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 31,2019 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 classTrading Symbol(s)Name
4、of each exchange on which registeredCommon Stock,par value$0.01 per shareIQVNew York Stock Exchange Securities 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
5、check mark if the registrant 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
6、twelve months(or for such shorter period that the registrant was required to file such reports),and(2)has been subject to such filing requirements for the past 90 days.Yes No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitt
7、ed pursuant to Rule 405 ofRegulation S-T(232.405 of this chapter)during the preceding 12 months(or for such shorter period that the registrant was required to submit such files).Yes No Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated f
8、iler,a smaller reporting company,or emerging growth company.See the definitions of“large accelerated filer,”“accelerated filer,”“smaller reporting company,”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filer Accelerated filerNon-accelerated filerSmaller reporting co
9、mpanyEmerging growth companyIf an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark w
10、hether the registrant is a shell company(as defined in Rule 12b-2 of the Exchange Act).Yes No The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant,based upon the closing sale price as reported on the New York Stock Exchange on June 28,2019,the
11、 last business day of the registrants most recently completed second quarter,was approximately$28.6 billion.As of February 7,2020,there were approximately 192,339,093 shares of the registrants common stock outstanding.Portions of the registrants Proxy Statement for the 2020 Annual Meeting of Stockho
12、lders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein.Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrants fiscal year ended December 31,2019.2IQVIA HOLDINGS INC.FORM 10-K TAB
13、LE OF CONTENTS Item PagePART I 1.Business51A.Risk Factors131B.Unresolved Staff Comments342.Properties353.Legal Proceedings354.Mine Safety Disclosures35PART II 365.Market for Registrants Common Equity,Related Stockholder Matters and Issuer Purchases of Equity Securities366.Selected Financial Data397.
14、Managements Discussion and Analysis of Financial Condition and Results of Operations417A.Quantitative and Qualitative Disclosures About Market Risk548.Financial Statements and Supplementary Data559.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure1049A.Controls and
15、 Procedures1049B.Other Information104PART III 10510.Directors,Executive Officers and Corporate Governance10511.Executive Compensation10612.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters10713.Certain Relationships and Related Transactions and Director I
16、ndependence10714.Principal Accountant Fees and Services107PART IV 10815.Exhibits and Financial Statement Schedules108Exhibit Index10916.Form 10-K Summary113Signatures1143FORWARD-LOOKING STATEMENTS Except for any historical information contained herein,the matters discussed or incorporated by referen
17、ce in this Annual Report on Form 10-K contains forward-looking statements within the meaning of the federal securities laws,including Section 27A of the Securities Act of 1933,as amended(“Securities Act”),and Section 21E of the Securities Exchange Act of 1934,as amended(the“Exchange Act”).Such forwa
18、rd-looking statements reflect,among other things,our current expectations,our forecasts and our anticipated results of operations,all of which are subject to known and unknown risks,uncertainties and other factors that may cause our actual results,performance or achievements,market trends,or industr
19、y results to differ materially from those expressed or implied by such forward-looking statements.Therefore,any statements contained herein that are not statements of historical fact may be forward-looking statements and should be evaluated as such.Without limiting the foregoing,the words“anticipate
20、s,”“believes,”“estimates,”“expects,”“intends,”“may,”“plans,”“projects,”“should,”“targets,”“will”and the negative thereof and similar words and expressions are intended to identify forward-looking statements.We caution you that any such forward-looking statements are further qualified by important fa
21、ctors that could cause our actual operating results to differ materially from those in the forward-looking statements,including without limitation,that most of our contracts may be terminated on short notice,and we may lose or experience delays with large client contracts or be unable to enter into
22、new contracts;imposition of restrictions on our use of data by data suppliers or their refusal to license data to us;any failure by us to comply with contractual,regulatory or ethical requirements under our contracts,including current or changes to data protection and privacy laws;breaches or misuse
23、 of our or our outsourcing partners security or communications systems;hardware and software failures,delays in the operation of our computer and communications systems or the failure to implement system enhancements;failure to meet our productivity or business transformation objectives;failure to s
