clinical Cardiabase Cardioanalytics Cardiocore Clinilabs icardiac Medicomp Protocol Development Quality Assurancce Regulatory Guidance Safety Report/ Monitoring Site Training/ Monitoring Statistical Analysis Strategic Planning Wireless Monitoring Phases of Operation Not listed Pre-Clinical Phase I Phase II Phase III Phase IV Post-Approval Cardiac Services 12-Lead ECG Blood Pressure Monitoring Cardiac Monitoring: Market and Outsourcing Dynamics 44

45 Service provider capabilities BioClinica Biomedical Systems Cardiolabs Celerion ERT ICON Integrium PAREXEL PPD Quintiles Seahorse Scientific Services SGS Spaulding Clinical Cardiabase Cardioanalytics Cardiocore Clinilabs icardiac Medicomp Cardiac Event Monitoring Centralized ECG Analysis ECG Stress Testing Echocardiography Holter Monitoring Impedance Cardiography Pulse Wave Analysis TQT/Intensive Studies T-Wave Morphology Therapeutic Areas General Addiction Allergy Cardiology CNS Dermatology Endocrinology Gastroenterology Hematology Cardiac Monitoring: Market and Outsourcing Dynamics 45

46 Service provider capabilities BioClinica Biomedical Systems Cardiolabs Celerion ERT ICON Integrium PAREXEL PPD Quintiles Seahorse Scientific Services SGS Spaulding Clinical Cardiabase Cardioanalytics Cardiocore Clinilabs icardiac Medicomp Immunology Infectious Disease Medical Devices Medical Imaging Metabolic Disease Musculoskeletal Nephrology Neurology Neurophysiology Oncology Opthalmology Pathology Psychiatric Illness Pulmonary/ Respiratory Renal Disease Respiratory Rheumatology Urology Virus/Vaccines Cardiac Monitoring: Market and Outsourcing Dynamics 46

47 Service provider capabilities Company profiles - Dedicated cardiac monitoring CROs ISR reached out to representatives from the cardiac monitoring service providers listed in the above section and asked that they fill out a brief company profile questionnaire concerning their cardiac monitoring services, capabilities, therapeutic expertise, and points of differentiation. The following companies replied to ISR s request and provided company profiles. The following text appears as it was sent by the respective companies. BioClinica Company overview With over 25 years of experience in cardiac monitoring services, BioClinica is a recognized global leader in providing comprehensive services with unrivalled scientific and technical leadership. BioClinica s medical and scientific team of board-certified cardiologists has experience in successfully designing and supporting cardiac monitoring studies. We have experience working alongside the ICH, FDA, EMA, PMDA, and C-FDA for the development of regulatory and industry guidelines. Our focus goes beyond the single study and across the entire cardiac monitoring profile of a study compound from Phase I IV. BioClinica offers a full range of digital ECG technology and comprehensive ECG services across all clinical study Phases. Our capabilities include direct ECG data transfer from Clinical Pharmacology Units to our technology platform, reducing the need to provide the clinical unit with ECG equipment. We offer full TQT study support, including concept and protocol design, ECG management and analysis, statistical analysis, expert reporting and regulatory support. BioClinica is an international leader and innovator of blood pressure solutions, including Ambulatory Blood Pressure Monitoring, 24 hour pulse wave assessment and Cardiac Monitoring: Market and Outsourcing Dynamics 47

48 Service provider capabilities remote home BP telemonitoring and centralized office BP solutions. These services are provided through innovative technology and full project and site management to fit the specific needs of a clinical trial design. We have the scientific expertise and technological capabilities to offer cardiac monitoring through a wide range of conventional and nuclear medicine imaging modalities including CT, ECHO, MRI, PET, MUGA and SPECT. Clinical ECG study involvement BioClinica has averaged between 40 and 45 active simultaneous studies in Basic service offerings Assist in protocol design Automated platforms Consulting to determine the appropriate ECG technology and mix Creating the ECG components of regulatory submissions Data management Design the standardization approach for reading ECGs across sites Development of ECG acquisition guidelines Development of medical and scientific reports Development of the statistical analysis plan Digital equipment ECG archiving IRB assistance Multilingual Patient Monitoring Regulatory Consulting and support Safety report/monitoring Statistical analysis Training of sites Wireless Monitoring Cardiac Monitoring: Market and Outsourcing Dynamics 48

