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 31,2017 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 and posted on its corporate Web site,if any,every Interactive Data Fi
7、le required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months(or for such shorter period that the registrant was required to submit and post such files).Yes No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
8、S-K is not contained herein,and will not 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 fil
9、er,an accelerated filer,a non-accelerated 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 fil
10、erNon-accelerated filer(Do not check if a smaller reporting company)Smaller reporting 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
11、standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark 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 up
12、on the closing sale price as reported on the New York Stock Exchange on June 30,2017,the last business day of the registrants most recently completed second quarter,was approximately$12,189,011,444.Indicate the number of shares outstanding of each of the issuers classes of Common Stock,as of the lat
13、est practicable date.Class Number of Shares Outstanding Common Stock$0.01 par value208,251,468 shares outstanding as of February 12,2018Portions of the registrants Proxy Statement for the 2018 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Fo
14、rm 10-K to the extent stated herein.Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrants fiscal year ended December 31,2017.2IQVIA HOLDINGS INC.FORM 10-K TABLE OF CONTENTS Item PagePART I 1.Business51A.Risk Factors151B.Unresolved Staff Com
15、ments382.Properties383.Legal Proceedings394.Mine Safety Disclosures40PART II 5.Market for Registrants Common Equity,Related Stockholder Matters and Issuer Purchases of Equity Securities416.Selected Financial Data447.Managements Discussion and Analysis of Financial Condition and Results of Operations
16、467A.Quantitative and Qualitative Disclosures About Market Risk688.Financial Statements and Supplementary Data709.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure1279A.Controls and Procedures1279B.Other Information127PART III 10.Directors,Executive Officers and Co
17、rporate Governance12811.Executive Compensation12912.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters12913.Certain Relationships and Related Transactions and Director Independence13014.Principal Accountant Fees and Services130PART IV 15.Exhibits and Finan
18、cial Statement Schedules131Exhibit Index 13216.Form 10-K Summary136Signatures 1373FORWARD-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 mea
19、ning of the federal securities laws,including Section 27A of the Securities Act of 1933,as 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
20、and our anticipated results of operations,all of which are subject to known and unknown risks,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 s
21、tatements.Therefore,any statements contained herein that are not statements of historical 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
22、,”“will”and the negative thereof and similar words and expressions are intended to identify 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 ri
23、sks or uncertainties materialize,or if underlying assumptions prove incorrect,our actual 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 info
24、rmation included or incorporated by reference in this Form 10-K,including investors and prospective 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 for
25、ward-looking information to reflect actual results or changes in the factors affecting such forward-looking information.GENERAL On October 3,2016,Quintiles Transnational Holdings Inc.(“Quintiles”)completed its previously announced merger of equals transaction(the“Merger”)with IMS Health Holdings,Inc
26、.(“IMS Health”).Pursuant to the terms of the merger agreement dated as of May 3,2016 between Quintiles and IMS Health(the“Merger Agreement”),IMS Health was merged with and into Quintiles,and the separate corporate existence of IMS Health ceased,with Quintiles continuing as the surviving corporation.
27、Immediately prior to the completion of the Merger,Quintiles reincorporated as a Delaware corporation.Quintiles changed its name to Quintiles IMS Holdings,Inc.At the effective time of the Merger,each issued and outstanding share of IMS Health common stock was automatically converted into 0.3840 of a
28、share of the Companys common stock.On November 6,2017,IQVIA Holdings Inc.(the“Company”)filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation(the“Certificate of Amendment”)to effect a change of the Companys name from“Quintiles IMS Holdings,Inc.”to“IQVIA Holdings In
29、c.,”effective as of November 6,2017(the“Name Change”).On November 15,2017,shares of the Company commenced trading under an updated New York Stock Exchange ticker symbol,“IQV,”and a new CUSIP number,46266C 105.When we use the terms“IQVIA,”the“Company,”“we,”“us”or“our”in this Annual Report on Form 10-
30、K,we mean IQVIA Holdings Inc.and its subsidiaries on a consolidated basis,unless we state or the context implies otherwise.INDUSTRY 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 rely on and refer to market
31、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 industry analyses and cannot gua
32、rantee 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 are from IQVIA analyses and
33、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 healthcare industry and we maint
34、ain 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 of this information is avail
35、able 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 been verified by any independ
36、ent 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 estimates and assumptions.4
37、TRADEMARKS AND SERVICE MARKS All trademarks,trade names,product names,graphics and logos of QuintilesIMS,Quintiles,IMS Health or 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 othe
38、r party trademarks,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
39、 endorsement 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
40、 the rights of the applicable licensors to these trademarks,service marks and trade names.We do not intend our use or display of other companies trademarks or service marks to imply an endorsement or sponsorship of us by such other companies.5PART I Item 1.Business Our Company We are a leading globa
41、l provider of information,innovative technology solutions and contract research services focused on helping healthcare clients find better solutions for patients.Formed through the Merger of IMS Health and Quintiles,we apply human data science leveraging the analytic rigor and clarity of data scienc
42、e 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 healthcare outcomes.Powered by the IQVIA CORE,we deliver unique and actionable insights at the inte
43、rsection of large scale analytics,transformative technology and extensive domain expertise,as well as execution capabilities to help biotech,medical device,and pharmaceutical companies,medical researchers,government agencies,payers and other healthcare stakeholders tap into a deeper understanding of
44、 diseases,human behaviors and scientific advances,in an effort to advance their path toward cures.With more than 55,000 employees,we conduct operations in more than 100 countries.We have one of the largest and most comprehensive collections of healthcare information in the world,which includes more
45、than 530 million comprehensive,longitudinal,non-identified patient records spanning sales,prescription and promotional data,medical claims,electronic medical records and social media.Our scaled and growing data set contains approximately 30 petabytes of proprietary data sourced from more than 120,00