24、uccessfully invest in growth opportunities;our ability to protect our intellectual property rights and our susceptibility to claims by others that we are infringing on their intellectual property rights;the expiration or inability to acquire third party licenses for technology or intellectual proper
25、ty;any failure by us to accurately and timely price and formulate cost estimates for contracts,or to document change orders;the rate at which our backlog converts to revenue;our ability to acquire,develop and implement technology necessary for our business;consolidation in the industries in which ou
26、r clients operate;risks related to client or therapeutic concentration;the risks associated with operating on a global basis,including currency or exchange rate fluctuations and legal compliance,including anti-corruption laws;risks related to changes in accounting standards;general economic conditio
27、ns in the markets in which we operate,including financial market conditions and risks related to sales to government entities;the risks associated with business disruptions caused by natural disasters,pandemics such as the COVID-19(coronavirus)or international conflict or other disruptions outside o
28、f our control;the impact of changes in tax laws and regulations;and our ability to successfully integrate,and achieve expected benefits from,our acquired businesses.These forward-looking statements are subject to a number of risks,uncertainties and assumptions,including those described in Part I,Ite
29、m 1A,“Risk Factors.”If one or more of these risks 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 reaso
30、ns.Given these uncertainties,users of the information 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.
31、We assume no obligation to update any such forward-looking information to reflect actual results or changes in the factors affecting such forward-looking information.GENERAL When we use the terms“IQVIA,”the“Company,”“we,”“us”or“our”in this Annual Report on Form 10-K,we mean IQVIA Holdings Inc.and it
32、s subsidiaries on a consolidated basis,unless we state or the context implies otherwise.4INDUSTRY AND MARKET DATA This annual report on Form 10-K includes market data and forecasts with respect to the healthcare industry.In some cases,we rely on and refer to market data and certain industry forecast
33、s 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 guarantee their accuracy or completen
34、ess.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 have been identified accordingly,i
35、ncluding,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 maintain databases,produce market analy
36、ses 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 available on a subscription basis.Other
37、 reports and information are available publicly through our IQVIA Institute for Human Data Science(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 independent sources.Our estimates and assumpti
38、ons involve risks and uncertainties and are subject to change based on various factors,including those discussed in Part I,Item IA,“Risk Factors”.These and other factors could cause results to differ materially from those expressed in the estimates and assumptions.TRADEMARKS AND SERVICE MARKS All tr
39、ademarks,trade names,product names,graphics and logos of IQVIA contained herein are trademarks or registered trademarks of IQVIA Holdings Inc.or its subsidiaries,as applicable,in the United States and/or other countries.All other party trademarks,trade names,product names,graphics and logos containe
40、d 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 endorsement or sponsorship of IQVIA Inc.or its subsidiaries by such oth
41、er party.Solely for convenience,the trademarks,service marks and trade names referred to in this annual report are listed without the,(sm)and(TM)symbols,but we will assert,to the fullest extent under applicable law,our rights or the rights of the applicable licensors to these trademarks,service mark
42、s and trade names.5PART I Item 1.Business Our Company IQVIA is a leading global provider of advanced analytics,technology solutions and contract research services to the life sciences industry.Formed through the Merger of IMS Health and Quintiles,IQVIA applies human data science leveraging the analy
43、tic rigor and clarity of data science to the ever-expanding scope of human science to enable companies to reimagine and develop new approaches to clinical development and commercialization,speed innovation,and accelerate improvements in healthcare outcomes.Powered by the IQVIA CORE,we deliver unique
44、 and actionable insights at the intersection of large scale analytics,transformative technology and extensive domain expertise as well as execution capabilities.With approximately 67,000 employees,we conduct operations in more than 100 countries.We have one of the largest and most comprehensive coll
45、ections of healthcare information in the world,which includes more than 800 million comprehensive,longitudinal,non-identified patient records spanning sales,prescription and promotional data,medical claims,electronic medical records,genomics,and social media.Our scaled and growing information set co