49 Service provider capabilities Cardiac monitoring service offerings (top 3 bolded) 12-lead ECG analysis: Fully manual 12-lead ECG analysis: Manual 12-lead ECG analysis: Semi-automatic 12-lead ECG analysis: Superimposed median beat ABPM - ambulatory blood pressure monitoring Centralized ECG services ECG stress test reporting Echocardiography cardiac imaging Holter for 12-lead ECG collection Holter for arrhythmia analysis MUGA multigated acquisition scan Pulse Wave Analysis TQT Intensive Studies T-wave morphology Other, please specify: Cardiac imaging analysis including ECHO, Cardiac MRI and Cardiac CT Remote home Blood Pressure monitoring Centralized office Blood Pressure monitoring Therapeutic area coverage (top 3 bolded) Allergy Cardiology CNS Dermatology Endocrinology Gastroenterology Hematology Infectious Disease Medical Devices Medical Imaging Metabolic Disease Cardiac Monitoring: Market and Outsourcing Dynamics 49

50 Service provider capabilities Musculoskeletal Nephrology Neurology Oncology Psychiatric Illness Pulmonary/Respiratory Renal Disease Rheumatology Urology Virus/Vaccines Other, please specify: Pediatrics Points of differentiation BioClinica offers comprehensive cardiovascular safety solutions supporting ECG measurements, ABPM monitoring, and cardiac imaging. We have extensive expertise with TQT study design and are the largest, most experienced provider of ABPM and other hemodynamic services. Members of our cardiac monitoring team have a great deal of experience in supporting trials on a global level across a wide range of therapeutic indications and trial Phases. We understand that each study is unique and we work with our sponsors to generate an effective cardiac monitoring solution while providing continuous site support to ensure high quality data. BioClinica has successfully completed the first regulatory-mandated TQT study in both Japan and in China and are the only core lab to have developed a novel TQT study design (nested crossover) which allows sponsors to substantially cut the size and cost of their studies. Our regulatory expertise spans multiple agencies including the FDA, EMA, PMDA and C-FDA and we have an active role within the cardiac monitoring Research Consortium (CSRC) and the Metrics Champion Consortium (MCC) Cardiac Monitoring: Market and Outsourcing Dynamics 50

51 Service provider capabilities Expected company/industry changes Until very recently the cardiac monitoring field was limited to repolarization-related cardiotoxicity, primarily focusing on drug induced QT prolongation, arrhythmia and sudden cardiac death. This has resulted in the ICH-E14 guidance, which requires a Thorough QT (TQT) study for most new drugs as a condition for approval. More recently the field expanded to include wider Cardiovascular (CV) Safety issues including tissue damage, vascular damage; hemodynamic and cardio-metabolic effects (notice the shift from cardiac monitoring to cardiovascular safety ). Cardio-Oncology is a rapidly evolving clinical and pharmaceutical field and a growing body of evidence provides a very strong testimony for its growing recognition and impact. Cardio-oncology is primarily concerned with direct effect of cytotoxic drugs on the myocardial tissue, essentially leading to heart failure (HF) and possibly premature death. The recent high profile withdrawals of drugs implicated with Vascular-related cardiotoxicity and cardio-metabolic effect, including the Avandia (rosiglitazone) association with myocardial infarction and heart failure, led the FDA and EMA to introduce new guidance aimed at improving the CV Safety of new antidiabetes drugs. The diabetes CV safety guidance requires that new anti-diabetes drugs undergo large (and expensive) CV Outcome trials to demonstrate their CV safety. Other vascular-related cardiotoxicity issues include thrombotic effects (e.g., COX-2 inhibitors, including Rofecoxib (Vioxx)), endothelial effects (e.g., VEGF inhibitors) and blood pressure effects, possibly leading to hypertension. Drug induced blood-pressure changes, including hypertension, have been associated with many drug classes most notably with VEGF inhibitors, (e.g., Bevacizumab, Avastin), and other vasoactive oncology agents, triggering regulatory and clinical concerns for a new paradigm for BP assessment in drug development Cardiac Monitoring: Market and Outsourcing Dynamics 51