46、0 data suppliers and covering over 900,000 data feeds globally.Based on this data,we deliver information and insights on over 85%of the worlds pharmaceuticals,as measured by 2016 sales.We standardize,organize,structure and integrate this data by applying our sophisticated analytics and leveraging ou
47、r 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 breadth of the intelligent,actionable information we provide is not comprehensively available from any other
48、 source and our scope of information would be difficult and costly for another party to replicate.We leverage our proprietary information assets to develop clinical and commercial capabilities with a talented healthcare-focused workforce that enables us to grow our relationships with healthcare stak
49、eholders throughout the life sciences value chain.This set of capabilities includes:A leading healthcare-specific global IT infrastructure,representing what we believe is one of the largest and most sophisticated information technology infrastructures in healthcare.We receive over 70 billion healthc
50、are records annually,our infrastructure then connects complex healthcare data while applying a wide range of privacy,security,operational,legal and contractual protections for data in response to local law,supplier requirements and industry leading practices;Analytics-driven clinical development,whi
51、ch improves clinical trial design,site identification and patient recruitment by empowering therapeutic,scientific,and domain experts with expansive levels of information,including product level tracking in 90 markets,and information about treatments and outcomes on more than 530 million non-identif
52、ied patients;Robust real-world insights ecosystem,with sophisticated retrospective database analytics,prospective real-world data collection technology platforms and scientific expertise,which enables us to address critical healthcare issues of cost,value and patient outcomes;A growing set of propri
53、etary clinical and commercial applications,which helps our clients increase their clinical operations performance and supports their sales operations,sales management,multi-channel marketing and performance management;and A staff of more than 55,000 employees across the globe,including approximately
54、 19,000 Commercial Services employees,approximately 29,000 Research&Development Solutions employees and approximately 7,000 Integrated Engagement Services employees.6Our mission-critical relationships with our life science clients consist of four important decision-making processes related to their
55、product portfolios:Research and Development,Pre-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 opp
56、ortunity assessmentDrug pricing optimizationMarket accessCommercial operationsProject management and clinical monitoringLaunch readinessHealth technology assessmentSales force effectivenessClinical trial support servicesCommercial planningCommercial readinessSales force alignmentPatient recruitmentB
57、rand positioningForecastingMulti-channel marketingClinical trial laboratory servicesMessage testingResource allocationClient relationship managementStrategic clinical trial planning and designInfluence networksContract sales forceLifecycle management Territory designObservational studies Stakeholder
58、 engagement We believe 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 centers have the target patients?Are there enough pati
59、ents for my clinical trial?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 shar
60、e of patients is appropriately 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 thera
61、pies performing better against 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 eviden
62、ce and connected health and technology enabled commercial operations markets for the 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 develop
63、ment totaled approximately$100 billion in 2017.Of that amount,we estimate that our addressable opportunity(clinical development spending excluding preclinical spending)was approximately$59 billion.The portion of this addressable opportunity that was outsourced in 2017,based on our estimates,was appr
64、oximately$26 billion;Real-World Evidence and connected health:Total addressable market of approximately$80 billion based on 2017 sales that consists of two relatively equal parts.First,the market for Real-World Evidence of approximately$40 billion includes traditionally defined analytic platforms an
65、d implementation,medical and scientific 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 commerc
66、ial operations:Total addressable market of approximately$50 billion based on 2017 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 recruitin
67、g,training,deploying and managing global 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 r
68、eview third-party sources,which include 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.W
69、e believe there are six key trends affecting our end markets that will create increasing demand for research and development services and commercial solutions:Growth and innovation in the life sciences industry.The life sciences industry is a large and critical part of the global healthcare system,a
70、nd,according to the latest information available from the IQVIA Market Prognosis service,is estimated to have generated approximately$1.1 trillion in revenue in 2017.According to our research,revenue growth in the life sciences industry globally is expected to range from 3%to 6%between 2018 and 2022
71、.According to the IQVIA Institute,it is estimated that spending on pharmaceuticals in emerging markets will expand at a 6%to 9%compound annual growth rate(“CAGR”)through 2022.The growth of emerging markets is making these geographies strategically important to life sciences organizations and,consist
72、ent with their approach in the 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 a
73、nd performance benchmarking.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
74、 companies efforts to replenish 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 225 new molecular
75、 entities(“NMEs”)are expected to be approved between 2018 and 2022,compared to 208 between 2012 and 2016,and 149 between 2007 and 2011.We believe that further research and development spending,combined with the continued need for cost efficiency across the healthcare landscape,will continue to creat
76、e opportunities for biopharmaceutical 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.Increased Complexity in Research and Development.Biopharmac
77、eutical companies face environments 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 h
78、ave led to more complex development 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 genomic
79、s and our global laboratory network,position us well to help biopharmaceutical companies manage the complexities inherent in an environment where this type of expertise is important.8Regulators require clinical trials involving local populations as part of the process for approving new pharmaceutica
80、l products,especially in certain Asian and emerging markets.Understanding the epidemiological 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
81、multinational and local/regional biopharmaceutical companies.We believe that our global clinical 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.Fin
82、ancial pressures driving the need for increased efficiency.Despite expected accelerating growth 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 complianc
83、e.Product portfolios for life sciences companies have shifted toward specialty products with lower 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 researc
84、h and development through commercial operations will cause them to look to partners as they enter 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 ad
85、opting new technology options such as hosted and cloud-based applications.This provides opportunities 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 admin