46、ntains over 35 petabytes of proprietary data sourced from more than 150,000 data suppliers and covering over one million data feeds globally.Based on this data,we deliver information and insights on over 85%of the worlds pharmaceuticals,as measured by 2018 sales.We standardize,curate,structure and i
47、ntegrate this information by applying our sophisticated analytics and leveraging our global technology infrastructure.This helps our clients run their organizations more efficiently and make better decisions to improve their clinical,commercial and financial performance.The breadth of the intelligen
48、t,actionable information we provide is not comprehensively available from any other source and our scope of information would be difficult and costly for another party to replicate.We combine our proprietary information assets with advanced analytics,transformative technology and domain expertise to
49、 develop clinical and commercial capabilities that enable us to grow our relationships with healthcare stakeholders throughout the life sciences value chain.This set of capabilities includes:A leading healthcare-specific global IT infrastructure,representing what we believe is one of the largest and
50、 most sophisticated information technology(“IT”)infrastructures in healthcare.We receive over 95 billion healthcare records annually,and our infrastructure then connects complex healthcare data while applying a wide range of privacy,security,operational,legal and contractual protections for data in
51、response to local law,supplier requirements and industry leading practices;Analytics-driven clinical development,which improves clinical trial design,site identification and patient recruitment by empowering therapeutic,scientific,and domain experts with expansive levels of information,including pro
52、duct level tracking in 90 markets,and information about treatments and outcomes on more than 800 million non-identified patients globally;Robust real world solutions ecosystem,with sophisticated retrospective database analytics,prospective real world data collection technology platforms and scientif
53、ic expertise,which enables us to address critical healthcare issues of cost,value and patient outcomes;A growing set of proprietary clinical and commercial applications,which helps our clients increase their clinical operations performance,supports their regulatory and compliance needs and orchestra
54、tes their sales operations,sales management,multi-channel marketing and performance management;and A staff of approximately 67,000 employees across the globe,including over 23,000 Technology&Analytics Solutions employees,approximately 35,000 Research&Development Solutions employees and approximately
55、 7,000 Contract Sales&Medical Solutions employees.Integration of information,analytics,technology,and domain expertise through the IQVIA CORE,which enables us to provide our clients with more effective options to address their needs from Research and Development through commercialization as well as
56、truly innovative breakthroughs such as virtual trials and global real-world evidence networks.6Our Market Opportunity We compete in a market of greater than$230 billion consisting of outsourced research and development,real-world evidence and connected health and technology enabled clinical and comm
57、ercial operations markets for life sciences companies and the broader healthcare industry.The following sets forth our estimates for the size of our principal markets:Outsourced research and development:Biopharmaceutical spending on drug development totaled over$100 billion in 2019.Of that amount,we
58、 estimate that our addressable opportunity(clinical development spending excluding preclinical spending)was approximately$66 billion.The portion of this addressable opportunity that was outsourced in 2019,based on our estimates,was approximately$35 billion;Real-World Evidence and connected health:To
59、tal addressable market of approximately$80 billion based on 2019 sales that consists of two relatively equal parts.First,the market for Real-World Evidence of approximately$40 billion includes traditionally defined analytic platforms and implementation,medical and scientific analytic services,observ
60、ation studies and market access.Second,the market for connected healthcare of approximately$40 billion includes areas such as revenue cycle management,payer analytics and clinical decision support services;and Technology enabled commercial operations:Total addressable market of approximately$50 bill
61、ion based on 2019 sales that includes information,data warehousing,IT outsourcing,software applications and other services in the broader market for IT services.This addressable market also includes commercial services such as recruiting,training,deploying and managing global sales forces,channel ma
62、nagement,patient engagement services,market access consulting,brand communication,advisory services,and health information analytics and technology consulting.In deriving estimates of the size of the various markets described above,we review third-party sources,which include estimates and forecasts