52 Service provider capabilities Cardiabase Company overview Banook Group s CardiaBase is a cardiac Core Laboratory specialised in the processing, analysis and reporting of cardiac monitoring and efficacy data since 1999 in the heart of Europe. As the result of continuous research and innovation CardiaBase is today a mature and reputable organisation that provides services to more than 35 international pharmaceutical companies, device manufacturers and biotechnology companies on a global basis. Services include an assessment strategy fully integrated with your clinical development plan, protocol design, analysis and interpretation, direct interaction with regulatory agencies and Phase I clinics in Europe and North America. The combination of medical, scientific, regulatory and technical expertise has made Cardiabase a global leader in the field, with a contribution to more than 500 studies in over 70 countries and thousands of clinical sites. Clients are increasingly recognising the high quality of our Phase I-IV clinical development services as highly reliable, based on our capacity to enhance the clinical trial process with advanced metrics that improve clinical trial planning and prevent delays. Our high standards of excellence have led several major pharmaceutical companies to select us as their preferred provider for cardiac monitoring and event adjudication services. Services include: Scientific and Regulatory Consulting, Phase I:- Early QT and non-qt; E14 TQT; Oncology TQT, Centralized ECG Services for Phase II IV, Digital & Paper ECG Capabilities, Centralized Holter Services: 2, 3, 12-Lead; 10 sec extracted; Cardiac arrhythmias, Centralized ABPM Services, MACE ADJUDICATION - Major Adverse Cardiac Events Cardiac Monitoring: Market and Outsourcing Dynamics 52

53 Service provider capabilities Clinical ECG study involvement At any one time, we will be averaging between 40 and 50 Studies. Basic service offerings Assist in protocol design Automated platforms Consulting to determine the appropriate ECG technology and mix Creating the ECG components of regulatory submissions Customer care center Data management Design the standardization approach for reading ECGs across sites Development of ECG acquisition guidelines Development of medical and scientific reports Development of the statistical analysis plan Digital equipment ECG archiving IRB assistance Multilingual Regulatory consulting and support Safety report/monitoring Statistical analysis Training of sites Wireless monitoring Cardiac monitoring service offerings (top 3 bolded) 12-lead ECG analysis: Fully manual 12-lead ECG analysis: Manual 12-lead ECG analysis: Semi-automatic 12-lead ECG analysis: Superimposed median beat ABPM - ambulatory blood pressure monitoring CEM - cardiac event monitoring Cardiac Monitoring: Market and Outsourcing Dynamics 53

54 Service provider capabilities Centralized ECG services ECG stress testing Holter for 12-lead ECG collection Holter for arrhythmia analysis TQT Intensive Studies T-wave morphology Therapeutic area coverage (top 3 bolded) Allergy Cardiology CNS Dermatology Hematology Immunology Infectious Disease Medical Devices Medical Imaging Metabolic Disease Musculoskeletal Neurology Oncology Psychiatric Illness Pulmonary/Respiratory Rheumatology Urology Virus/Vaccines Points of differentiation Scientific and Medical Expertise that is unmatched by other core labs. One of the most experienced ECG core labs on the globe with continuous operations under the same ownership group since Cardiac Monitoring: Market and Outsourcing Dynamics 54

55 Service provider capabilities Affiliations with world class research organizations such as the Institute Gustave Roussy. Robust infrastructure that can support small Early Phase development studies to multi-center, global Phase III and Post Marketing Safety studies. Competitive pricing that allows you to offer your clients best in class services at lower rates. Mitigating risk by providing the personnel, the infrastructure, the expertise, the experience and the pricing to make you a clear choice in the bidding process. Expected company/industry changes As of today, a formal TQT study design is required for any non-cardiovascular compound with systemic exposure. However, conducting a formal TQT is typically based on a Clinical Pharmacology Table that includes, among other features, knowledge on the therapeutic dose and the compounds ADME data. Therefore, it cannot be conducted too early in a development program. The outcome from a TQT Study can be a veritable death sentence to its continued development i.e. a no-go decision if the TQT is coined as positive. This is driving a trend to obtain reliable data on the QT liability at an early level in the clinical development cycle, during the so called SAD and MAD studies of Phase I. There is growing accumulated evidence that good ECG data can be collected in such early Phase I Studies. The cardiac monitoring Research Consortium (CSRC) will soon conduct a trial under the auspices of the IQ (Innovation and Quality) working group to determine how reliable these early Phase I studies truly are. In a similar vein, the preclinical QT packages remain based on the 2005 ICH S7B requirements. Banook Group s CardiaBase scientific experts are often asked to establish a QT Expert Report that combines both preclinical and human data. The CSRC/HESI group have established a Thinktank with the objectives to mainly focus on Torsade Risk rather than focusing on the QT surrogate end-point. We carefully follow this Thinktank, and are confident that its deliberations will significantly impact our experts reports in the very near future. In summary, there is need for better and earlier identification of any cardiovascular safety liability in a given compound. Attendance at all CSRC meetings is central for CardiaBase in preparation for the paradigm shift in Arrhythmia Risk Assessment that will emerge, and its impact on our recommendations to our clients Cardiac Monitoring: Market and Outsourcing Dynamics 55

