IQVIA Holdings Inc. (IQV) 2018年年度報告「NYSE」.pdf

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1、 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington,D.C.20549 FORM 10-K (Mark One)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31,2018 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT

2、 OF 1934 For the transition period from to .Commission File Number:001-35907 IQVIA HOLDINGS INC.(Exact name of registrant as specified in its charter)Delaware(State or other jurisdiction of incorporation or organization)27-1341991(I.R.S.Employer Identification Number)4820 Emperor Blvd.,Durham,North

3、Carolina 27703 and 83 Wooster Heights Road,Danbury,Connecticut 06810(Address of principal executive offices and Zip Code)(919)998-2000 and(203)448-4600(Registrants telephone number,including area code)Securities registered pursuant to Section 12(b)of the Act:Title of Each Class:Name of Each Exchange

4、 on which Registered Common Stock,par value$0.01 per shareNew York Stock ExchangeSecurities registered pursuant to Section 12(g)of the Act:None Indicate by check mark if the registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.Yes No Indicate by check mark if the r

5、egistrant is not required to file reports pursuant to Section 13 or section 15(d)of the Exchange Act.Yes No Indicate by check mark whether the registrant(1)has filed all reports required to be filed by Section 13 or 15(d)of the Securities Exchange Act of 1934 during the preceding twelve months(or fo

6、r such shorter period that the registrant was required to file such reports),and(2)has been subject to such filing requirements for the past 90 days.Yes No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

7、 405 of Regulation S-T(232.405 of this chapter)during the preceding 12 months(or for such shorter period that the registrant was required to submit such files).Yes No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein,and will not

8、 be contained,to the best of registrants knowledge,in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerate

9、d filer,a smaller reporting company,or emerging growth company.See the definitions of“large accelerated filer,”“accelerated filer,”“smaller reporting company,”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filer Accelerated filerNon-accelerated filerSmaller reporting

10、 companyEmerging growth companyIf an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mar

11、k whether the registrant is a shell company(as defined in Rule 12b-2 of the Exchange Act).Yes No The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant,based upon the closing sale price as reported on the New York Stock Exchange on June 29,2018,

12、the last business day of the registrants most recently completed second quarter,was approximately$16.1 billion.Indicate the number of shares outstanding of each of the issuers classes of Common Stock,as of the latest practicable date.Class Number of Shares Outstanding Common Stock$0.01 par value197,

13、599,861 shares outstanding as of February 12,2019Portions of the registrants Proxy Statement for the 2019 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein.Such proxy statement will be filed with the Securit

14、ies and Exchange Commission within 120 days of the registrants fiscal year ended December 31,2018.2IQVIA HOLDINGS INC.FORM 10-K TABLE OF CONTENTS Item PagePART I 1.Business51A.Risk Factors151B.Unresolved Staff Comments372.Properties373.Legal Proceedings374.Mine Safety Disclosures38PART II 5.Market f

15、or Registrants Common Equity,Related Stockholder Matters and Issuer Purchases of Equity Securities396.Selected Financial Data427.Managements Discussion and Analysis of Financial Condition and Results of Operations447A.Quantitative and Qualitative Disclosures About Market Risk648.Financial Statements

16、 and Supplementary Data669.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure1229A.Controls and Procedures1229B.Other Information122PART III 10.Directors,Executive Officers and Corporate Governance12311.Executive Compensation12412.Security Ownership of Certain Benef

17、icial Owners and Management and Related Stockholder Matters12513.Certain Relationships and Related Transactions and Director Independence12514.Principal Accountant Fees and Services125PART IV 15.Exhibits and Financial Statement Schedules126Exhibit Index12716.Form 10-K Summary131Signatures1323FORWARD

18、-LOOKING STATEMENTS Except for any historical information contained herein,the matters discussed or incorporated by reference in this Annual Report on Form 10-K contains forward-looking statements within the meaning of the federal securities laws,including Section 27A of the Securities Act of 1933,a

19、s amended(“Securities Act”),and Section 21E of the Securities Exchange Act of 1934,as amended(the“Exchange Act”).Such forward-looking statements reflect,among other things,our current expectations,our forecasts and our anticipated results of operations,all of which are subject to known and unknown r

20、isks,uncertainties and other factors that may cause our actual results,performance or achievements,market trends,or industry results to differ materially from those expressed or implied by such forward-looking statements.Therefore,any statements contained herein that are not statements of historical

21、 fact may be forward-looking statements and should be evaluated as such.Without limiting the foregoing,the words“anticipates,”“believes,”“estimates,”“expects,”“intends,”“may,”“plans,”“projects,”“should,”“targets,”“will”and the negative thereof and similar words and expressions are intended to identi

22、fy forward-looking statements.These forward-looking statements are subject to a number of risks,uncertainties and assumptions,including those described in Part I,Item 1A,“Risk Factors.”If one or more of these risks or uncertainties materialize,or if underlying assumptions prove incorrect,our actual

23、results may vary materially from those expected,estimated or projected or as otherwise suggested by the forward-looking statements that we make for a number of reasons.Given these uncertainties,users of the information included or incorporated by reference in this Form 10-K,including investors and p

24、rospective investors,are cautioned not to place undue reliance on such forward-looking statements.All forward-looking statements are made only as of the date hereof.We assume no obligation to update any such forward-looking information to reflect actual results or changes in the factors affecting su

25、ch forward-looking information.GENERAL On May 3,2016,Quintiles Transnational Holdings Inc.(“Quintiles”)and IMS Health Holdings,Inc.(“IMS Health”)entered into an Agreement and Plan of Merger(the“Merger Agreement”).Effective October 3,2016,pursuant to the Merger Agreement,IMS Health merged with and in

26、to Quintiles,with Quintiles continuing as the surviving corporation,and the separate corporate existence of IMS Health ceased(the“Merger”).Quintiles was incorporated under the laws of the State of North Carolina on November 10,2009,and immediately prior to the completion of the Merger,Quintiles conv

27、erted to a Delaware corporation and changed its name to QuintilesIMS Holdings,Inc.On November 6,2017,we changed our name to IQVIA Holdings Inc.We renamed two of our reportable segments during the second quarter of 2018.The reportable segment formerly known as Commercial Solutions is now named Techno

28、logy&Analytics Solutions and the reportable segment formerly known as Integrated Engagement Services is now named Contract Sales&Medical Solutions.This is a name change only and there are no changes to the composition of either segment.When we use the terms“IQVIA,”the“Company,”“we,”“us”or“our”in thi

29、s Annual Report on Form 10-K,we mean IQVIA Holdings Inc.and its subsidiaries on a consolidated basis,unless we state or the context implies otherwise.4INDUSTRY AND MARKET DATA This annual report on Form 10-K includes market data and forecasts with respect to the healthcare industry.In some cases,we

30、rely on and refer to market data and certain industry forecasts that were obtained from third party surveys,market research,consultant surveys,publicly available information and industry publications and surveys that we believe to be reliable.However,we have not independently verified data from indu

31、stry analyses and cannot guarantee their accuracy or completeness.We believe that data regarding the industry,market size and its market position and market share within such industry provide general guidance but are inherently imprecise.Other industry and market data included in this annual report

32、are from IQVIA analyses and have been identified accordingly,including,for example,IQVIA Market Prognosis,which is a subscription-based service that provides five-year pharmaceutical market forecasts at the national,regional and global levels.We are a leading global information provider for the heal

33、thcare industry and we maintain databases,produce market analyses and deliver information to clients in the ordinary course of our business.Our information is widely referenced in the industry and used by governments,payers,academia,the life sciences industry,the financial community and others.Most

34、of this information is available on a subscription basis.Other reports and information are available publicly through our IQVIA Institute for Healthcare Informatics(the“IQVIA Institute”).All such information is based upon our own market research,internal databases and published reports and has not b

35、een verified by any independent sources.Our estimates and assumptions involve risks and uncertainties and are subject to change based on various factors,including those discussed in the“Risk Factors”section.These and other factors could cause results to differ materially from those expressed in the

36、estimates and assumptions.TRADEMARKS AND SERVICE MARKS All trademarks,trade names,product names,graphics and logos of IQVIA contained herein are trademarks or registered trademarks of IQVIA Holdings Inc.or its subsidiaries,as applicable,in the United States and/or other countries.All other party tra

37、demarks,trade names,product names,graphics and logos contained herein are the property of their respective owners.The use or display of other parties trademarks,trade names,product names,graphics or logos is not intended to imply,and should not be construed to imply,a relationship with,or endorsemen

38、t or sponsorship of IQVIA Inc.or its subsidiaries by such other party.Solely for convenience,the trademarks,service marks and trade names referred to in this annual report are listed without the,(sm)and(TM)symbols,but we will assert,to the fullest extent under applicable law,our rights or the rights

39、 of the applicable licensors to these trademarks,service marks and trade names.5PART I Item 1.Business Our Company IQVIA is a leading global provider of advanced analytics,technology solutions and contract research services to the life sciences industry.Formed through the Merger of IMS Health and Qu

40、intiles,IQVIA applies human data science leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science to enable companies to reimagine and develop new approaches to clinical development and commercialization,speed innovation,and accelerate improvements in he