63、of spending in various segments,in combination with internal IQVIA research and analysis informed by our experience serving these segments,as well as projected growth rates for each of these segments.See“Industry and Market Data”above.We believe there are six key trends affecting our end markets tha
64、t will create increasing demand for research and development services,technology&analytics solutions and contract and medical solutions:Growth and innovation in the life sciences industry.The life sciences industry is a large and critical part of the global healthcare system,and,according to the lat
65、est information available from the IQVIA Market Prognosis service,is estimated to have generated approximately$1.25 trillion in revenue in 2019.According to our research,revenue growth in the life sciences industry globally is expected to range from 3%to 6%between 2020 and 2024.According to the IQVI
66、A Institute,it is estimated that spending on pharmaceuticals in emerging markets will expand at a 5%to 8%compound annual growth rate(“CAGR”)through 2024.The growth of emerging markets is making these geographies strategically important to life sciences organizations and,consistent with their approac
67、h 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 and performance benchma
68、rking.In addition,local players are learning that they need to compete on the basis of improved information and analytics.Growth in Research and Development.Spending trends in research and development are impacted as a result of several factors,including major biopharmaceutical companies efforts to
69、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 270 new molecular entities(“NMEs”)are e
70、xpected to be approved between 2020 and 2024,compared to 236 between 2015 and 2019,and 200 between 2010 and 2014.We believe that further research and development spending,combined with the continued need for cost efficiency across the healthcare landscape,will continue to create opportunities for bi
71、opharmaceutical 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.7Increased Complexity in Research and Development.Biopharmaceutical companies fac
72、e 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 have led to more compl
73、ex development and regulatory pathways.We believe that our global clinical development capabilities,including our expertise in biomarkers and genomics and our global laboratory network,position us well to help biopharmaceutical companies manage the complexities inherent in an environment where this
74、type of expertise is important.For example,the IQVIA CORE helps us validate protocols to ensure studies in new disease areas have greater accuracy and also enables us,through innovations such as predictive analytics,to find patients who may not have been diagnosed.Regulators require clinical trials
75、involving local populations as part of the process for approving new pharmaceutical 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 g
76、eographies will be important to pharmaceutical product growth strategies,both for 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 biopharma
77、ceutical companies managing the complexities of international drug development.Financial 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 chang
78、ing product mix,pricing and reimbursement challenges,and rising costs of compliance.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 comp
79、anies to maximize productivity and lower costs across their processes from research and development through commercial operations will cause them to look to partners as they enter into outsourcing arrangements to improve efficiency.Further,our clients are looking for new ways to simplify processes a
80、nd drive operational efficiencies by using automation,consolidating vendors and adopting 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-co
81、st options that lower clients research and development,selling,marketing and administrative 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 e
82、nhance access to data,relevant information is often unintegrated,unstructured,siloed 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 diagnos
83、tic technologies are creating new sources of healthcare data.In order to derive valuable insights from existing and expanding sources of information,clients need access to statistically significant data sets organized into databases that can be queried and analyzed.For example,real-world evidence st
84、udies demonstrate practical and clinical efficacies,which we believe require the aggregation 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
85、 laboratory test results to identify types of patients that will likely best respond to particular therapies.Finally,manufacturers also require the ability to analyze social media activity to identify unmet patient needs and support for new orphan drugs.This information is highly relevant to all hea
86、lthcare stakeholders and we believe the opportunity to more broadly apply healthcare 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 healt
87、hcare industry are focused on improving quality and reducing costs,both of which require assessment of quality and value of therapies and providers.As a result,physicians no longer make prescribing decisions in isolation,but rather in the context of guidance and rules from payers,integrated delivery