56 Service provider capabilities icardiac Company overview icardiac Technologies is a full-service Next Generation ECG Core Lab. We are the fastest growing, core laboratory in the industry dedicated to cardiac monitoring services. Our executive team has extensive expertise and many years of experience in technology enabled service-oriented companies, including clinical technology service providers in pharmaceutical development industry. Our company s core values are deeply rooted in improving the field of pharmaceutical cardiac monitoring by developing sophisticated technologies that enable highly precise ECG measurements and deliver earlier, more cost effective and accurate decision making for our clients - research based pharmaceutical companies. We believe that excellence in cardiac monitoring sciences comes from successful long-term collaboration with pharmaceutical sponsors and CROs and from our deep commitment to service and customer satisfaction. Clinical ECG study involvement 40 to 60 studies Basic service offerings Automated platforms Consulting to determine the appropriate ECG technology and mix Creating the ECG components of regulatory submissions Customer care center Data management Design the standardization approach for reading ECGs across sites Development of ECG acquisition guidelines Development of medical and scientific reports Development of the statistical analysis plan Digital equipment ECG archiving Multilingual Cardiac Monitoring: Market and Outsourcing Dynamics 56

57 Service provider capabilities Regulatory consulting and support Safety report/monitoring Statistical analysis Training of sites Wireless monitoring Other, please specify: standardized ECG and Holter equipment provision, programming, global logistics, 24/7 tech support for clinical sites; web reporting tools for sites, sponsors and CROs; advanced ECG and Holter analytics. Cardiac monitoring service offerings (top 3 bolded) 12-lead ECG analysis: Fully manual 12-lead ECG analysis: Manual 12-lead ECG analysis: Semi-automatic ABPM - ambulatory blood pressure monitoring CEM - cardiac event monitoring Centralized ECG services Holter for 12-lead ECG collection Holter for arrhythmia analysis TQT Intensive Studies T-wave morphology Other, please specify: Advanced ECG and Holter analytics High Precision QT; QT beat-to-beat; Restitution; Quantitative T-wave analysis; HRV; custom-designed analytics. Therapeutic area coverage (top 3 bolded) Addiction Cardiology CNS Dermatology Gastroenterology Hematology Immunology Cardiac Monitoring: Market and Outsourcing Dynamics 57

58 Service provider capabilities Infectious Disease Medical Devices Medical Imaging Metabolic Disease Musculoskeletal Neurology Oncology Opthalmology Psychiatric Illness Pulmonary/Respiratory Rheumatology Urology Points of differentiation icardiac is the market leader in development and validation (including Regulatory validation and acceptance) of advanced ECG and Holter based analytics. icardiac provides several proprietary, validated and FDA-accepted ECG and Holter measurement methodologies. Specifically, the High Precision QT Analysis improves the precision of ECG interval measurements by 60 % compared to semi-automated or manual techniques. This improvement in precision increases the power of a TQT trial, and reduces the risk of failing the moxifloxacin assay sensitivity test. In fact, icardiac has never failed a moxifloxacin test in a TQT trial, while for the industry overall the failure rate is approximately 12% (32 of 277 studies in the FDA ECG Warehouse to date). icardiac s proprietary QT beat-to-beat and Optimized QTcI methodologies have been accepted by the FDA as more accurate methods for studying QT effects of the drugs that also have an effect on the heart rate, autonomic tone and/or blood pressure. icardiac offers the most innovative solutions for Phase II-IV global multi-site cardiac monitoring services. We maintain global inventory of remotely programmable ECG and Holter equipment which enables us to provide shortest start-up times, and ensure fastest resolution of any technical issues for the investigative sites. icardiac track record is 100% on time for study deliverables in the 7+ years of our company s history. Most importantly, icardiac is differentiated by an exceptional level of customer service and dedication of our staff to providing the most positive, productive and collaborative experience to our clients pharmaceutical sponsors, CROs and investigative sites Cardiac Monitoring: Market and Outsourcing Dynamics 58