41、althcare outcomes.Powered by the IQVIA CORE,we deliver unique and actionable insights at the intersection of large scale analytics,transformative technology and extensive domain expertise as well as execution capabilities to help biotech,medical device,and pharmaceutical companies,medical researcher

42、s,government agencies,payers and other healthcare stakeholders tap into a deeper understanding of diseases,human behaviors and scientific advances,in an effort to advance their path toward cures.With more than 58,000 employees,we conduct operations in more than 100 countries.We have one of the large

43、st and most comprehensive collections of healthcare information in the world,which includes more than 600 million comprehensive,longitudinal,non-identified patient records spanning sales,prescription and promotional data,medical claims,electronic medical records,genomics,and social media.Our scaled

44、and growing data set contains over 30 petabytes of proprietary data sourced from more than 140,000 data suppliers and covering approximately one million data feeds globally.Based on this data,we deliver information and insights on over 85%of the worlds pharmaceuticals,as measured by 2017 sales.We st

45、andardize,curate,structure and integrate this data by applying our sophisticated analytics and leveraging our global technology infrastructure.This helps our clients run their organizations more efficiently and make better decisions to improve their clinical,commercial and financial performance.The

46、breadth of the intelligent,actionable information we provide is not comprehensively available from any other source and our scope of information would be difficult and costly for another party to replicate.We combine our proprietary information assets with advanced analytics,transformative technolog

47、y and domain expertise to develop clinical and commercial capabilities that enable us to grow our relationships with healthcare stakeholders throughout the life sciences value chain.This set of capabilities includes:A leading healthcare-specific global IT infrastructure,representing what we believe

48、is one of the largest and most sophisticated information technology(“IT”)infrastructures in healthcare.We receive over 70 billion healthcare records annually,our infrastructure then connects complex healthcare data while applying a wide range of privacy,security,operational,legal and contractual pro

49、tections for data in response to local law,supplier requirements and industry leading practices;Analytics-driven clinical development,which improves clinical trial design,site identification and patient recruitment by empowering therapeutic,scientific,and domain experts with expansive levels of info

50、rmation,including product level tracking in 90 markets,and information about treatments and outcomes on more than 600 million non-identified patients globally;Robust real-world insights ecosystem,with sophisticated retrospective database analytics,prospective real-world data collection technology pl

51、atforms and scientific expertise,which enables us to address critical healthcare issues of cost,value and patient outcomes;A growing set of proprietary clinical and commercial applications,which helps our clients increase their clinical operations performance,supports their regulatory and compliance

52、 needs and orchestrates their sales operations,sales management,multi-channel marketing and performance management;and A staff of more than 58,000 employees across the globe,including approximately 21,000 Technology&Analytics Solutions employees,approximately 31,000 Research&Development Solutions em

53、ployees and approximately 6,000 Contract Sales&Medical Solutions employees.Integration of information,analytics,technology,and domain expertise through the IQVIA CORE,which enables us to provide our clients with more effective options to address their needs from Research and Development through comm

54、ercialization as well as truly innovative breakthroughs such as virtual trials and global real-world evidence networks.6Our mission-critical relationships with our life science clients consist of four important decision-making processes related to their product portfolios:Research and Development,Pr

55、e-Launch,Launch and In-Market.We continue to develop software and services applications to further deepen our level of client integration by enabling our clients to enhance and/or automate many components of these key decision-making processes.Market opportunity assessment Drug pricing optimization

56、Market access Commercial operations Project management and clinical monitoring Launch readiness Health technology assessment Sales force effectiveness Clinical trial support services Commercial planning Commercial readiness Sales force alignment Patient recruitment Brand positioning Forecasting Mult

57、i-channel marketing Clinical trial laboratory services Message testing Resource allocation Client relationship management Strategic clinical trial planning and design Influence networks Contract sales force Lifecycle management Territory design Observational studies Stakeholder engagementWe believe

58、that a powerful component of our value proposition is the breadth and depth of intelligence we provide to help our clients address fundamental operational questions.UserIllustrative QuestionsResearch&DevelopmentWhich study sites have the target patients?Are there enough patients for my clinical tria

59、l?How long will trial enrollment take to hit target patient volumes?SalesWhich providers generate the highest return on representative visit?Does my sales representative drive appropriate prescribing?How much should I pay my sales representative next month?MarketingWhat share of patients is appropri

60、ately treated?Which underserved patient populations will benefit most from my new drug?Is my brand gaining market share quickly enough to hit revenue forecasts?Real-World Evidence/PharmacovigilanceWhat is the likely impact of new therapies on costs and outcomes?Are new therapies performing better ag

61、ainst existing standards of care in real-world settings?Does real-world data indicate adverse events not detected in clinical trials?7Our Market Opportunity We compete in a market of greater than$230 billion consisting of outsourced research and development,real-world evidence and connected health a

62、nd technology enabled commercial operations markets for life sciences companies and the broader healthcare industry.The following sets forth our estimates for the size of our principal markets:Outsourced research and development:Biopharmaceutical spending on drug development totaled over$100 billion

63、 in 2018.Of that amount,we estimate that our addressable opportunity(clinical development spending excluding preclinical spending)was approximately$66 billion.The portion of this addressable opportunity that was outsourced in 2018,based on our estimates,was approximately$32 billion;Real-World Eviden

64、ce and connected health:Total addressable market of approximately$80 billion based on 2018 sales that consists of two relatively equal parts.First,the market for Real-World Evidence of approximately$40 billion includes traditionally defined analytic platforms and implementation,medical and scientifi

65、c analytic services,observation studies and market access.Second,the market for connected healthcare of approximately$40 billion includes areas such as revenue cycle management,payer analytics and clinical decision support services;and Technology enabled commercial operations:Total addressable marke

66、t of approximately$50 billion based on 2018 sales that includes information,data warehousing,IT outsourcing,software applications and other services in the broader market for IT services.This addressable market also includes commercial services such as recruiting,training,deploying and managing glob

67、al sales forces,channel management,patient engagement services,market access consulting,brand communication,advisory services,and health information analytics and technology consulting.In deriving estimates of the size of the various markets described above,we review third-party sources,which includ

68、e estimates and forecasts of spending in various segments,in combination with internal IQVIA research and analysis informed by our experience serving these segments,as well as projected growth rates for each of these segments.See“Industry and Market Data”above.We believe there are six key trends aff

69、ecting our end markets that will create increasing demand for research and development services and technology&analytics solutions:Growth and innovation in the life sciences industry.The life sciences industry is a large and critical part of the global healthcare system,and,according to the latest i

70、nformation available from the IQVIA Market Prognosis service,is estimated to have generated approximately$1.2 trillion in revenue in 2018.According to our research,revenue growth in the life sciences industry globally is expected to range from 3%to 6%between 2019 and 2023.According to the IQVIA Inst

71、itute,it is estimated that spending on pharmaceuticals in emerging markets will expand at a 5%to 8%compound annual growth rate(“CAGR”)through 2023.The growth of emerging markets is making these geographies strategically important to life sciences organizations and,consistent with their approach in t

72、he developed markets,we expect these organizations to apply a high degree of sophistication to their commercial operations in these countries.For global companies,this requires highly localized knowledge and information assets,the development of market access strategies and performance benchmarking.

73、In addition,local players are learning that they need to compete on the basis of improved information and analytics.Growth in Research and Development.Spending trends in research and development are impacted as a result of several factors,including major biopharmaceutical companies efforts to replen

74、ish revenues lost from the so-called“patent cliff,”increased access to capital by the small and midcap biotechnology industry,and recent increases in pharmaceutical approvals by regulatory authorities.The IQVIA Institute also estimates that approximately 270 new molecular entities(“NMEs”)are expecte

75、d to be approved between 2019 and 2023,compared to 230 between 2014 and 2018,and 182 between 2009 and 2013.We believe that further research and development spending,combined with the continued need for cost efficiency across the healthcare landscape,will continue to create opportunities for biopharm

76、aceutical services companies,particularly those with a global reach and broad service offerings,to help biopharmaceutical companies with their pre-and post-launch solutions development and commercialization needs.8Increased Complexity in Research and Development.Biopharmaceutical companies face envi

77、ronments in which it has become increasingly difficult to operate.Improved standards of care in many therapeutic areas and the emergence of new types of therapies,such as biologics,genetically targeted therapies,gene and stem cell therapies,and other treatment modalities have led to more complex dev

78、elopment and regulatory pathways.For example,the United States and European countries have recently released guidelines for the development of“biosimilar”products.We believe that our global clinical development capabilities,including our expertise in biomarkers and genomics and our global laboratory

79、 network,position us well to help biopharmaceutical companies manage the complexities inherent in an environment where this type of expertise is important.For example,the IQVIA CORE helps us validate protocols to ensure studies in new disease areas have greater accuracy and also enables us,through i

80、nnovations such as predictive analytics,to find patients who may not have been diagnosed.Regulators require clinical trials involving local populations as part of the process for approving new pharmaceutical products,especially in certain Asian and emerging markets.Understanding the epidemiological

81、and physiological differences in different ethnic populations and being able to conduct clinical trials locally in certain geographies will be important to pharmaceutical product growth strategies,both for multinational and local/regional biopharmaceutical companies.We believe that our global clinic