88、 networks and governments.We believe life sciences companies are working to bring alignment across constituents on the value of their treatments in order to successfully develop and commercialize new therapies.There is increasing pressure on life sciences companies to support and justify the value o
89、f their therapies.Many new drugs that are being approved are more expensive than existing therapies and will likely receive heightened scrutiny by regulators and payers to determine whether the existing treatment options would be sufficient.Additionally,many new specialty drugs are molecular-based t
90、herapies and require a more detailed understanding of clinical factors and influencers that demonstrate therapeutic value.As a result,leading life sciences companies are utilizing more sophisticated outcome research and data analytics services.8We believe we are well positioned to take advantage of
91、these global trends in healthcare.Beyond our proprietary information assets,we have 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-dri
92、ven decision-making and cost-efficient technology solutions.Our Growth Strategy We believe we are well positioned for continued growth across the markets we serve.Our strategy for achieving growth includes:Continue to innovate by leveraging our information,advanced analytics,transformative technolog
93、y and significant domain expertise.As a leader in the development and commercialization of new pharmaceutical 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 an
94、d outcomes on more than 800 million non-identified patients.By integrating these capabilities in the IQVIA CORE,we have the ability to optimize the clinical trial process and enable our clients to reduce costs and get their products to market more quickly through more informed site selection,faster
95、patient recruitment practices and virtual trials.We transform Real World Evidence by linking prospective and retrospective approaches and introduce innovation such as secondary control arms,which eliminate the need for a placebo group.We bring best in class SaaS platforms,purpose built for life scie
96、nces,to our clients to help them run their clinical and commercial operations more efficiently.Build upon our extensive client relationships.We have a diversified base of over 8,000 clients in over 100 countries and have expanded our client value proposition to address a broader market for research
97、and development and commercial operations which we estimate to be more than$230 billion in 2019.Through the combined offerings of research and development and commercial services we built a platform that allows us to be a more complete partner to our clients.Expand portfolio through strategic acquis
98、itions.We have and expect to continue to acquire assets and businesses that strengthen our value proposition to clients.We have developed an internal capability to source,evaluate and integrate acquisitions that have created value for stockholders.As the global healthcare landscape evolves,we expect
99、 that there will be a growing number of acquisition opportunities across the life sciences,payer and provider sectors.We expect to continue to invest in or explore opportunities for strategic acquisitions to grow our platform and enhance our ability to provide more services to our clients.Expand the
100、 penetration of our offerings to the broader healthcare marketplace.We believe that substantial opportunities exist to use our existing technology and domain expertise to serve additional healthcare stakeholders(payers,providers,healthcare professionals)to quantify and optimize cost of care delivery
101、;provide registry technology to professional association and patient communities and support healthcare providers with system implementation and platform migration.Our Offerings We offer hundreds of distinct services,applications,technology platforms and solutions to help our clients make critical d
102、ecisions and perform better.We have three operating segments:Technology&Analytics Solutions,Research&Development Solutions and Contract Sales&Medical Solutions.Their offerings complement each other and can provide enhanced value to our clients when delivered together,with each driving demand for the
103、 other.Our Technology&Analytics Solutions offerings include:Technology platforms.We provide an extensive range of cloud-based applications and associated implementation services.Software as a Service(“SaaS”)solutions that support a wide range of clinical and commercial processes,including clinical t
104、rial design and planning,site start-up,patient consent,site payments,content management,multi-channel marketing,real-world evidence generation,customer relationship management(“CRM”),performance management,incentive compensation,territory alignment,roster management,call planning,compliance and safe
105、ty 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.Using proprietary algorithms,we combine our country-level data,heal
106、thcare 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 market dynamics and are used by most large pharmaceutical companies