59 Service provider capabilities Expected company/industry changes icardiac has been an active participant and a driver of change in the pharmaceutical cardiac monitoring industry. We have pioneered and achieved regulatory acceptance for more computerized ECG and Holter analysis techniques. In 2009 icardiac was the first ECG core lab achieving global market clearance for a drug using a sophisticated computerized ECG reading methodology. Currently, icardiac is collaborating with the cardiac monitoring Research Consortium and FDA on IQ-CSRC initiative. This initiative is developing and alternative regulatory pathway for completing the required characterization of the drug s effect on repolarization (TQT trial) within existing single and multiple-ascending dose studies. Once completed, this pathway will enable the sponsors to preform earlier and much more cost-effective evaluation of some drugs in development for QT and other electrocardiographic effects Cardiac Monitoring: Market and Outsourcing Dynamics 59

60 Service provider capabilities Company profiles - Full-service CROs Biomedical Systems Company overview For over 25 years, Biomedical Systems has been supporting our clients digital ECG clinical trial needs providing centralized ECG services in over 2,500 studies. We continue to maintain our position as a global leader in centralized diagnostics testing by investing in the things that are most important to sponsors; well-trained people, state-of-the-art equipment and systems, and the infrastructure to support international studies. Clients utilizing Biomedical Systems centralized ECG services enjoy real time access to clinical trial data via Biomedical Systems proprietary BMS Gateway ECG management system. BMS gateway provides secure, instant access based on user rights to essential study information including ECGs, PDFs of site printouts, alerts, metrics, shipping, and financials. Data can be downloaded onto an excel spreadsheet and sorted to produce reports that meet clients immediate needs. Expert Analysis Single cardiologist over-reader assigned per study, with the exception of accelerated TQT studies Complete Inter/Intra reader variability program Equipment Advantages 21 CFR Part 11 electronic documents and electronic audit trail compliance Complete 10-second electronic digital raw ECG waveforms with electronic storage Electronically captured cardiologist s annotations, all ECG interval onsets and offsets Transmission & Access BMS Gateway web-based access to data and reports 24/7/365 customer service and technical support Protocol specific metrics available Data verified and cleaned before electronic submission Cardiac Monitoring: Market and Outsourcing Dynamics 60

61 Service provider capabilities Clinical ECG study involvement Actively involved in 200 studies at any given time Basic service offerings Assist in protocol design Automated platforms Consulting to determine the appropriate ECG technology and mix Creating the ECG components of regulatory submissions Customer care center Data management Design the standardization approach for reading ECGs across sites Development of ECG acquisition guidelines Development of medical and scientific reports Development of the statistical analysis plan Digital equipment ECG archiving Multilingual Patient Monitoring Regulatory consulting and support Safety report/monitoring Statistical analysis Training of sites Wireless monitoring Cardiac monitoring service offerings (top 3 bolded) 12-lead ECG analysis: Manual 12-lead ECG analysis: Semi-automatic 12-lead ECG analysis: Superimposed median beat ABPM - ambulatory blood pressure monitoring CEM - cardiac event monitoring Centralized ECG services ECG stress testing Echocardiography cardiac imaging Holter for arrhythmia analysis Impedance cardiography Pulse Wave Analysis Spirometry/ PFT TQT Intensive Studies T-wave morphology Cardiac Monitoring: Market and Outsourcing Dynamics 61