82、al development capabilities and unmatched presence in Asia and other emerging markets make us a strong partner for biopharmaceutical companies managing the complexities of international drug development.Financial pressures driving the need for increased efficiency.Despite expected accelerating growt

83、h in the global life sciences market,we believe our clients will face increased operating margin pressure due to their changing product mix,pricing and reimbursement challenges,and rising costs of compliance.Product portfolios for life sciences companies have shifted toward specialty products with l

84、ower peak market sales potential than traditional primary care medicines.We believe that the need for biopharmaceutical companies to maximize productivity and lower costs across their processes from research and development through commercial operations will cause them to look to partners as they en

85、ter into outsourcing arrangements to improve efficiency.Further,our clients are looking for new ways to simplify processes and drive operational efficiencies by using automation,consolidating vendors and adopting new technology options such as hosted and cloud-based applications.This provides opport

86、unities for technology services vendors to capture and consolidate internal spending by providing lower-cost and variable-cost options that lower clients research and development,selling,marketing and administrative costs.Evolving need to integrate and structure expanding sources of data.Over the pa

87、st decade,many health systems around the world have focused on digitizing medical records.While such records theoretically enhance access to data,relevant information is often unintegrated,unstructured,siloed in disparate software systems,or entered inconsistently.In addition,new sources of data fro

88、m the internet,such as social media and information on limited patient pools,and information resulting from enhanced diagnostic technologies are creating new sources of healthcare data.In order to derive valuable insights from existing and expanding sources of information,clients need access to stat

89、istically significant data sets organized into databases that can be queried and analyzed.For example,real-world evidence studies demonstrate practical and clinical efficacies,which we believe require the aggregation and integration of large clinical data sets across all care settings,types of thera

90、pies and patient cohorts.Longitudinal studies require analysis of non-identified patient diagnoses,treatments,procedures and laboratory test results to identify types of patients that will likely best respond to particular therapies.Finally,manufacturers also require the ability to analyze social me

91、dia activity to identify unmet patient needs and support for new orphan drugs.This information is highly relevant to all healthcare stakeholders and we believe the opportunity to more broadly apply healthcare data can only be realized through structuring,organizing and integrating new and existing f

92、orms of data in conjunction with sophisticated analytics.Need for demonstrated value in healthcare.Participants in the healthcare industry are focused on improving quality and reducing costs,both of which require assessment of quality and value of therapies and providers.As a result,physicians no lo

93、nger make prescribing decisions in isolation,but rather in the context of guidance and rules from payers,integrated delivery networks and governments.We believe life sciences companies are working to bring alignment across constituents on the value of their treatments in order to successfully develo

94、p and commercialize new therapies.There is increasing pressure on life sciences companies to support and justify the value of their therapies.Many new drugs that are being approved are more expensive than existing therapies and will likely receive heightened scrutiny by regulators and payers to dete

95、rmine whether the existing treatment options would be sufficient.Additionally,many new specialty drugs are molecular-based therapies and require a more detailed understanding of clinical factors and influencers that demonstrate therapeutic value.As a result,leading life sciences companies are utiliz

96、ing more sophisticated outcome research and data analytics services.9We believe we are well positioned to take advantage of these global trends in healthcare.Beyond our proprietary information assets,we have developed key capabilities to assess opportunities to develop and commercialize therapies,su

97、pport and defend the value of medicines and help our clients operate more efficiently through the application of insight-driven decision-making and cost-efficient technology solutions.Our Growth Strategy We believe we are well positioned for continued growth across the markets we serve.Our strategy

98、for achieving growth includes:Continue to innovate by leveraging our information,advanced analytics,transformative technology and significant domain expertise.As a leader in the development and commercialization of new pharmaceutical therapies,we can empower our therapeutic,scientific and domain exp

99、erts with expansive levels of information including product level tracking in 90 markets and information about treatments and outcomes on more than 600 million non-identified patients.By integrating these capabilities in the IQVIA CORE,we have the ability to optimize the clinical trial process and e

100、nable our clients to reduce costs and get their products to market more quickly by running their clinical trials more efficiently and effectively through more informed site selection and faster patient recruitment practices as well as through new innovations such as synthetic control arms to better

101、leverage existing data to support future treatments and virtual trials to improve patient centricity.Build upon our extensive client relationships.We have a diversified base of over 8,000 clients in over 100 countries and have expanded our client value proposition to address a broader market for res

102、earch and development and commercial operations which we estimate to be more than$230 billion in 2018.Through the combined offerings of research and development and commercial services we built a platform that allows us to be a more complete partner to our clients.Expand portfolio through strategic

103、acquisitions.We have and expect to continue to acquire assets and businesses that strengthen our value proposition to clients.We have developed an internal capability to source,evaluate and integrate acquisitions that have created value for stockholders.As the global healthcare landscape evolves,we

104、expect that there will be a growing number of acquisition opportunities across the life sciences,payer and provider sectors.We expect to continue to invest in or explore opportunities for strategic acquisitions to grow our platform and enhance our ability to provide more services to our clients.Expa

105、nd the penetration of our offerings to the broader healthcare marketplace.We believe that substantial opportunities exist to expand penetration of our market and further integrate our offerings in a broader cross-section of the healthcare marketplace,particularly connected healthcare.10Our Offerings

106、 We offer hundreds of distinct services,applications,technology platforms and solutions to help our clients make critical decisions and perform better.We have three operating segments:Technology&Analytics Solutions,Research&Development Solutions and Contract Sales&Medical Solutions.Their offerings c

107、omplement each other and can provide enhanced value to our clients when delivered together,with each driving demand for the other.Our Technology&Analytics Solutions offerings include:Technology solutions.We provide an extensive range of cloud-based applications and associated implementation services

108、.Software as a Service(“SaaS”)solutions that support a wide range of clinical and commercial processes,including clinical trial design and planning,site start-up,patient consent,site payments,content management,multi-channel marketing,real-world evidence generation,customer relationship management(“

109、CRM”),performance management,incentive compensation,territory alignment,roster management,call planning,compliance and safety reporting and master data management.These solutions are used by healthcare companies to manage,optimize and execute their clinical and commercial strategies in an orchestrat

110、ed manner while addressing their regulatory obligations.Using proprietary algorithms,we combine our country-level data,healthcare expertise and therapeutic knowledge in over 100 countries to create our Global Market Insight family of offerings such as MIDAS,Analytics Link and Disease Insights,which

111、provides a leading source of insight into international market dynamics and are used by most large pharmaceutical companies.Real-World Insights.We help healthcare stakeholders meet their increasing demand for faster insights and evidence by applying digital technology,scientific expertise,and machin

112、e learning to ever-expanding rich clinical data.We use proprietary patient privacy and security safeguards to protect non-identified patient-level medical claims,prescriptions,electronic medical records,genomics,and social media data.We help our global customers across payers,providers,governments,a

113、nd biopharmaceuticals to answer critical questions about healthcare interventions related to safety,efficacy,and value.We also bring together stakeholders across healthcare to collaborate in efforts to develop new information sources,more effective reimbursement models,and better patient outcomes.An

114、alytics and consulting services.We provide a broad set of strategic and implementation consulting services,including advanced analytics and commercial processes outsourcing services to help the commercial operations of life sciences companies successfully transform their commercial models,engage mor

115、e effectively with the healthcare stakeholders and reduce their operating costs.We also help our clients R&D function to address strategic challenges in the drug development process.Our global teams leverage local market knowledge,deep scientific and therapeutic area expertise and our global informa

116、tion resources to assist our clients with R&D strategy,portfolio,brand and commercial strategy,as well as pricing and market access and launch excellence.National information offerings.Our national offerings comprise unique services in over 90 countries that provide consistent country level performa

117、nce metrics related to sales of pharmaceutical products,prescribing trends,medical treatment and promotional activity across multiple channels including retail,hospital and mail order.These solutions are an integral part of critical processes in life science companies around the world and are also u

118、sed extensively by the investment and financial sectors that deal with life science companies.Sub-national information offerings.Our sub-national offerings comprise unique services in over 70 countries that provide a consistent measurement of sales or prescribing activity at the regional,zip code an

119、d individual prescriber level(depending on regulation in the relevant country).These solutions are used extensively,with a majority of pharmaceutical sales organizations within these countries dependent on these services to set goals,determine resourcing,measure performance and calculate compensatio

120、n.Reference information offerings.Our widely used reference database that tracks approximately 16 million healthcare professionals in over 100 countries,providing a comprehensive view of health care practitioners that is critical for the commercial success of our clients marketing and sales initiati

121、ves.11Our Research&Development Solutions offerings include:Project Management and Clinical Monitoring.Drawing upon our years of experience,our site databases,our site relationships and our highly trained staff,our solutions and services enables the efficient conduct and coordination of multi-site cl

122、inical trials(generally Phase II-IV).Our service offerings include protocol design,feasibility and operational planning,site start up,patient recruitment and clinical site monitoring.By infusing technology into field-based monitoring,we are able to reduce data collection steps and time.Clinical Tria

123、l Support Services.Each clinical trial requires a number of concurrent services and data streams.We offer a broad range of functional services and consultation to support clinical trials through specialized expertise that help clients efficiently collect,analyze and report the quality data and evide