107、.Real World Solutions.We enable life sciences and provider customers to generate and disseminate evidence in a cost-efficient manner which informs health care decision making and ultimately improves patients outcomes.Our use of a wide range of privacy and security safeguards protect non-identified p
108、atient-level medical claims,prescriptions,electronic medical records,genomics,9patient reported outcome and social media data.Our scaled information networks include more than 800 million non-identified patients globally.We technology-enable these data flows by harmonizing them to common data models
109、 and loading them onto our proprietary evidence platforms for secure access by our customers.We provide access to deep clinical data in Oncology,Rare Disease,and other specialty areas.Our Natural Language Processing capabilities help us create structured data from unstructured clinical notes.We help
110、 our global customers across payers,providers,governments,and biopharmaceutical companies to answer critical questions about healthcare interventions related to safety,effectiveness,and value.We also bring together stakeholders across healthcare to collaborate in efforts to develop new information s
111、ources,more effective reimbursement models,and better patient outcomes.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 commercial operations of life sci
112、ences 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 leverage local market knowle
113、dge,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.Information offerings.Our national offerings comprise unique services in
114、over 100 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.Our sub-national offerings comprise unique services
115、 in over 70 countries 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).Our widely used reference database that tracks approximately 20 million healthcare professionals in o
116、ver 100 countries,providing a comprehensive view of health care practitioners that is critical for the commercial success of our clients marketing and sales initiatives.Our Research&Development Solutions offerings include:Project Management and Clinical Monitoring.Drawing upon our years of experienc
117、e,our site databases,our site relationships and our highly trained staff,our solutions and services enables the efficient conduct and coordination of multi-site clinical trials(generally Phase II-IV).Our service offerings include protocol design,feasibility and operational planning,site start up,pat
118、ient recruitment and clinical site monitoring.By infusing technology into field-based monitoring,we are able to reduce data collection steps and time.Clinical Trial Support Services.Each clinical trial requires a number of concurrent services and data streams.We offer a broad range of functional ser
119、vices and consultation to support clinical trials through specialized expertise that help clients efficiently collect,analyze and report the quality data and evidence they need to gain regulatory approval.Q2 Solutions.We provide our clients globally scaled end-to-end clinical trial laboratory and re
120、search services through our majority-owned joint venture with Quest Diagnostics Incorporated(“Quest”),which was formed on July 1,2015.We offer the full range of central laboratory,genomic,bioanalytical,ADME,discovery,vaccine and biomarker laboratory services along with sample and consent tracking se
121、rvices supporting clinical trials offerings within the joint venture,which is referred to as Q2 Solutions.Strategic Planning and Design.By bringing our data science capabilities to our strategic planning and design services,we offer consultation services to improve decisions and performance includin
122、g portfolio,program and protocol planning and design,biomarker consultation,benefit-risk management,regulatory affairs,biostatistics,modeling and simulation,and personalized medicine.Virtual Trials.Utilizing our proprietary information assets and transformative technology,we bring trials directly to
123、 patients,with the objective of increasing participation and improving cycle times.Combining this with purpose-built processes and industry-leading clinical capabilities,we help clients reach diverse and difficult to recruit patient populations.Our principal Contract Sales&Medical Solutions offering
124、s include:Health Care Provider Engagement Services.We partner with biopharmaceutical companies and other life sciences providers(e.g.,medical device companies)to develop and deploy tailored stakeholder engagement solutions,including contract sales and market access professionals,which are focused on
125、 product sales and improving brand value at all stages of the product lifecycle from initial market entry to brands nearing patent expiry.Patient Engagement Services.Our nurse-based programs directly engage with patients to help improve their disease and medication understanding through intervention
126、al and non-interventional support,while also providing assistance in navigating complex reimbursement coverage issues.Our patient engagement services combine insight from clinical trials and social listening,10behavioral design,personal and innovative eHealth multichannel interactions across multipl