62 Service provider capabilities Therapeutic area coverage (top three bolded) Addiction Allergy Cardiology CNS Dermatology Endocrinology Gastroenterology Hematology Immunology Infectious Disease Medical Devices Medical Imaging Metabolic Disease Musculoskeletal Nephrology Neurology Neurophysiology Oncology Ophthalmology Pathology Pulmonary/Respiratory Renal Disease Rheumatology Urology Points of Differentiation Cardiac Safety Overall Strengths a. Equipment Options b. Breadth of Services c. Experience d. Expertise e. History / track record Expected company/industry changes The TQT analysis becoming less frequent as companies place less emphasis on this safety component in the trials. The use of a more fully automated approach to ECG s analysis, and cost Cardiac Monitoring: Market and Outsourcing Dynamics 62

63 Service provider capabilities Quintiles Company overview Quintiles cardiac monitoring Services, formerly known as Cardiac Alert, began in 1997, was acquired by Quintiles in 1998, and has been operating since January 2002 from Mumbai, India. Quintiles cardiac monitoring services (CSS) is a fully owned subsidiary of Quintiles Transnational which has been an ally to the biopharmaceutical and medical device industries for more than 28 years. Currently our offices are located in Research Triangle Park, North Carolina, USA, Edinburgh, United Kingdom, Tokyo Japan with core ECG Operations in the Mumbai and Bangalore facilities in India. Project managers operate from the USA, Europe, India, Singapore and Japan. In addition, we have an exclusive team of Japanese speaking project managers who have worked on 150+ trials in Japan. We have managed around trials in 82 different countries for 20 + therapeutic indications. Quintiles cardiac monitoring Services has the unique advantage of being part of a full service CRO organization. By leveraging the resources internally and by holding integrated SOPs across Quintiles service lines, our clients have the advantage of a more unified, efficient approach for their clinical trial. The integrated services offered by Quintiles enable the Sponsor Clinical teams to save time, while ensuring study efficiency and overall success. The Quintiles Clinical, Lab and cardiac monitoring Services Project Managers work together in an integrated fashion throughout the study lifecycle. Some of the efficiencies can be found through the Project Management integrated study practices, including conducting primary integrated study meetings which significantly decreases the amount of meetings the sponsor teams would otherwise need to attend. Since Quintiles has over 100+ office across 60 countries offices worldwide, another key advantage is the ability to leverage the global offices for the customs support when unique cases with remote shipments are required. Having a single, integrated Contract across the services is another key advantage. Our capabilities include: 12-lead digital ECG analysis and interpretation with multiple analysis options: o semi-automated and fully manual methods o measurements of raw beats and Superimposed Median Beat o ECG reporting turnaround timelines of 48hours with express reporting within 30 mins for specific safety indications Cardiac Monitoring: Market and Outsourcing Dynamics 63

64 Service provider capabilities Full QT study capabilities: TQT, intensive QT, SAD MAD and C-QT modeling and simulation Thorough QT analysis per E14 guidelines 12- and 3-lead Holter analysis and interpretation Snapshot ECG extraction and analysis from Holter data set 24/7/365 physician coverage in the ECG lab for site support Paper scan and digitization Along with ECG/Holter centralization, provision of ECG/Holter equipment, training and support to sites Statistical and ECG expert report writing Protocol review and consultation Secure Web portal providing access to standard reports, graphs and charts, data displays and ECG tracings Annotated XML submission in HL7 format to FDA Ambulatory blood pressure monitoring (ABPM) Quintiles has the advantage of the highly skilled and motivated global workforce available, to service the requirements of our customers and respond to the guidelines for cardiac monitoring issued by the FDA regarding QT prolongation. Quintiles cardiac monitoring Services has vast experience in working with many CROs and/or Sponsor teams and follow concise study practices to ensure success. Using the latest software and hardware technology as well as leading IT systems coupled with an enthusiastic and professional workforce ensures our services remain at the cutting-edge of innovation and that we deliver the highest quality of service possible to our customers. In summary, Quintiles CSS is a highly experienced and innovative centralized ECG Core lab offering holistic cardiac monitoring Solutions with centralized Core Lab Services for acquisition and processing of ECG data during Clinical Trials. With state of the art facilities, best in class Cardiologists, strikingly low attrition rate, market leading technologies, strong IT systems, robust DRP and vast experience; Quintiles CSS is well positioned to deliver cost effective and flexible customer solutions for both early and late Phase protocol design, device management, analysis, reporting and regulatory submissions Cardiac Monitoring: Market and Outsourcing Dynamics 64