86、istrative costs.Evolving need to integrate and structure expanding sources of data.Over the past 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,silo
87、ed in disparate software systems,or entered inconsistently.In addition,new sources of data from 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 va
88、luable insights from existing and expanding sources of information,clients need access to statistically 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 a
89、ggregation and integration of large clinical data sets across all care settings,types of therapies 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 respo
90、nd to particular therapies.Finally,manufacturers also require the ability to analyze social media 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 healthca
91、re data can only be realized through structuring,organizing and integrating new and existing forms 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 r
92、equire assessment of quality and value of therapies and providers.As a result,physicians no longer 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
93、alignment across constituents on the value of their treatments in order to successfully develop 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 e
94、xisting therapies,and will likely receive heightened scrutiny by regulators and payers to determine 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 influen
95、cers that demonstrate therapeutic value.As a result,leading life sciences companies are utilizing more sophisticated outcome research and data analytics services.We believe we are well positioned to take advantage of these global trends in healthcare.Beyond our proprietary information assets,we have
96、 developed key capabilities to assess opportunities to develop and commercialize therapies,support 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.9Our Growth Strategy We
97、 believe we are well positioned for continued growth across the markets we serve.Our strategy for achieving growth includes:Continue to innovate by leveraging our information,advanced analytics,technology and domain expertise.As a leader in the development and commercialization of new pharmaceutical
98、 therapies,we can empower our therapeutic,scientific and domain experts with expansive levels of information including product level tracking in 90 markets and information about treatments and outcomes on more than 530 million non-identified patients.Further,we have the ability to optimize the clini
99、cal trial process and enable 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.Build upon our extensive client relationships.We have
100、 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 research and development and commercial operations which we estimate to be more than$230 billion in 2017.Through the combined offerings of research and devel
101、opment and commercial services we built a platform that allows us to be a more complete partner to our clients.Expand portfolio through strategic acquisitions.We have and expect to continue to acquire assets and businesses that strengthen our value proposition to clients.We have developed an interna
102、l capability to source,evaluate and integrate acquisitions that have created value for stockholders.As the global healthcare landscape evolves,we expect that there will be a growing number of acquisition opportunities across the life sciences,payer and provider sectors.We expect to continue to inves
103、t in or explore opportunities for strategic acquisitions to grow our platform and enhance our ability to provide more services to our clients.Expand the penetration of our offerings to the broader healthcare marketplace.We believe that substantial opportunities exist to expand penetration of our mar
104、ket and further integrate our offerings in a broader cross-section of the healthcare marketplace,particularly connected healthcare.Our Offerings We offer hundreds of distinct services,applications and solutions to help our clients make critical decisions and perform better.We have three operating se
105、gments:Commercial Solutions,Research&Development Solutions and Integrated Engagement Services.Their offerings complement each other and can provide enhanced value to our clients when delivered together,with each driving demand for the other.For financial information regarding our segments,see Part I
106、I,Item 7“Managements Discussion and Analysis of Financial Condition and Results of OperationsConsolidated Results of Operations-Segment Results of Operations and Note 22 to our audited consolidated financial statements included elsewhere in this Annual Report on Form 10-K.Please refer to Note 21 to
107、our audited consolidated financial statements included elsewhere in this Annual Report on Form 10-K for further details regarding our foreign and domestic operations in 2017,2016 and 2015.For a discussion of risks attendant to our foreign operations,see“Risk Factors Our business is subject to intern
108、ational economic,political and other risks that could negatively affect our results of operations and financial condition.”Our Commercial Solutions offerings include:Technology solutions.We provide an extensive range of cloud-based applications and associated implementation services.Software as a Se
109、rvice(“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,customer relationship management(“CRM”),performance management,incentive compensat
110、ion,territory alignment,roster management,call planning,compliance reporting and master data management.These solutions are used by healthcare companies to manage,optimize and execute their clinical and commercial strategies in an orchestrated manner while addressing their regulatory obligations.Usi
111、ng 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 provides a leading source of insight into international mar
112、ket dynamics and are used by most large pharmaceutical companies.10Real-World Insights.We enable clients to use non-identified patient-level data to understand treatments,outcomes,and costs to inform and advance healthcare decision making.With patient privacy and security safeguards,we offer data as
113、sets that integrate medical claims,prescriptions,electronic medical records,biomarkers and government statistics as needed for research requirements.Our proprietary technologies and advanced analytic skills enable us to help payer,government,and biopharmaceutical clients manage and use this informat
114、ion to understand the effectiveness and economic efficiency of drugs in real-world use.Workflow analytics 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 commerci
115、al operations of life sciences companies successfully transform their commercial models,engage more 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 lev
116、erage local market knowledge,deep scientific and therapeutic area expertise and our global information 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 offe
117、rings comprise unique services in 90 countries that provide consistent country level performance 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
118、integral part of critical processes in life science companies around the world and are also used 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 more than 70 countries
119、that provide a consistent measurement of sales or prescribing activity at the regional,zip code and 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
120、 on these services to set goals,determine resourcing,measure performance and calculate compensation.Reference information offerings.Our widely used reference database that tracks more than 15 million healthcare professionals in approximately 100 countries,providing a comprehensive view of health car
121、e practitioners that is critical for the commercial success of our clients marketing and sales initiatives.Our Research&Development Solutions(“RDS”)offerings include:Project Management and Clinical Monitoring.Drawing upon our years of experience,our site databases,our site relationships and our high