127、e sites(e.g.,the physicians office,hospital,pharmacy,home),that act as an extension of the Health Care Provider prescribed treatment course which can lead to improved adherence and better overall outcomes.Medical Affairs Services.We provide a range of scientific strategy and medical affairs services
128、 to help biopharmaceutical companies plan and transition from the clinical trial setting to commercialization.Beginning in the clinical trial stage,our services can deploy educators to clinical trial sites to accelerate patient recruitment and improve retention,assist in translation of complex clini
129、cal trial data into a compelling scientific platform and publication strategy,and,provide field medical teams to facilitate scientific engagement with key opinion leaders and healthcare decision makers,before and after product approval.Our Clients Sales to companies in life sciences,including pharma
130、ceutical companies,biotechnology companies,device and diagnostic companies,and consumer health companies,accounted for the majority of our revenues.Nearly all of the top 100 global pharmaceutical and biotechnology companies,measured by revenue,are clients,and many of these companies subscribe to rep
131、orts and services in many countries.Other clients include payers,government and regulatory agencies,providers,pharmaceutical distributors,and pharmacies.Our client base is broad in scope and enables us to avoid dependence on any single client.No single client accounted for 10%or more of our total co
132、mpany revenues in 2019,2018 or 2017.As of December 31,2019 the largest client based on its percentage of total company revenue contributed approximately 5%.Our Competition Our Technology&Analytics Solutions business competes with a broad and diverse set of businesses.While we believe no competitor p
133、rovides 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 as with the in-house capabilities of our clients.Also,we compete with certain gove
134、rnment 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 marketplace as well.Our offerings compete with various firms,including Accenture,Aetion
135、,Boston Health Economics,Cognizant Technology Solutions,Covance Inc.,Deloitte,Evidera,(now part of PPD),GfK,LexisNexis Risk Solutions,IBM,Infosys,Kantar Health,McKinsey,Nielsen,OptumInsight,PAREXEL International Corporation,Press Ganey,RTI Health Solutions,PRA Health Sciences,Tempus,Veeva,and ZS Ass
136、ociates.We also compete with a broad range of new entrants and start-ups that are looking to bring new technologies and business models to healthcare information services and technology services.The markets for Research&Development Solutions offerings are highly competitive,and we compete against tr
137、aditional contract research organizations(“CROs”),the in-house research and development departments of biopharmaceutical companies,universities,and teaching hospitals.Among the traditional CROs,there are several-hundred small,limited-service providers,several medium-sized firms and only a few full-s
138、ervice companies with global capabilities.Our primary competitors include Covance Inc.,ICON plc,PAREXEL International Corporation,Pharmaceutical Product Development,Inc.,PRA Health Sciences,and Syneos Health,among others.Our Contract Sales&Medical Solutions business competes against the in-house sal
139、es and marketing departments of biopharmaceutical companies,other contract pharmaceutical sales and service organizations and consulting firms.Contract Sales&Medical Solutions primary competitor in the United States is Syneos Health,Publicis and United Drug plc.Outside of the United States,Contract
140、Sales&Medical Solutions typically competes against single country or more regionally focused service providers,such as United Drug plc,Syneos Health,EPS Corporation and CMIC HOLDINGS Co.,Ltd.Government Regulation Many aspects of our businesses are regulated by federal and state laws,rules and regula
141、tions.Accordingly,we maintain a robust compliance program aimed at ensuring we operate our business in compliance with all existing legal requirements material to the operation of our businesses.There are,however,occasionally uncertainties involving the application of various legal requirements,the
142、violation of which could result in,among other things,fines or other sanctions.See Part I,Item 1A,Risk Factors”for additional detail.Good Clinical Practice Good Clinical Practice(“GCP”)regulations and guidelines are the industry standard for the conduct of clinical trials with respect to maintaining
143、 the integrity of the data and safety of the research subjects.The United States Food and Drug Administration(“FDA”),the European Medicines Agency(“EMA”),Japans Ministry of Health,Labour and Welfare and most other global 11regulatory authorities expect that study results and data submitted to such a
144、uthorities be based on clinical trials conducted in accordance with GCP provisions.Records for clinical trials must be maintained for specified periods for inspection by the FDA and other regulators.Regulation of Drugs,Biologics and Medical Devices In the United States,pharmaceutical,biological and