65 Service provider capabilities Clinical ECG study involvement Quintiles CSS handles over 300 studies at any given time. This includes the entire spectrum of multicentre, multi-country late Phase studies, thorough QT studies, SAD/ MAD Phase I studies, Phase IV post marketing studies and medical device studies. Basic service offerings Assist in protocol design Consulting to determine the appropriate ECG technology and mix Creating the ECG components of regulatory submissions Customer care center Data management Design the standardization approach for reading ECGs across sites Development of ECG acquisition guidelines Development of medical and scientific reports Development of the statistical analysis plan Digital equipment ECG archiving Multilingual Patient Monitoring Regulatory consulting and support Safety report/monitoring Statistical analysis Training of sites Wireless monitoring Integrated Clinical study data (Clinical, Lab, ECG data delivered on a single platform)irb assistance Cardiac Monitoring: Market and Outsourcing Dynamics 65

66 Service provider capabilities Cardiac monitoring service offerings (top 3 bolded) 12-lead ECG analysis: Fully manual 12-lead ECG analysis: Manual 12-lead ECG analysis: Semi-automatic 12-lead ECG analysis: Superimposed median beat ABPM - ambulatory blood pressure monitoring Centralized ECG services Holter for 12-lead ECG collection Holter for arrhythmia analysis TQT Intensive Studies T-wave morphology Therapeutic area coverage (top 3 bolded) Addiction Allergy Cardiology CNS Dermatology Endocrinology Gastroenterology Hematology Immunology Infectious Disease Medical Devices Medical Imaging Metabolic Disease Musculoskeletal Nephrology Neurology Neurophysiology Oncology Ophthalmology Cardiac Monitoring: Market and Outsourcing Dynamics 66

67 Service provider capabilities Pathology Psychiatric Illness Pulmonary/Respiratory Renal Disease Rheumatology Urology Virus/Vaccines Other: Analgesic; Anti-Infectives; Bioavailability; Atomic study Points of differentiation 1. Part of Global CRO with location in 60 countries: Being the only ECG core lab which is a part of a full service CRO allows Quintiles CSS to offer an integrated service offering especially on full service projects with a single data platform that allows a holistic data review to enhance patient safety, improve monitoring efficiency and more complete data for faster decision making. Global reach with respect to Site Setup including machine supply and retrieval in any part of the globe. Quintiles has more than 100 offices across 60 countries around the globe to ensure local support of the sites. Importation and customs are often overlooked in the set up of a global trial and our team is uniquely positioned to support this function. Quintiles CSS has global PM team members located in the United States, Europe, India, Singapore and Japan supporting global multicentre trials. They are supported by a 24X7X365 technical helpdesk and team members directly in the lab at all times. In addition, we have an exclusive team of Japanese speaking project managers who have worked on 150+ trials in Japan 2. Fully Integrated Services: Quintiles cardiac monitoring Services has the unique advantage of being part of a world largest full service CRO organization. By leveraging the resources internally and by holding integrated SOPs across Quintiles service lines, our clients have the advantage of a more unified, efficient approach for their clinical trial. The integrated services offered by Quintiles enable the Sponsor Clinical teams to save time, while ensuring study efficiency and overall success. The Quintiles Clinical, Lab Cardiac Monitoring: Market and Outsourcing Dynamics 67

68 Service provider capabilities and cardiac monitoring Services Project Managers work together in an integrated fashion throughout the study lifecycle. Some of the efficiencies can be found through the Project Management integrated study practices, including conducting primary integrated study meetings which significantly decreases the amount of meetings the sponsor teams would otherwise need to attend. Since Quintiles has over 85 offices worldwide, another key advantage is the ability to leverage the global offices for the customs support when unique cases with remote shipments are required. Having a single, integrated Contract across the services is another key advantage. 3. Consistent High quality Delivery with metrics which constantly exceeds industry standards. Quintiles rigorously monitors and shares with Sponsors performance metrics based on the Industry standards as set forth by the Metrics Champion Consortium (MCC). The metrics are generated and reported to the sponsors periodically and appropriately discussed at various forums based on agreed communication plan with the study teams. Quintiles drives a regular review of the performance metrics, with an eye toward operational transparency so that challenges are identified early and immediate action can be taken towards a proactive process improvement, driving efficiencies with potential cost savings and continuing customer satisfaction. 4. Fastest ECG reporting turnaround in the industry for specific indications Quintiles CSS is currently offering centralized ECG reporting turn-around time of 30 minutes for a group of studies setting a new benchmark in the industry. The team has re-engineered its ECG analysis workflow to successfully deliver on the sponsor s need to comply with the regulatory requirements for cardiac monitoring monitoring 5. Cardiac monitoring Center Of Excellence along with other therapeutic expertise: From protocol review through final data submission, our group of interdisciplinary experts can help you take the right steps to meet your objectives. Our consultative expertise mirrors the Interdisciplinary Review Team of the FDA, applying the same level of scrutiny to your program that you ll face with regulators. 6. Customized solutions Quintiles cardiac monitoring Services offer flexible solutions in order to meet the Cardiac Monitoring: Market and Outsourcing Dynamics 68