122、ly trained staff,Clinical Solutions&Services enables the efficient conduct and coordination of multi-site clinical trials(generally Phase II-IV).Clinical Solutions&Services service offerings include protocol design,feasibility and operational planning,site start up and patient recruitment.Clinical T
123、rial 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 ev
124、idence 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 bioana
125、lytical laboratory services supporting clinical trials offerings within the joint venture,which is referred to as Q2 Solutions.Strategic Planning and Design.Through our strategic planning and design services,we offer consultation services to improve decisions and performance including portfolio,prog
126、ram and protocol planning and design,biomarker consultation,benefit-risk management,regulatory affairs,biostatistics,modeling and simulation,and personalized medicine.11Our principal Integrated Engagement Services(“IES”)offerings include:Health Care Provider Engagement Services.We partner with bioph
127、armaceutical 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,which are focused on improving brand value at all stages of the product lifecycle from initi
128、al 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 interventional and non-interventional support,while also providing assistance in navigating complex re
129、imbursement coverage issues.Our patient engagement services combine insight from clinical trials and social listening,behavioral design,personal and innovative eHealth multichannel interactions across multiple sites(e.g.,the physicians office,hospital,pharmacy,home),that act as an extension of the H
130、ealth 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 to help biopharmaceutical companies plan and transition from the clinical trial setting to
131、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 clinical trial data into a compelling scientific platform and publication strategy,and,provide fi
132、eld 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 pharmaceutical companies,biotechnology companies,device and diagnostic companies,and consumer heal
133、th 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 reports and services in many countries.Other clients include payers,government and regulatory a
134、gencies,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 company revenues in 2017,2016 or 2015.Our Competition Our Commercial Solutions business com
135、petes 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 which we operate with other information,analytics,technology,services and consulting companies,as well a
136、s 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 addition to country-by-country competition,we have a number of regional and global competitors in the market
137、place as well.Our offerings compete with various firms,including Accenture,Cognizant Technology Solutions,Covance,Deloitte,Evidera,GfK,LexisNexis Risk Solutions,IBM,Infosys,Kantar Health,McKinsey,Nielsen,OptumInsight,Parexel,Press Ganey,RTI Health Solutions,Symphony Health Solutions,Synovate Healthc
138、are,The Advisory Board,Trizetto,Veeva,Verisk,and ZS Associates.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 off
139、erings are highly competitive,and we compete against traditional 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 pro
140、viders,several medium-sized firms and only a few full-service 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
141、.,PRA International,and Syneos Health,among others.Our Integrated Engagement Services business competes against the in-house sales and marketing departments of biopharmaceutical companies,other contract pharmaceutical sales and service organizations and consulting firms.Integrated Engagement Service
142、s primary competitor in the United States is Syneos Health.Outside of the United States,Integrated Engagement Services typically competes against single country or more regionally focused service providers,such as United Drug plc,Syneos Health,Publicis,EPS Corporation and CMIC HOLDINGS Co.,Ltd.12Gov
143、ernment Regulation Many aspects 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
144、.There are,however,occasionally 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
145、 and guidelines are the industry 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 Welfa
146、re and most other global regulatory 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
147、.Regulation of Drugs,Biologics 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
148、 and regulations,govern,among 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
149、to comply with applicable United 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(“P
150、MA”)or clearance for a new medical device,warning or untitled letters,product recalls,product seizures,total or partial suspension of production or distribution,injunctions,fines,civil penalties,and criminal prosecution.Regulation of Patient Information Our information management services relate to
151、the processing 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 incl
152、usion in our 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 pers
153、onal financial 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 h
154、ealth or other 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
155、category of personal 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 Distrib
156、ution of Pharmaceutical 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 produ
157、cts,the qualifications of sales representatives and the use of healthcare professionals in sales functions.13In 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
158、of our services 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 keepin
159、g,packaging,labeling,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 hea
160、lthcare items and 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 Integrated
161、Engagement Services.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 pena
162、lties,including 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 laborato
163、ry employees.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 Enviro
164、nmental Protection 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 St
165、ates by the DEA 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
166、 surface and 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 materi
167、als becomes subject 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,hazardous waste and radioactive materials,as well as the
168、 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 exposed
169、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 penalties
170、 and other enforcement actions.Further,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 failure to
171、 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 intellect
172、ual 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 our trad
173、emark 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,QuintilesIMS,Quintiles,IMS Health and IMS,in the United States and other jurisdictions and aggressively seek to prot
174、ect them.Trademarks and service marks 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
175、of importance to our business,although 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 31,2017,we have more than 55,000 employees worldwide.Almost all of these employees are full-time.No
176、ne of our employees are covered by a 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.14Available Information Our website address is ,and our investor relations
177、website is located at http:/.Information 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
178、 well as Section 16 reports filed by our 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”).Our SEC filings are also available for reading and copying at the SEC