124、nce they need to gain regulatory approval.Q2 Solutions.We provide our clients globally scaled end-to-end clinical trial laboratory and research services through our majority-owned joint venture with Quest Diagnostics Incorporated(“Quest”),which was formed on July 1,2015.We offer genomic and bioanaly

125、tical laboratory services supporting clinical trials offerings within the joint venture,which is referred to as Q2 Solutions.Strategic Planning and Design.By bringing our data science capabilities to our strategic planning and design services,we offer consultation services to improve decisions and p

126、erformance including portfolio,program and protocol planning and design,biomarker consultation,benefit-risk management,regulatory affairs,biostatistics,modeling and simulation,and personalized medicine.Virtual Trials.Utilizing our proprietary information assets and transformative technology,we bring

127、 trials directly to patients,with the objective of increasing participation and improving cycle times.Combining this with purpose-built processes and industry-leading clinical capabilities,we help clients reach diverse and difficult to recruit patient populations.Our principal Contract Sales&Medical

128、 Solutions offerings include:Health Care Provider Engagement Services.We partner with biopharmaceutical companies and other life sciences providers(e.g.,medical device companies)to develop and deploy tailored stakeholder engagement solutions,including contract sales and market access professionals,w

129、hich are focused on improving brand value at all stages of the product lifecycle from initial market entry to brands nearing patent expiry.Patient Engagement Services.Our nurse-based programs directly engage with patients to help improve their disease and medication understanding through interventio

130、nal and non-interventional support,while also providing assistance in navigating complex reimbursement coverage issues.Our patient engagement services combine insight from clinical trials and social listening,behavioral design,personal and innovative eHealth multichannel interactions across multiple

131、 sites(e.g.,the physicians office,hospital,pharmacy,home),that act as an extension of the Health Care Provider prescribed treatment course which can lead to improved adherence and better overall outcomes.Medical Affairs Services.We provide a range of scientific strategy and medical affairs services

132、to help biopharmaceutical companies plan and transition from the clinical trial setting to commercialization.Beginning in the clinical trial stage,our services can deploy educators to clinical trial sites to accelerate patient recruitment and improve retention,assist in translation of complex clinic

133、al trial data into a compelling scientific platform and publication strategy,and,provide field medical teams to facilitate scientific engagement with key opinion leaders and healthcare decision makers,before and after product approval.Our Clients Sales to companies in life sciences,including pharmac

134、eutical companies,biotechnology companies,device and diagnostic companies,and consumer health companies,accounted for the majority of our revenues.Nearly all of the top 100 global pharmaceutical and biotechnology companies,measured by revenue,are clients,and many of these companies subscribe to repo

135、rts and services in many countries.Other clients include payers,government and regulatory agencies,providers,pharmaceutical distributors,and pharmacies.Our client base is broad in scope and enables us to avoid dependence on any single client.No single client accounted for 10%or more of our combined

136、company revenues in 2018,2017 or 2016.12Our Competition Our Technology&Analytics Solutions business competes with a broad and diverse set of businesses.While we believe no competitor provides the combination of geographical reach and breadth of its services,we generally compete in the countries in w

137、hich we operate with other information,analytics,technology,services and consulting companies,as well as with the in-house capabilities of our clients.Also,we compete with certain government agencies,private payers and other healthcare stakeholders that provide their data directly to others.In addit

138、ion to country-by-country competition,we have a number of regional and global competitors in the marketplace as well.Our offerings compete with various firms,including Accenture,Cognizant Technology Solutions,Covance Inc.(the drug development business of Laboratory Corporation of America Holdings),D

139、eloitte,Evidera,GfK,LexisNexis Risk Solutions,IBM,Infosys,Kantar Health,McKinsey,Nielsen,OptumInsight,PAREXEL International Corporation,Press Ganey,RTI Health Solutions,Symphony Health Solutions(now part of PRA Health Sciences),Synovate Healthcare,The Advisory Board,Trizetto,Veeva,Verisk,and ZS Asso

140、ciates.We also compete with a broad range of new entrants and start-ups that are looking to bring new technologies and business models to healthcare information services and technology services.The markets for Research&Development Solutions offerings are highly competitive,and we compete against tra

141、ditional contract research organizations(“CROs”),the in-house research and development departments of biopharmaceutical companies,universities,and teaching hospitals.Among the traditional CROs,there are several-hundred small,limited-service providers,several medium-sized firms and only a few full-se

142、rvice companies with global capabilities.Our primary competitors include Covance Inc.(the drug development business of Laboratory Corporation of America Holdings),ICON plc,PAREXEL International Corporation,Pharmaceutical Product Development,Inc.,PRA Health Sciences,and Syneos Health,among others.Our

143、 Contract Sales&Medical Solutions business competes against the in-house sales and marketing departments of biopharmaceutical companies,other contract pharmaceutical sales and service organizations and consulting firms.Contract Sales&Medical Solutions primary competitor in the United States is Syneo

144、s Health,Publicis and United Drug plc.Outside of the United States,Contract Sales&Medical Solutions typically competes against single country or more regionally focused service providers,such as United Drug plc,Syneos Health,EPS Corporation and CMIC HOLDINGS Co.,Ltd.Government Regulation Many aspect

145、s of our businesses are regulated by federal and state laws,rules and regulations.Accordingly,we maintain a robust compliance program aimed at ensuring we operate our business in compliance with all existing legal requirements material to the operation of our businesses.There are,however,occasionall

146、y uncertainties involving the application of various legal requirements,the violation of which could result in,among other things,fines or other sanctions.See“Part IItem 1ARisk Factors”for additional detail.Good Clinical Practice Good Clinical Practice(“GCP”)regulations and guidelines are the indust

147、ry standard for the conduct of clinical trials with respect to maintaining the integrity of the data and safety of the research subjects.The United States Food and Drug Administration(“FDA”),the European Medicines Agency(“EMA”),Japans Ministry of Health,Labour and Welfare and most other global regul

148、atory authorities expect that study results and data submitted to such authorities be based on clinical trials conducted in accordance with GCP provisions.Records for clinical trials must be maintained for specified periods for inspection by the FDA and other regulators.Regulation of Drugs,Biologics

149、 and Medical Devices In the United States,pharmaceutical,biological and medical device products are subject to extensive regulation by the FDA.The Federal Food,Drug,and Cosmetic Act(“FDC Act”),the Public Health Service Act(“PHS Act”),and other federal and state statutes and regulations,govern,among

150、other things,the research,development,testing,manufacture,storage,recordkeeping,approval,labeling,promotion and marketing,distribution,post-approval monitoring and reporting,sampling,and import and export of pharmaceutical,biological and medical device products.Failure to comply with applicable Unit

151、ed States requirements may subject a company to a variety of administrative or judicial sanctions,such as FDA refusal to approve a pending new drug application(“NDA”)for a new drug,a biologics license application(“BLA”)for a new biological product pre-market approval(“PMA”)or clearance for a new med

152、ical device,warning or untitled letters,clinical holds,product recalls,product seizures,total or partial suspension of production or distribution,injunctions,fines,civil penalties,and criminal prosecution.13Regulation of Patient Information Our information management services relate to the processin

153、g of information regarding patient diagnosis and treatment of disease and are,therefore,subject to substantial governmental regulation.In addition,the confidentiality of patient-specific information and the circumstances under which such patient-specific records may be released for inclusion in our

154、databases or used in other aspects of our business is heavily regulated.Federal,state and foreign governments are contemplating or have proposed or adopted additional legislation governing the possession,use and dissemination of personal data,such as personal health information and personal financia

155、l data,as well as security breach notification rules for loss or theft of such data.Additional legislation or regulation of this type might,among other things,require us to implement additional security measures and processes or bring within the legislation or regulation de-identified health or othe

156、r data,each of which may require substantial expenditures or limit our ability to offer some of our services.In particular,personal health information is recognized in many countries such as the United States,the European Union,or EU,and several countries in Asia,as a special,sensitive category of p

157、ersonal information,subject to additional mandatory protections.Violations of data protection regulations are subject to administrative penalties,civil money penalties and criminal prosecution,including corporate fines and personal liability.Regulation of Promotion,Marketing and Distribution of Phar

158、maceutical Products and Medical Devices Certain of our services are subject to detailed and comprehensive regulation in each geographic market in which we operate.Such regulation relates,among other things,to the distribution of drug samples,the marketing and promotion of approved products,the quali

159、fications of sales representatives and the use of healthcare professionals in sales functions.In the United States,certain of our services are subject to numerous federal and state laws pertaining to promotional activities involving pharmaceutical products and medical devices.Certain of our services

160、 are subject to the FDAs regulations against“off-label promotion,”which require sales representatives to restrict promotion of the approved product they are detailing to the approved labeling for the product.The Prescription Drug Marketing Act imposes licensing,personnel record keeping,packaging,lab

161、eling,product handling and facility storage and security requirements.Other federal and state laws prohibit manufacturers,suppliers and providers from offering,giving or receiving kickbacks or other remuneration in connection with ordering or recommending the purchase or rental of healthcare items a

162、nd services.The sale or distribution of pharmaceutical products and devices is also governed by the United States Federal Trade Commission Act and state consumer protection laws.We are subject to similar regulations currently in effect in the other countries where we offer Contract Sales&Medical Sol

163、utions.We are also subject to various laws and regulations that may apply to certain drug and device promotional practices,including,among others,various aspects of Medicare and federal healthcare programs.Violations of these laws and regulations may result in criminal and/or civil penalties,includi

164、ng possibly as an“aider and abettor.”Regulation of Laboratories Our United States“central”laboratories are subject to licensing and regulation under federal,state and local laws relating to hazard communication and employee right-to-know regulations,and the safety and health of laboratory employees.