69 Service provider capabilities unique requirements of each trial and/or program. This includes solutions across consulting, project management, safety reporting and data management. The cardiac monitoring centre of excellence team provides protocol review and provides consulting for cardiac monitoring methodology, analysis and regulatory reporting. This team works provides consultative expertise which mirrors the Interdisciplinary Review Team of the USFDA applying the same level of scrutiny to a programme. As part of the standard startup plan, Medical and Project Management guidance are available to support the clinical trial process. Safety reporting solutions are customized based on the study design with an integrated workflow which provides instant access to safety data across various stakeholders within a study. Data output and format is discussed with the sponsor teams and customized based on study requirements. 7. Quality focus with pioneering new benchmarks for reader variability assessment: Quintiles established a gold standard in assessing reader variability assessment with the method published in the following peer reviewed journal: (Z-score for benchmarking reader competence in a central ECG laboratory. Ann Noninvasive Electrocardiol Jan;14(1):19-25 Z-score for benchmarking reader competence in a central ECG laboratory. 8. Leading the Science of cardiac monitoring with a Dedicated academic research team This team has published 54 abstract, 23 papers in high impact-factor journals like British Journal of Pharmacology, British Journal of Clinical Pharmacology, Heart Rhythm, American Journal of Therapeutics amongst other, leading the science of cardiac monitoring. Quintiles dedicated team of researchers is actively shaping the science and regulatory landscape, with these publications and has industry standard textbooks to their credit. No other ECG core lab has this many dedicated researchers working to advance the science and methodology of cardiac monitoring every day. Expected company/industry changes Regulatory guidance on alternate TQT strategy FDA Warehouse incorporating full Holter data Request for equipment/supply site details as a result of the Sunshine Act Cardiac Monitoring: Market and Outsourcing Dynamics 69

70 Service provider capabilities Spaulding Clinical Company overview Spaulding Clinical Research, LLC ( a change agent in the clinical research and medical device industries, is focused on driving perpetual value for their clients through technology and process innovation that delivers speed, unprecedented quality and lower costs. Spaulding Clinical Research operates a 105-bed clinical pharmacology unit with 96, 12-lead ECG, telemetry beds in West Bend, Wisconsin, USA. The facility is paperless, using a customized Phase I Electronic Data Capture system with bidirectional interfaces to clinical lab, bedside devices and telemetry. Spaulding Biometrics provides full-service biostatistics, data management and medical writing services. As a Phase I-IV centralized cardiac monitoring provider, Spaulding Clinical offers project management, expert cardiologist ECG over-read and a complete suite of state-of-the-art equipment provisioning, including the Spaulding webecgtm diagnostic 12-lead ECG Management Solution with the purpose-built Spaulding Model 1000iQ Electrocardiograph. The Spaulding cardiac monitoring Advantage is 3 fold cardiac monitoring Expertise, Cloud-based technology to cost-effective centralize the clinical study including a direct interface to Medidata s Clinical Cloud and our Protocol-Driven Process that assures study operational excellence. ACTIVE STUDIES: Spaulding Clinical has a mix of Phase I and global Phase II/III studies at any time. We have grown rapidly over the past 3 years doubling our study numbers every year. Clinical ECG study involvement Spaulding Clinical has a mix of Phase I and global Phase II/III studies at any time. We have grown rapidly over the past 3 years doubling our study numbers every year. Basic service offerings Assist in protocol design Automated platforms Cardiac Monitoring: Market and Outsourcing Dynamics 70

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