179、s Public Reference Room at 100 F Street,NE,Washington,D.C.20549.Information on the operation of the Public Reference Room may be obtained by calling the SEC at 1-800-SEC-0330.In addition,the SEC maintains an Internet site(http:/www.sec.gov)containing reports,proxy and information statements,and othe
180、r 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 Compensation Commi
181、ttee 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 Investor Relations
182、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 Business Conduct or the Code of Ethics for Chief Executive Officer and Senior Financial Officers or any waiver of either such policy applicable to an
183、y of our senior financial officers,executive officers or directors.15 Item 1A.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
184、with the other information included in this Annual Report on Form 10-K,including 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 ou
185、r business,financial condition,results of operations and future prospects.Risks 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
186、30 to 90 days notice.Our clients may delay,terminate or reduce the scope of our 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
187、by regulatory authorities;production problems resulting in shortages of the drug 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 in
188、vestigator recruitment;shift of business to a competitor or internal resources;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 o
189、f termination,our contracts often provide for fees for winding down the project,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 committ
190、ed services if our clients cancel,delay or reduce their commitments under our 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
191、of multiple contracts could adversely affect our revenues and profitability.We 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.We depend on third parties for data and
192、support services.Our suppliers or providers might restrict our use of or refuse 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
193、of our Commercial Solutions information services is derived from 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.16Although we typically enter into long-term contractual arrangements wi
194、th many of these suppliers of data,at the time of entry into a new 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
195、 supply contract,suppliers may fail to adhere to our data quality control 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 o
196、ur services were to impose additional contractual restrictions on our 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 adver
197、sely impacted,which may harm our operating results and financial condition.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
198、trials,suppliers of kits for use in our clinical trial laboratories 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 mate
199、rial adverse effect on our business.If we fail to perform our services 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
200、perform a wide range of services to assist them in bringing new drugs to market.Our services include monitoring clinical trials,data and laboratory analysis,electronic data capture,patient recruitment and other related services.Such services are complex and subject to contractual requirements,regula
201、tory standards and ethical considerations.For example,we must adhere to regulatory requirements such as the FDA and current GCP,Good Laboratory Practice and Good Manufacturing Practice requirements.If we fail to perform our services in accordance with these requirements,regulatory agencies may take
202、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 withdrawal of ap
203、provals,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 approved on th
204、e 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:Improper performanc
205、e 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 reported impr
206、operly.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 and marketing
207、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 at no further
208、 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 such risks,impro
209、per 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.Investigation of clients.From time to time,one or more
210、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 to the clinica
211、l 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 we are responsib
212、le 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 drugs could have
213、 an adverse effect on our business and reputation.17Insufficient 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 or unable to f
214、und 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 breaches and unaut
215、horized 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 cyberattacks
216、 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 integrity of our syst
217、ems,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,introduce maliciou
218、s 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,and because cyb
219、erattacks 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 related to,for e
220、xample,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 reputation with c
221、lients 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 inappropriate d
222、isclosure 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 of suppliers a
223、nd 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 government agencies as
224、 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 operating re
225、sults 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 communications envir
226、onments.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 us,which could
227、 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 transformation initi
228、atives 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 our business
229、 processes and functions to achieve economies of scale.For example,we are moving local standardizing and cleaning from countries around the world to Asia,and retiring local standardizing and cleaning systems.These various initiatives may not yield their intended gains,which may impact our competitiv
230、eness and our ability to meet our growth objectives and,as a result,materially and adversely affect our business,operating results and financial condition.18If we are unsuccessful at investing in growth opportunities,our business could be materially and adversely affected.We continue to invest signi
231、ficantly in growth opportunities,including the development and acquisition of new data,technologies and services to meet our clients needs.For example,we are expanding our services and technology offerings,such as the development of a cloud-based platform with a growing number of applications to sup
232、port commercial operations for life sciences companies(e.g.,multi-channel marketing,marketing campaign management,customer relationship management,incentive compensation management,targeting and segmentation,performance management and other applications).We also continue to invest significantly in g
233、rowth opportunities in emerging markets,such as the development,launch and enhancement of services in China,India,Russia,Turkey and other countries.We believe healthcare spending in these emerging markets will continue to grow over the next five years,and we consider our presence in these markets to
234、 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 or any return on our investments.Further,if we are unable to develop new technologies and services,clients do not purchase our new technolo
235、gies 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 services,then we may not be able to grow our business or growth may occur slower than anticipated.Additionally,although we expect continued grow
236、th 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 plan to fund growth opportunities with cash from operations or from future financings.There can be no assurance that those sources will be a