165、Additionally,our United States laboratories are subject to applicable federal and state laws and regulations and licensing requirements relating to the handling,storage and disposal of hazardous waste,radioactive materials and laboratory specimens,including the regulations of the Environmental Prote

166、ction Agency,the Nuclear Regulatory Commission,the Department of Transportation,the National Fire Protection Agency and the United States Drug Enforcement Administration(“DEA”).The use of controlled substances in testing for drugs with a potential for abuse is regulated in the United States by the D

167、EA and by similar regulatory bodies in other parts of the world.Our United States laboratories using controlled substances for testing purposes are licensed by the DEA.The regulations of the United States Department of Transportation,Public Health Service and Postal Service apply to the surface and

168、air transportation of laboratory specimens.Our laboratories also are subject to International Air Transport Association regulations,which govern international shipments of laboratory specimens.Furthermore,when the materials are sent to a foreign country,the transportation of such materials becomes s

169、ubject to the laws,rules and regulations of such foreign country.Our laboratories outside the United States are subject to applicable national laws governing matters such as licensing,the handling and disposal of medical specimens,genetic material,hazardous waste and radioactive materials,as well as

170、 the health and safety of laboratory employees.In addition to its comprehensive regulation of safety in the workplace,the United States Occupational Safety and Health Administration has established extensive requirements relating to workplace safety for healthcare employers whose workers may be expo

171、sed to blood-borne pathogens such as HIV and the hepatitis B virus.Although we believe that we are currently in compliance in all material respects with such federal,state and local laws,failure to comply with such laws could subject us to denial of the right to conduct business,fines,criminal penal

172、ties and other enforcement actions.14Further,laboratories that analyze human blood or other biological samples for the diagnosis and treatment of clinical trial subjects must comply with Clinical Laboratory Improvement Amendments(“CLIA”),as well as requirements established by various states.The fail

173、ure to meet these requirements may result in civil penalties and suspension or revocation of the CLIA certification.Our Intellectual Property In addition to our proprietary data sets described above,we develop and use a number of proprietary methodologies,analytics,systems,technologies and other int

174、ellectual property in the conduct of our business.We rely upon a combination of legal,technical,and administrative safeguards to protect our proprietary and confidential information and trade secrets,and patent,copyright and trademark laws to protect other intellectual property rights.We consider ou

175、r trademark and related names,marks and logos to be of material importance to our business,and we have registered or applied for registration for certain of these trademarks including IQVIA,in the United States and other jurisdictions and aggressively seek to protect them.Trademarks and service mark

176、s generally may be renewed indefinitely so long as they are in use and/or their registrations are properly maintained,and so long as they have not been found to have become generic.The technology and other intellectual property rights owned and licensed by us are of importance to our business,althou

177、gh our management believes that our business,as a whole,is not dependent upon any one intellectual property or group of such properties.Our Employees As of December 31,2018,we have more than 58,000 employees worldwide.Almost all of these employees are full-time.None of our employees are covered by a

178、 collective bargaining agreement or are represented by a labor union.Employees in certain locations outside of the United States are represented by works councils as required by local laws.Available Information Our website address is ,and our investor relations website is located at http:/.Informati

179、on on our website is not incorporated by reference herein.Copies of our annual reports on Form 10-K,quarterly reports on Form 10-Q,current reports on Form 8-K and our Proxy Statements for our annual meetings of stockholders,and any amendments to those reports,as well as Section 16 reports filed by o

180、ur insiders,are available free of charge on our website as soon as reasonably practicable after we file the reports with,or furnish the reports to,the Securities and Exchange Commission(“SEC”).In addition,the SEC maintains an Internet site(http:/www.sec.gov)containing reports,proxy and information s

181、tatements,and other information regarding issuers that file electronically with the SEC.Information on the SECs website does not constitute part of this report.Also posted on our website are our certificate of incorporation and by-laws,the charters for our Audit Committee,Leadership Development and

182、Compensation Committee and Nominating and Governance Committee,our Corporate Governance Guidelines,and our Code of Conduct governing our directors,officers and employees.Copies of our SEC reports and corporate governance information are available in print upon the request of any stockholder to our I

183、nvestor Relations Department.Within the time period required by the SEC and the New York Stock Exchange(“NYSE”),we will post on our website any amendment to the Code of Conduct or any waiver of such policy applicable to any of our senior financial officers,executive officers or directors.15 Item 1A.

184、Risk Factors RISK FACTORSWe operate in a rapidly changing environment that involves a number of risks,some of which are beyond our control.You should consider carefully the risks and uncertainties described below together with the other information included in this Annual Report on Form 10-K,includi

185、ng our consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K,in evaluating our company.The occurrence of any of the following risks may materially and adversely affect our business,financial condition,results of operations and future prospects.Risk

186、s Relating to Our Business The potential loss or delay of our large contracts or of multiple contracts could adversely affect our results.Most of our Research&Development Solutions clients can terminate our contracts upon 30 to 90 days notice.Our clients may delay,terminate or reduce the scope of ou

187、r contracts for a variety of reasons beyond our control,including but not limited to:decisions to forego or terminate a particular clinical trial;lack of available financing,budgetary limits or changing priorities;actions by regulatory authorities;production problems resulting in shortages of the dr

188、ug being tested;failure of products being tested to satisfy safety requirements or efficacy criteria;unexpected or undesired clinical results for products;insufficient patient enrollment in a clinical trial;insufficient investigator recruitment;shift of business to a competitor or internal resources

189、;product withdrawal following market launch;or shut down of manufacturing facilities.As a result,contract terminations,delays and alterations are a regular part of our Research&Development Solutions business.In the event of termination,our contracts often provide for fees for winding down the projec

190、t,but these fees may not be sufficient for us to maintain our margins,and termination may result in lower resource utilization rates.In addition,we will not realize the full benefits of our backlog of contractually committed services if our clients cancel,delay or reduce their commitments under our

191、contracts with them,which may occur if,among other things,a client decides to shift its business to a competitor or revoke our status as a preferred provider.Thus,the loss or delay of a large contract or the loss or delay of multiple contracts could adversely affect our revenues and profitability.We

192、 believe the risk of loss or delay of multiple contracts potentially has greater effect where we are party to broader partnering arrangements with global biopharmaceutical companies.16 We depend on third parties for data and support services.Our suppliers or providers might restrict our use of or re

193、fuse to license data or provide services,which could lead to our inability to access certain data or provide certain services and,as a result,materially and adversely affect our operating results and financial condition.Each of our Technology&Analytics Solutions information services is derived from

194、data we collect from third parties.These data suppliers are numerous and diverse,reflecting the broad scope of information that we collect and use in our business.Although we typically enter into long-term contractual arrangements with many of these suppliers of data,at the time of entry into a new

195、contract or renewal of an existing contract,suppliers may increase restrictions on our use of such data,increase the price they charge us for data or refuse altogether to license the data to us.In addition,during the term of any data supply contract,suppliers may fail to adhere to our data quality c

196、ontrol standards or fail to deliver data.Further,although no single individual data supplier is material to our business,if a number of suppliers collectively representing a significant amount of data that we use for one or more of our services were to impose additional contractual restrictions on o

197、ur use of or access to data,fail to adhere to our quality-control standards,repeatedly fail to deliver data or refuse to provide data,now or in the future,our ability to provide those services to our clients could be materially adversely impacted,which may harm our operating results and financial co

198、ndition.Additionally,we depend on third parties for support services to our business.Such support services include,but are not limited to,third-party transportation providers,suppliers of drugs for patients participating in clinical trials,suppliers of kits for use in our clinical trial laboratories

199、 business,suppliers of reagents for use in our testing equipment and providers of maintenance contracts for our equipment.The failure of any of these third parties to adequately provide the critical support services could have a material adverse effect on our business.If we fail to perform our servi

200、ces in accordance with contractual requirements,regulatory standards and ethical considerations,we could be subject to significant costs or liability and our reputation could be harmed.We contract with biopharmaceutical companies to perform a wide range of services to assist them in bringing new dru

201、gs to market.Our services include monitoring clinical trials,data and laboratory analysis,electronic data capture,patient recruitment and other related services,and we perform these services in a number of ways,including through physical and technology-enabled efforts.Such services are complex and s

202、ubject to contractual requirements,regulatory standards and ethical considerations.For example,we must adhere to regulatory requirements such as the FDA and current GCP and Good Laboratory Practice requirements.If we fail to perform our services in accordance with these requirements,regulatory agenc

203、ies may take action against us for failure to comply with applicable regulations governing clinical trials or sales and marketing practices.Such actions may include sanctions,such as injunctions or failure of such regulatory authorities to grant marketing approval of products,delay,suspension or wit

204、hdrawal of approvals,license revocation,product seizures or recalls,operational restrictions,civil or criminal penalties or prosecutions,damages or fines.Clients may also bring claims against us for breach of our contractual obligations and patients in the clinical trials and patients taking drugs a

205、pproved on the basis of those clinical trials may bring personal injury claims against us for negligence.Any such action could have a material adverse effect on our results of operations,financial condition and reputation.Such consequences could arise if,among other things,the following occur:Improp

206、er performance of our services.The performance of clinical development services is complex and time-consuming.For example,we may make mistakes in conducting a clinical trial that could negatively impact or obviate the usefulness of the clinical trial or cause the results of the clinical trial to be

207、reported improperly.If the clinical trial results are compromised,we could be subject to significant costs or liability,which could have an adverse impact on our ability to perform our services.As examples:non-compliance generally could result in the termination of ongoing clinical trials or sales a

208、nd marketing projects or the disqualification of data for submission to regulatory authorities;compromise of data from a particular clinical trial,such as failure to verify that informed consent was obtained from patients,could require us to repeat the clinical trial under the terms of our contract

209、at no further cost to our client,but at a substantial cost to us;and breach of a contractual term could result in liability for damages or termination of the contract.Large clinical trials can cost up to hundreds of millions of dollars,and while we endeavor to contractually limit our exposure to suc

210、h risks,improper performance of our services could have an adverse effect on our financial condition,damage our reputation and result in the cancellation of current contracts by or failure to obtain future contracts from the affected client or other clients.17Investigation of clients.From time to ti

211、me,one or more of our clients are audited or investigated by regulatory authorities or enforcement agencies with respect to regulatory compliance of their clinical trials,programs or the marketing and sale of their drugs.In these situations,we have often provided services to our clients with respect

212、 to the clinical trials,programs or activities being audited or investigated,and we are called upon to respond to requests for information by the authorities and agencies.There is a risk that either our clients or regulatory authorities could claim that we performed our services improperly or that w

213、e are responsible for clinical trial or program compliance.If our clients or regulatory authorities make such claims against us and prove them,we could be subject to damages,fines or penalties.In addition,negative publicity regarding regulatory compliance of our clients clinical trials,programs or d

214、rugs could have an adverse effect on our business and reputation.Insufficient client funding to complete a clinical trial.As noted above,clinical trials can cost hundreds of millions of dollars.There is a risk that we may initiate a clinical trial for a client,and then the client becomes unwilling o

215、r unable to fund the completion of the clinical trial.In such a situation,notwithstanding the clients ability or willingness to pay for or otherwise facilitate the completion of the clinical trial,we may be ethically bound to complete or wind down the clinical trial at our own expense.Security breac

216、hes and unauthorized use of our IT systems and information,or the IT systems or information in the possession of our vendors,could expose us,our clients,our data suppliers or others to risk of loss.We rely upon the security of our computer and communications systems infrastructure to protect us from

217、 cyberattacks and unauthorized access.Cyberattacks can include malware,computer viruses,hacking or other significant disruption of our computer,communications and related systems.Cyber threats are rapidly evolving and are becoming increasingly sophisticated.Despite our efforts to ensure the integrit

218、y of our systems,as cyber threats evolve and become more difficult to detect and successfully defend against,one or more cyber threats might defeat the measures that we or our vendors take to anticipate,detect,avoid or mitigate such threats.Certain techniques used to obtain unauthorized access,intro

219、duce malicious software,disable or degrade service,or sabotage systems may be designed to remain dormant until a triggering event and we may be unable to anticipate these techniques or implement adequate preventative measures since techniques change frequently or are not recognized until launched,an

220、d because cyberattacks can originate from a wide variety of sources.Although we take steps to manage and avoid these risks and to prevent their recurrence,our preventive and remedial actions may not be successful.Such attacks,whether successful or unsuccessful,could result in our incurring costs rel

221、ated to,for example,rebuilding internal systems,defending against litigation,responding to regulatory inquiries or actions,paying damages or fines,or taking other remedial steps with respect to third parties.Publicity about vulnerabilities and attempted or successful incursions could damage our repu

222、tation with clients and data suppliers and reduce demand for our services.We also store proprietary and sensitive information in connection with our business,which could be compromised by a cyberattack.To the extent that any disruption or security breach results in a loss or damage to our data,an in

223、appropriate disclosure of proprietary or sensitive information,an inability to access data sources,or an inability to process data or provide our offerings to our clients,it could cause significant damage to our reputation,affect our relationships with our data suppliers and clients(including loss o

224、f suppliers and clients),lead to claims against us and ultimately harm our business.We may be required to incur significant costs to alleviate,remedy or protect against damage caused by these disruptions or security breaches in the future.We may also face inquiry or increased scrutiny from governmen

225、t agencies as a result of any such disruption or breach.While we have insurance coverage for certain instances of a cyber security breach,our coverage may not be sufficient if we suffer a significant attack or multiple attacks.Any such breach or disruption could have a material adverse effect on our

226、 operating results and our reputation as a provider of mission-critical services.Some of our vendors have significant responsibility for the security of certain of our data centers and computer-based platforms.Also,our data suppliers have responsibility for security of their own computer and communi

227、cations environments.These third parties face risks relating to cyber security similar to ours,which could disrupt their businesses and therefore materially impact ours.Accordingly,we are subject to any flaw in or breaches to their computer and communications systems or those that they operate for u

228、s,which could result in a material adverse effect on our business,operations and financial results.Failure to meet productivity objectives under our internal business transformation initiatives could adversely impact our competitiveness and harm our operating results.We are pursuing business transfo

229、rmation initiatives to update technology,increase innovation and obtain operating efficiencies.As part of these initiatives,we seek to improve our productivity,flexibility,quality,functionality and cost savings by investing in the development and implementation of global platforms and integration of

230、 our business processes and functions to achieve economies of scale.For example,we are evaluating our site activation processes and procedures,including technology enablement platforms,and implementing changes to accelerate site start-up timelines and provide greater transparency to clients and inve

231、stigator sites.These various initiatives may not yield their intended gains,or be completed in timely manner,which may impact our competitiveness and our ability to meet our growth objectives and,as a result,materially and adversely affect our business,operating results and financial condition.18If

232、we are unsuccessful at investing in growth opportunities,our business could be materially and adversely affected.We continue to invest significantly in growth opportunities,including the development and acquisition of new data,technologies and services to meet our clients needs.For example,we are ex

233、panding our services and technology offerings,such as the development of a cloud-based platform with a growing number of applications to support commercial operations for life sciences companies(e.g.,multi-channel marketing,marketing campaign management,customer relationship management,incentive com

234、pensation management,targeting and segmentation,performance management and other applications).We also continue to invest significantly in growth opportunities in emerging markets,such as the development,launch and enhancement of services in China,India,Russia,Turkey,and other countries.We believe h

235、ealthcare spending in these emerging markets will continue to grow over the next five years,and we consider our presence in these markets to be an important focus of our growth strategy.There is no assurance that our investment plans or growth strategy will be successful or will produce a sufficient

236、 or any return on our investments.Further,if we are unable to develop new technologies and services,clients do not purchase our new technologies and services,our new technologies and services do not work as intended or there are delays in the availability or adoption of our new technologies and serv

237、ices,then we may not be able to grow our business or growth may occur slower than anticipated.Additionally,although we expect continued growth in healthcare spending in emerging markets,such spending may occur more slowly or not at all,and we may not benefit from our investments in these markets.We

238、plan to fund growth opportunities with cash from operations or from future financings.There can be no assurance that those sources will be available in sufficient amounts to fund future growth opportunities when needed.Any of the foregoing could have a material and adverse effect on our operating re

239、sults and financial condition.Data protection,privacy and similar laws in the United States and around the world restrict access,use and disclosure of personal information,and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.The confidentialit

240、y,collection,use and disclosure of personal data,including individually identifiable health information and clinical trial patient-specific information,are subject to governmental regulation generally in the country that the personal data were collected or used.For example,United States federal regu

241、lations under the Health Insurance Portability and Accountability Act of 1996(“HIPAA”)create specific requirements for the protection of the privacy and security of individual health information.These provisions apply to both“covered entities”(primarily health care providers and health insurers)and

242、their“business associates”or service providers.As there are some instances where we are a HIPAA“business associate”of a“covered entity,”we can be directly liable for mishandling protected health information.Under HIPAAs enforcement scheme,we can be subject to significant penalties in connection with

243、 HIPAA violations,along with the potential for significant other expenditures related to these activities.These rules require individuals written authorization in many situations,in addition to any required informed consent,before protected health information may be used for research.We are both dir

244、ectly and indirectly affected by the privacy provisions surrounding individual authorizations because many investigators with whom we are involved in clinical trials are directly subject to them as a HIPAA“covered entity”and because we obtain identifiable health information from third parties that a

245、re subject to such regulations.The laws and regulations related to the protection of personal health information in connection with research activities are under re-evaluation,particularly in the United States,and changes to these regulations could have a material adverse impact on our ability to pr

246、ovide some of our services in their current form or maintain our profitability.In general,patient health information is among the most sensitive(and highly regulated)of personal information and laws and regulations around the United States and the world are designed to ensure that information about

247、an individuals healthcare is properly protected from inappropriate access,use and disclosure.Laws restricting access,use and disclosure of patient health information also include the European Unions(“EU”)General Data Protection Regulation,Canadas Personal Information Protection and Electronic Docume