237、vailable in sufficient amounts to fund future growth opportunities when needed.Any of the foregoing could have a material and adverse effect on our operating results and financial condition.Data protection,privacy and similar laws in the United States and around the world restrict access,use and dis
238、closure of personal information,and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.The confidentiality,collection,use and disclosure of personal data,including individually identifiable health information and clinical trial patient-specific
239、information,are subject to governmental regulation generally in the country that the personal data were collected or used.For example,United States federal regulations under the Health Insurance Portability and Accountability Act of 1996(“HIPAA”)create specific requirements for the protection of the
240、 privacy and security of individual health information.These provisions apply to both“covered entities”(primarily health care providers and health insurers)and their“business associates”or service providers.As there are some instances where we are a HIPAA“business associate”of a“covered entity,”we c
241、an be directly liable for mishandling protected health information.Under HIPAAs enforcement scheme,we can be subject to significant penalties in connection with HIPAA violations,along with the potential for significant other expenditures related to these activities.These rules require individuals wr
242、itten authorization in many situations,in addition to any required informed consent,before protected health information may be used for research.We are both directly and indirectly affected by the privacy provisions surrounding individual authorizations because many investigators with whom we are in
243、volved in clinical trials are directly subject to them as a HIPAA“covered entity”and because we obtain identifiable health information from third parties that are subject to such regulations.The laws and regulations related to the protection of personal health information in connection with research
244、 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 provide some of our services in their current form or maintain our profitability.In general,patient health information is among the most sensi
245、tive(and highly regulated)of personal information and laws and regulations around the United States and the world are designed to ensure that information about an individuals healthcare is properly protected from inappropriate access,use and disclosure.Laws restricting access,use and disclosure of p
246、atient health information also include the European Unions(“EU”)General Data Protection Regulation,Canadas Personal Information Protection and Electronic Documents Act and other data protection,privacy,data security and similar national,state/provincial and local laws.In the EU personal data include
247、s any information that relates to an identified or identifiable natural person with health information carrying additional obligations,including obtaining the explicit consent from the individual for collection,use or disclosure of the information.In addition,we are subject to EU rules with respect
248、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 states,and other countries where we have operations,such as Japan,South Korea,Malaysia,the Philippines,Russia and Singapore,continue to issue
249、 new privacy and data protection rules and regulations that relate to personal data and health information.19We have established frameworks,models,processes and technologies to manage privacy and security for many data types,from a variety of sources,and under myriad privacy and data protection laws
250、 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 protection laws.These laws are complex and there is no assurance that the safeguards and controls employed by us or our data suppliers will be su
251、fficient 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 comply with such laws,certain certification/registration and annual re-certification/registration provisions associated with these data protect
252、ion and privacy regulations,and similar rules in various jurisdictions,or to resolve any serious privacy complaints,may result in,among other things,regulatory sanctions,criminal prosecution,civil liability,negative publicity,damage to our reputation,or data being blocked from use or liability under
253、 contractual provisions.For example,in July 2015,indictments were issued by the Seoul Central District Prosecutors Office in South Korea against IMS Korea and two of its employees,among others,alleging improper handling of sensitive health information in violation of applicable privacy laws.See Item
254、 3“Legal Proceedings”for additional information.Laws and expectations relating to privacy continue to evolve,and we continue to adapt to changing needs.For example,the definition of“personally identifiable information”and“personal data”continues to evolve and broaden and many new laws and regulation
255、s 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 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 pro
256、grams may adversely impact our ability to provide services to our clients or develop new products or services.Federal,state and foreign governments are contemplating or have proposed or adopted additional legislation governing the collection,possession,use or dissemination of personal data,such as p
257、ersonal health information,and personal financial 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 new security measures and processes or bring within the legislation o
258、ther personal data not currently regulated,each of which may require substantial expenditures or limit our ability to offer some of our services.Additionally,changes in these laws(including newly released interpretations of these laws by courts and regulatory bodies)may limit our data access,use and
259、 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 adverse impact on our ability to provide services to our clients or maintain our profitability.There is ongoing concern from privacy advocates,
260、regulators and others regarding data protection and privacy issues,and the number of jurisdictions with data protection and privacy laws has been increasing.Also,there are ongoing public policy discussions regarding whether the standards for de-identified,anonymous or pseudonymized health informatio
261、n are sufficient,and the risk of re-identification sufficiently small,to adequately protect patient privacy.These discussions may lead to further restrictions on the use of such information.There can be no assurance that these initiatives or future initiatives will not adversely affect our ability t
262、o 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 although they vary by jurisdiction,these laws can extend to employee information,business contact information,provider information and other inf
263、ormation relating to identifiable individuals.Failure to comply with these laws may result in,among other things,civil and criminal liability,negative publicity,damage to our reputation and liability under contractual provisions.In addition,compliance with such laws may require increased costs to us
264、 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 service to our clients,require us to modify our offerings or increase our costs,which could materially and adversely affect our operating results a
265、nd financial condition.Our success depends on our ability to protect our intellectual property rights.Our success depends,in part,upon our ability to develop,use and protect our proprietary methodologies,analytics,systems,technologies and other intellectual property.Existing laws of the various coun
266、tries in which we provide services or solutions offer only limited protection of our intellectual property rights,and the protection in some countries may be very limited.We rely upon a combination of trade secrets,confidentiality policies,nondisclosure,invention assignment and other contractual arr