248、nts Act and other data protection,privacy,data security and similar national,state/provincial and local laws.In the EU personal data includes any information that relates to an identified or identifiable natural person with health information carrying additional obligations,including obtaining the e

249、xplicit consent from the individual for collection,use or disclosure of the information.In addition,we are subject to EU rules with respect to cross-border transfers of such data out of the EU(along with similar data transfer requirements in other countries).The United States,the EU and its member s

250、tates,and other countries where we have operations,such as China,Japan,Malaysia,Philippines,Russia,South Korea and Singapore,continue to issue new privacy and data protection rules and regulations that relate to personal data and health information.19We have established frameworks,models,processes a

251、nd technologies to manage privacy and security for many data types,from a variety of sources,and under myriad privacy and data protection laws worldwide.In addition,we rely on our data suppliers to deliver information to us in a form and in a manner that complies with applicable privacy and data pro

252、tection laws.These laws are complex and there is no assurance that the safeguards and controls employed by us or our data suppliers will be sufficient to prevent a breach of these laws,or that claims will not be filed against us or our data suppliers despite such safeguards and controls.Failure to c

253、omply with such laws,certain certification/registration and annual re-certification/registration provisions associated with these data protection and privacy regulations,and similar rules in various jurisdictions,or to resolve any serious privacy complaints,may result in,among other things,regulator

254、y sanctions,criminal prosecution,civil liability,negative publicity,damage to our reputation,or data being blocked from use or liability under contractual provisions.For example,in July 2015,indictments were issued by the Seoul Central District Prosecutors Office in South Korea against IMS Korea and

255、 two of its employees,among others,alleging improper handling of sensitive health information in violation of applicable privacy laws.See Item 3“Legal Proceedings”for additional information.Laws and expectations relating to privacy continue to evolve,and we continue to adapt to changing needs.For ex

256、ample,the definition of“personally identifiable information”and“personal data”continues to evolve and broaden and many new laws and regulations are being enacted.In addition,certain long-established programs have been(or are at risk of being)declared invalid(such as the EU-U.S.Safe Harbor framework

257、that operated for many years but was struck down by European courts in 2015),so that this area remains in a state of flux.Changes to these programs may adversely impact our ability to provide services to our clients or develop new products or services.Federal,state and foreign governments are contem

258、plating or have proposed or adopted additional legislation governing the collection,possession,use or dissemination of personal data,such as personal health information,and personal financial data as well as security breach notification rules for loss or theft of such data.Additional legislation or

259、regulation of this type might,among other things,require us to implement new security measures and processes or bring within the legislation other personal data not currently regulated,each of which may require substantial expenditures or limit our ability to offer some of our services.Additionally,

260、changes in these laws(including newly released interpretations of these laws by courts and regulatory bodies)may limit our data access,use and disclosure,and may require increased expenditures by us or may dictate that we not offer certain types of services.Any of the foregoing may have a material a

261、dverse impact on our ability to provide services to our clients or maintain our profitability.There is ongoing concern from privacy advocates,regulators and others regarding data protection and privacy issues,and the number of jurisdictions with data protection and privacy laws has been increasing.A

262、lso,there are ongoing public policy discussions regarding whether the standards for de-identified,anonymous or pseudonymized health information are sufficient,and the risk of re-identification sufficiently small,to adequately protect patient privacy.These discussions may lead to further restrictions

263、 on the use of such information.There can be no assurance that these initiatives or future initiatives will not adversely affect our ability to access and use data or to develop or market current or future services.Data protection,privacy and similar laws protect more than patient information,and al

264、though they vary by jurisdiction,these laws can extend to employee information,business contact information,provider information and other information relating to identifiable individuals.Failure to comply with these laws may result in,among other things,civil and criminal liability,negative publici

265、ty,damage to our reputation and liability under contractual provisions.In addition,compliance with such laws may require increased costs to us or may dictate that we not offer certain types of services.The occurrence of any of the foregoing could impact our ability to provide the same level of servi

266、ce to our clients,require us to modify our offerings or increase our costs,which could materially and adversely affect our operating results and financial condition.Our success depends on our ability to protect our intellectual property rights.Our success depends,in part,upon our ability to develop,

267、use and protect our proprietary methodologies,analytics,systems,technologies and other intellectual property.Existing laws of the various countries in which we provide services or solutions offer only limited protection of our intellectual property rights,and the protection in some countries may be

268、very limited.We rely upon a combination of trade secrets,confidentiality policies,nondisclosure,invention assignment and other contractual arrangements,and patent,copyright and trademark laws,to protect our intellectual property rights.These laws are subject to change at any time and certain agreeme

269、nts may not be fully enforceable,which could further restrict our ability to protect our innovations.Our intellectual property rights may not prevent competitors from independently developing services similar to or duplicative of ours.Further,the steps we take in this regard might not be adequate to

270、 prevent or deter infringement or other misappropriation of our intellectual property by competitors,former employees or other third parties,and we might not be able to detect unauthorized use of,or take appropriate and timely steps to enforce,our intellectual property rights.20 Our ability to obtai

271、n,protect and enforce our intellectual property rights is subject to general litigation or third-party opposition risks,as well as the uncertainty as to the scope of protection,registrability,patentability,validity and enforceability of our intellectual property rights in each applicable country.Gov

272、ernments may adopt regulations,and government agencies or courts may render decisions,requiring compulsory licensing of intellectual property rights.When we seek to enforce our intellectual property rights we may be subject to claims that the intellectual property rights are invalid or unenforceable

273、.Litigation may be necessary in the future to enforce our intellectual property rights and to protect our confidential and proprietary information.Litigation brought to protect and enforce our intellectual property rights could be costly,time consuming and distracting to management and could result

274、in the impairment or loss of portions of our intellectual property rights.Furthermore,our efforts to enforce our intellectual property rights may be met with defenses,counterclaims and countersuits attacking the validity and enforceability of our intellectual property rights.Our inability to protect

275、 our proprietary technology against unauthorized copying or use,as well as any costly litigation or diversion of our managements attention and resources,could delay further sales or the implementation of our solutions,impair the functionality of our solutions,delay introductions of new solutions,res

276、ult in our substituting inferior or more costly technologies into our solutions,or injure our reputation and harm our operating results and financial condition.The theft or unauthorized use or publication of our trade secrets and other confidential business information could reduce the differentiati

277、on of our services and harm our business;the value of our investment in development or business acquisitions could be reduced;and third parties might make claims against us related to losses of their confidential or proprietary information.In addition,we may not be able to discover or determine the

278、extent of any unauthorized use of our proprietary rights.Third parties that license our proprietary rights also may take actions that diminish the value of our proprietary rights or reputation.The protection of our intellectual property may require the expenditure of significant financial and manage

279、rial resources.Moreover,the steps we take to protect our intellectual property may not adequately protect our rights or prevent third parties from infringing or misappropriating our proprietary rights.These incidents and claims could harm our business,reduce revenue,increase expenses and harm our re

280、putation.We may be subject to claims by others that we are infringing on their intellectual property rights.Third parties may assert claims that we or our clients infringe their intellectual property rights and these claims,with or without merit,could be expensive to litigate,cause us to incur subst

281、antial costs and divert management resources and attention in defending the claim.In some jurisdictions,plaintiffs can also seek injunctive relief that may limit the operation of our business or prevent the marketing and selling of our services that infringe on the plaintiffs intellectual property r

282、ights.To resolve these claims,we may enter into licensing agreements with restrictive terms or significant fees,stop selling,be required to implement costly redesigns to the affected services,or pay damages to satisfy contractual obligations to others.If we do not resolve these claims in advance of

283、a trial,there is no guarantee that we will be successful in court.These outcomes may have a material adverse impact on our business,operating results and financial condition.In addition,certain contracts with our suppliers or clients contain provisions whereby we indemnify,subject to certain limitat

284、ions,the counterparty for damages suffered as a result of claims related to intellectual property infringement and the use of data.Claims made under these provisions could be expensive to litigate and could result in significant payments.We rely on licenses from third parties to certain technology a

285、nd intellectual property rights for some of our services and the licenses we currently have could terminate or expire.Some of our business services rely on technology or intellectual property rights owned and controlled by others.Our licenses to this technology or these intellectual property rights

286、could be terminated or could expire.We may be unable to replace these licenses in a timely manner.Failure to renew these licenses,or renewals of these licenses on less advantageous terms,could harm our operating results and financial condition.Our financial results may be adversely affected if we un

287、derprice our contracts,overrun our cost estimates or fail to receive approval for or experience delays in documenting change orders.Most of our Research&Development Solutions contracts are either fee for service contracts or fixed-fee contracts.Our past financial results have been,and our future fin

288、ancial results may be,adversely impacted if we initially underprice our contracts or otherwise overrun our cost estimates and are unable to successfully negotiate a change order.Change orders typically occur when the scope of work we perform needs to be modified from that originally contemplated by

289、our contract with the client.Modifications can occur,for example,when there is a change in a key clinical trial assumption or parameter or a significant change in timing.Where we are not successful in converting out-of-scope work into change orders under our current contracts,we bear the cost of the

290、 additional work.Such underpricing,significant cost overruns or delay in documentation of change orders could have a material adverse effect on our business,results of operations,financial condition or cash flows.21The relationship of backlog to revenues varies over time.Backlog represents future re