267、angements,and patent,copyright and trademark laws,to protect our intellectual property rights.These laws are subject to change at any time and certain agreements may not be fully enforceable,which could further restrict our ability to protect our innovations.Our intellectual property rights may not
268、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 prevent or deter infringement or other misappropriation of our intellectual property by competitors,former employees or other third parties,a
269、nd 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 obtain,protect and enforce our intellectual property rights is subject to general litigation or third-party opposition risks,as well as the uncerta
270、inty as to the scope of protection,registrability,patentability,validity and enforceability of our intellectual property rights in each applicable country.Governments may adopt regulations,and government agencies or courts may render decisions,requiring compulsory licensing of intellectual property
271、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.Litigation may be necessary in the future to enforce our intellectual property rights and to protect our confidential and proprietary informa
272、tion.Litigation brought to protect and enforce our intellectual property rights could be costly,time consuming and distracting to management and could result in the impairment or loss of portions of our intellectual property rights.Furthermore,our efforts to enforce our intellectual property rights
273、may be met with defenses,counterclaims and countersuits attacking the validity and enforceability of our intellectual property rights.Our inability to protect our proprietary technology against unauthorized copying or use,as well as any costly litigation or diversion of our managements attention and
274、 resources,could delay further sales or the implementation of our solutions,impair the functionality of our solutions,delay introductions of new solutions,result in our substituting inferior or more costly technologies into our solutions,or injure our reputation and harm our operating results and fi
275、nancial condition.Depending on the circumstances,we might need to grant a specific client greater rights in intellectual property developed in connection with a contract than we otherwise generally do.In certain situations,we might forego all rights to the use of intellectual property we create,whic
276、h would limit our ability to reuse that intellectual property for other clients.Any limitation on our ability to provide a service or solution could cause us to lose revenue-generating opportunities and require us to incur additional expenses to develop or license new or modified solutions for futur
277、e projects.The theft or unauthorized use or publication of our trade secrets and other confidential business information could reduce the differentiation of our services and harm our business;the value of our investment in development or business acquisitions could be reduced;and third parties might
278、 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 extent of any unauthorized use of our proprietary rights.Third parties that license our proprietary rights also may take actions that diminish the va
279、lue of our proprietary rights or reputation.The protection of our intellectual property may require the expenditure of significant financial and managerial resources.Moreover,the steps we take to protect our intellectual property may not adequately protect our rights or prevent third parties from in
280、fringing or misappropriating our proprietary rights.These incidents and claims could harm our business,reduce revenue,increase expenses and harm our reputation.We may be subject to claims by others that we are infringing on their intellectual property rights.Third parties may assert claims that we o
281、r our clients infringe their intellectual property rights and these claims,with or without merit,could be expensive to litigate,cause us to incur substantial costs and divert management resources and attention in defending the claim.In some jurisdictions,plaintiffs can also seek injunctive relief th
282、at may limit the operation of our business or prevent the marketing and selling of our services that infringe on the plaintiffs intellectual property rights.To resolve these claims,we may enter into licensing agreements with restrictive terms or significant fees,stop selling,be required to implement
283、 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 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
284、 and financial condition.In addition,certain contracts with our suppliers or clients contain provisions whereby we indemnify,subject to certain limitations,the counterparty for damages suffered as a result of claims related to intellectual property infringement and the use of our data.Claims made un
285、der these provisions could be expensive to litigate and could result in significant payments.We rely on licenses from third parties to certain technology and intellectual property rights for some of our services and the licenses we currently have could terminate or expire.Some of our business servic
286、es rely on technology or intellectual property rights owned and controlled by others.Our licenses to this technology or these intellectual property rights 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
287、these licenses on less advantageous terms,could harm our operating results and financial condition.21Our financial results may be adversely affected if we underprice our contracts,overrun our cost estimates or fail to receive approval for or experience delays in documenting change orders.Most of our
288、 Research&Development Solutions contracts are either fee for service contracts or fixed-fee contracts.Our past financial results have been,and our future financial results may be,adversely impacted if we initially underprice our contracts or otherwise overrun our cost estimates and are unable to suc
289、cessfully negotiate a change order.Change orders typically occur when the scope of work we perform needs to be modified from that originally contemplated by 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 si
290、gnificant 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 additional work.Such underpricing,significant cost overruns or delay in documentation of change orders could have a material adverse effect on
291、 our business,results of operations,financial condition or cash flows.The relationship of backlog to revenues varies over time.Backlog represents future revenues for our Research&Development Solutions business from work not yet completed or performed under signed binding commitments and signed contr
292、acts.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 regulatory authorities for reasons beyond our control.To the extent projects are delayed,the timing of our revenue could be affected.In the even
293、t 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 client-authorized services related to terminating the canceled project.Typically,however,we have no contractual right to the full amount of the r
294、evenue reflected in our backlog in the event of a contract cancellation.The duration of the projects included in our backlog,and the related revenue recognition,range from a few weeks to many years.Our backlog may not be indicative of our future revenues from our Research&Development Solutions busin
295、ess,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 and duration of the projects;the percentage of full services versus functional services;the cancellation or delay of projects;and change in the
296、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(depending on the level of cancellations),an increase in backlog at a particular point in time does not necessarily correspond directly to an increa
297、se 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 to delivery against projected schedules,the need for scope changes(change orders),contract cancellations and the nature,duration,size,complexity
298、 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 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 v
299、ariety 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 the contract,as well as an increased timeframe for obtaining the necessary regulatory approvals.Additionally,the increased complexity of clinical
300、 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 of time.Further,delayed projects will remain in backlog,unless otherwise canceled by the client,and will not generate revenue at the rate origin
301、ally expected.Thus,the relationship of backlog to realized revenues may vary over time.22Our business depends on the continued effectiveness and availability of our information systems,including the information systems we use to provide our services to our clients,and failures of these systems may m
302、aterially 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 our use of web-enabled and other integrated information systems in delivering our services.We also provide access to similar information syste
303、ms 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 will increasingly be exposed to the risks inherent in the development,integration and ongoing operation of evolving information systems,including:
304、disruption,impairment or failure of data centers,telecommunications facilities or other key infrastructure platforms;security breaches of,cyberattacks on and other failures or malfunctions in our critical application systems or their associated hardware;and excessive costs,excessive delays or other
305、deficiencies in systems development and deployment.The materialization of any of these risks may impede the processing of data,the delivery of databases and services,and the day-to-day management of our business and could result in the corruption,loss or unauthorized disclosure of proprietary,confid
306、ential 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 operations have disaster recovery plans in place,we currently do not have excess or standby computer processing or network capacity everywhere i
307、n 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 fire,floods,hurricanes,power loss,telecommunications failures,computer viruses,break-ins and similar events at our various computer facilities c
308、ould 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 repeat 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 additio
309、n,any failure by our computer environment to provide sufficient processing or network capacity to transfer data could result in interruptions in our service.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 s
310、erver hosting services.Such a transfer could result in significant delays in our ability to deliver services to our clients,and increase our costs.Additionally,significant delays in system enhancements or inadequate performance of new or upgraded systems once completed could damage our reputation an
311、d harm our business.Finally,long-term disruptions in the infrastructure caused by events such as natural disasters,the outbreak of war,the escalation of hostilities and acts of terrorism,particularly involving cities in which we have offices,could adversely affect our businesses.Although we carry pr
312、operty and business interruption insurance,our coverage might not be adequate to compensate us for all losses that may occur.We have continued to undertake significant programs to optimize business processes with respect to our services.Our inability to effectively manage the implementation and adap
313、t 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 affect our operations.We have entered into agreements with certain vendors to provide systems development and integration services that develop or li
314、cense 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 in developing,implementing and updating the IT platform,our client delivery may be impaired,and we may have to make substantial further investmen
315、ts,internally or with third parties,to achieve our objectives.Additionally,our progress may be limited by parties with existing or claimed patents who seek to enjoin us from using preferred technology or seek license payments from us.Meeting our objectives is dependent on a number of factors which m
316、ay not take place as we anticipate,including obtaining adequate technology-enabled services,creating IT-enabled services that our clients will find desirable and implementing our business model with respect to these services.Also,increased IT-related expenditures may negatively impact our profitabil
317、ity.23We may experience challenges with the acquisition,development,enhancement or deployment of technology necessary for our business.We operate in businesses that require sophisticated computer systems and software for data collection,data processing,cloud-based platforms,analytics,cryptography,st
318、atistical projections and forecasting,mobile computing,social media analytics and other applications and technologies,particularly our Commercial Solutions business.We seek to address our technology risks by increasing our reliance on the use of innovations by cross-industry technology leaders and a
319、dapt these for our biopharmaceutical and healthcare industry clients.Some of these technologies supporting 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 c
320、lients in forms that are easy to use while simultaneously providing clear answers to complex questions.There 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
321、we will be able to do so as quickly or cost-effectively as our competitors.Significant technological change 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
322、will depend on our ability to adapt to changing technologies,manage and process ever-increasing amounts of 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
323、prevent the successful design,development,testing,introduction or marketing of our services.New services,or 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 cou
324、ld have a material adverse effect on our operating results and financial condition.Consolidation in the industries 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
325、 financial condition.Mergers or consolidations among our clients have in the past and could in the future 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,lead
326、ing to loss of revenue.Other services that were previously purchased by one of the merged or consolidated 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 red
327、uce their use of our services.There can be no assurance as to the degree to which we may be able to address 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 con
328、centration.Although we did not have any client that represented 10%or more of our revenues in 2017,2016 and 2015,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
329、condition could be materially adversely affected.Additionally,conducting multiple clinical trials for different 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 cli
330、nical trials are canceled because of new scientific information or regulatory judgments that affect the drugs 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 simi
331、lar chemical actions subjects us to risk if new scientific information or regulatory judgment prejudices 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.24Our business is subject to international econom
332、ic,political and other risks that could negatively affect our results of operations and financial condition.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 locati
333、ons remote from our most developed business centers.As a result,we are subject to heightened risks inherent 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
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