291、venues for our Research&Development Solutions business from work not yet completed or performed under signed binding commitments and signed contracts.Once work begins on a project,revenue is recognized over the duration of the project.Projects may be terminated or delayed by the client or delayed by

292、 regulatory authorities for reasons beyond our control.To the extent projects are delayed,the timing of our revenue could be affected.In the event that a client cancels a contract,we typically would be entitled to receive payment for all services performed up to the cancellation date and subsequent

293、client-authorized services related to terminating the canceled project.Typically,however,we have no contractual right to the full amount of the revenue reflected in our backlog in the event of a contract cancellation.The duration of the projects included in our backlog,and the related revenue recogn

294、ition,range from a few weeks to many years.Our backlog may not be indicative of our future revenues from our Research&Development Solutions business,and we may not realize all the anticipated future revenue reflected in our backlog.A number of factors may affect backlog,including:the size,complexity

295、 and duration of the projects;the percentage of full services versus functional services;the cancellation or delay of projects;and change in the scope of work during the course of a project.Although an increase in backlog will generally result in an increase in revenues to be recognized over time(de

296、pending on the level of cancellations),an increase in backlog at a particular point in time does not necessarily correspond directly to an increase in revenues during a particular period.The extent to which contracts in backlog will result in revenue depends on many factors,including but not limited

297、 to delivery against projected schedules,the need for scope changes(change orders),contract cancellations and the nature,duration,size,complexity and phase of the contracts,each of which factors can vary significantly from time to time.The rate at which our backlog converts to revenue may vary over

298、time for a variety of reasons.The revenue recognition on larger,more global projects could be slower than on smaller,less global projects for a variety of reasons,including but not limited to an extended period of negotiation between the time the project is awarded to us and the actual execution of

299、the contract,as well as an increased timeframe for obtaining the necessary regulatory approvals.Additionally,the increased complexity of clinical trials and the need to enroll precise patient populations could extend the length of clinical trials causing revenue to be recognized over a longer period

300、 of time.Further,delayed projects will remain in backlog,unless otherwise canceled by the client,and will not generate revenue at the rate originally expected.Thus,the relationship of backlog to realized revenues may vary over time.Our business depends on the continued effectiveness and availability

301、 of our information systems,including the information systems we use to provide our services to our clients,and failures of these systems may materially limit our operations.Due to the global nature of our business and our reliance on information systems to provide our services,we intend to increase

302、 our use of web-enabled and other integrated information systems in delivering our services.We also provide access to similar information systems to certain of our clients in connection with the services we provide them.As the breadth and complexity of our information systems continue to grow,we wil

303、l increasingly be exposed to the risks inherent in the development,integration and ongoing operation of evolving information systems,including:disruption,impairment or failure of data centers,telecommunications facilities or other key infrastructure platforms;security breaches of,cyberattacks on and

304、 other failures or malfunctions in our critical application systems or their associated hardware;and excessive costs,excessive delays or other deficiencies in systems development and deployment.22The materialization of any of these risks may impede the processing of data,the delivery of databases an

305、d services,and the day-to-day management of our business and could result in the corruption,loss or unauthorized disclosure of proprietary,confidential or other data.While we have disaster recovery plans in place,they might not adequately protect us in the event of a system failure.While many of our

306、 operations have disaster recovery plans in place,we currently do not have excess or standby computer processing or network capacity everywhere in the world to avoid disruption in the receipt,processing and delivery of data in the event of a system failure.Despite any precautions we take,damage from

307、 fire,floods,hurricanes,power loss,telecommunications failures,computer viruses,break-ins and similar events at our various computer facilities could result in interruptions in the flow of data to our servers and from our servers to our clients.Corruption or loss of data may result in the need to re

308、peat a clinical trial at no cost to the client,but at significant cost to us,the termination of a contract or damage to our reputation.In addition,any failure by our computer environment to provide sufficient processing or network capacity to transfer data could result in interruptions in our servic

309、e.In the event of a delay in the delivery of data,we could be required to transfer our data collection operations to an alternative provider of server hosting services.Such a transfer could result in significant delays in our ability to deliver services to our clients and increase our costs.Addition

310、ally,significant delays in system enhancements or inadequate performance of new or upgraded systems once completed could damage our reputation and harm our business.Finally,long-term disruptions in the infrastructure caused by events such as natural disasters,the outbreak of war,the escalation of ho

311、stilities and acts of terrorism,particularly involving cities in which we have offices,could adversely affect our businesses.Although we carry property and business interruption insurance,our coverage might not be adequate to compensate us for all losses that may occur.We have continued to undertake

312、 significant programs to optimize business processes with respect to our services.Our inability to effectively manage the implementation and adapt to new processes designed into new or upgraded systems in a timely and cost-effective manner may result in disruption to our business and negatively affe

313、ct our operations.We have entered into agreements with certain vendors to provide systems development and integration services that develop or license to us the IT platform for programs to optimize our business processes.If such vendors fail to perform as required or if there are substantial delays

314、in developing,implementing and updating the IT platform,our client delivery may be impaired,and we may have to make substantial further investments,internally or with third parties,to achieve our objectives.Additionally,our progress may be limited by parties with existing or claimed patents who seek

315、 to enjoin us from using preferred technology or seek license payments from us.Meeting our objectives is dependent on a number of factors which may not take place as we anticipate,including obtaining adequate technology-enabled services,creating IT-enabled services that our clients will find desirab

316、le and implementing our business model with respect to these services.Also,increased IT-related expenditures may negatively impact our profitability.We may experience challenges with the acquisition,development,enhancement or deployment of technology necessary for our business.We operate in business

317、es that require sophisticated computer systems and software for data collection,data processing,cloud-based platforms,analytics,cryptography,statistical projections and forecasting,mobile computing,social media analytics and other applications and technologies,particularly in our Technology&Analytic

318、s Solutions and Research&Development Solutions businesses.We seek to address our technology risks by increasing our reliance on the use of innovations by cross-industry technology leaders and adapt these for our biopharmaceutical and healthcare industry clients.Some of these technologies supporting

319、the industries we serve are changing rapidly and we must continue to adapt to these changes in a timely and effective manner at an acceptable cost.We also must continue to deliver data to our clients in forms that are easy to use while simultaneously providing clear answers to complex questions.Ther

320、e can be no guarantee that we will be able to develop,acquire or integrate new technologies,that these new technologies will meet our clients needs or achieve expected investment goals,or that we will be able to do so as quickly or cost-effectively as our competitors.Significant technological change

321、 could render certain of our services obsolete.Moreover,the introduction of new services embodying new technologies could render certain of our existing services obsolete.Our continued success will depend on our ability to adapt to changing technologies,manage and process ever-increasing amounts of

322、data and information and improve the performance,features and reliability of our services in response to changing client and industry demands.We may experience difficulties that could delay or prevent the successful design,development,testing,introduction or marketing of our services.New services,or

323、 enhancements to existing services,may not adequately meet the requirements of current and prospective clients or achieve any degree of significant market acceptance.These types of failures could have a material adverse effect on our operating results and financial condition.23Consolidation in the i

324、ndustries in which our clients operate may reduce the volume of services purchased by consolidated clients following an acquisition or merger,which could materially harm our operating results and financial condition.Mergers or consolidations among our clients have in the past and could in the future

325、 reduce the number of our clients and potential clients.When companies consolidate,overlapping services previously purchased separately are usually purchased only once by the combined entity,leading to loss of revenue.Other services that were previously purchased by one of the merged or consolidated

326、 entities may be deemed unnecessary or cancelled.If our clients merge with or are acquired by other entities that are not our clients,or that use fewer of our services,they may discontinue or reduce their use of our services.There can be no assurance as to the degree to which we may be able to addre

327、ss the revenue impact of such consolidation.Any of these developments could materially harm our operating results and financial condition.We may be adversely affected by client or therapeutic concentration.Although we did not have any client that represented 10%or more of our revenues in 2018,2017 a

328、nd 2016,we derive the majority of our revenues from a number of large clients.If any large client decreases or terminates its relationship with us,our business,results of operations or financial condition could be materially adversely affected.Additionally,conducting multiple clinical trials for dif

329、ferent clients in a single therapeutic class involving drugs with the same or similar chemical action has in the past and may in the future adversely affect our business if some or all of the clinical trials are canceled because of new scientific information or regulatory judgments that affect the d

330、rugs as a class or if industry consolidation results in the rationalization of drug development pipelines.Similarly,marketing and selling drugs for different biopharmaceutical companies with similar chemical actions subjects us to risk if new scientific information or regulatory judgment prejudices

331、the drugs as a class,which may lead to compelled or voluntary prescription limitations or withdrawal of some or all of such drugs from the market.Our business is subject to international economic,political and other risks that could negatively affect our results of operations and financial condition

332、.We have significant operations in countries that may require complex arrangements to deliver services throughout the world for our clients.Additionally,we have established operations in locations remote from our most developed business centers.As a result,we are subject to heightened risks inherent

333、 in conducting business internationally,including the following:required compliance with a variety of local laws and regulations which may be materially different than those to which we are subject in the United States or which may change unexpectedly;for example,conducting a single clinical trial across multiple countries is complex,and issues in one country,such as a failure to comply with local