145、medical device products are subject to extensive regulation by the FDA.The Federal Food,Drug,and Cosmetic Act(“FDC Act”),the Public Health Service Act(“PHS Act”),and other federal and state statutes and regulations,govern,among other things,the research,development,testing,manufacture,storage,record
146、keeping,approval,labeling,promotion and marketing,distribution,post-approval monitoring and reporting,sampling,and import and export of pharmaceutical,biological and medical device products.Failure to comply with applicable United States requirements may subject a company to a variety of administrat
147、ive or judicial sanctions,such as FDA refusal to approve a pending new drug application(“NDA”)for a new drug,a biologics license application(“BLA”)for a new biological product pre-market approval(“PMA”)or clearance for a new medical device,warning or untitled letters,clinical holds,product recalls,p
148、roduct 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 the processing of information regarding patient diagnosis and treatment of disease and
149、are,therefore,subject to substantial governmental regulation.In addition,the confidentiality of patient-specific information and the circumstances under which such patient-specific records may be released for inclusion in our databases or used in other aspects of our business is heavily regulated.Fe
150、deral,state and foreign governments are contemplating or have proposed or adopted additional legislation governing the possession,use and dissemination of personal data,such as personal health information and personal financial data,as well as security breach notification rules for loss or theft of
151、such data.Additional legislation or regulation of this type might,among other things,require us to implement additional security measures and processes or bring within the legislation or regulation de-identified health or other data,each of which may require substantial expenditures or limit our abi
152、lity to offer some of our services.In particular,personal health information is recognized in many countries such as the United States,the European Union,or EU,and several countries in Asia,as a special,sensitive category of personal information,subject to additional mandatory protections.Violations
153、 of data protection regulations are subject to administrative penalties,civil money penalties and criminal prosecution,including corporate fines and personal liability.Regulation of Promotion,Marketing and Distribution of Pharmaceutical Products and Medical Devices Certain of our services are subjec
154、t to detailed and comprehensive regulation in each geographic market in which we operate.Such regulation relates,among other things,to the distribution of drug samples,the marketing and promotion of approved products,the qualifications of sales representatives and the use of healthcare professionals
155、 in sales functions.In the United States,certain of our services are subject to numerous federal and state laws pertaining to promotional activities involving pharmaceutical products and medical devices.Certain of our services are subject to the FDAs regulations against“off-label promotion,”which re
156、quire sales representatives to restrict promotion of the approved product they are detailing to the approved labeling for the product.The Prescription Drug Marketing Act imposes licensing,personnel record keeping,packaging,labeling,product handling and facility storage and security requirements.Othe
157、r federal and state laws prohibit manufacturers,suppliers and providers from offering,giving or receiving kickbacks or other remuneration in connection with ordering or recommending the purchase or rental of healthcare items and services.The sale or distribution of pharmaceutical products and device
158、s is also governed by the United States Federal Trade Commission Act and state consumer protection laws.We are subject to similar regulations currently in effect in the other countries where we offer Contract Sales&Medical Solutions.We are also subject to various laws and regulations that may apply
159、to certain drug and device promotional practices,including,among others,various aspects of Medicare and federal healthcare programs.Violations of these laws and regulations may result in criminal and/or civil penalties,including possibly as an“aider and abettor.”Regulation of Laboratories Our United
160、 States laboratories are subject to licensing and regulation under federal,state and local laws relating to hazard communication and employee right-to-know regulations,and the safety and health of laboratory employees.Additionally,our United States laboratories are subject to applicable federal and
161、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 12Environmental Protection Agency,the Nuclear Regulatory Commission,the Department of Transportation,
162、the National Fire Protection Agency and the United States Drug Enforcement Administration(“DEA”).The use of controlled substances in testing for drugs with a potential for abuse is regulated in the United States by the DEA and by similar regulatory bodies in other parts of the world.Our United State
163、s laboratories using controlled substances for testing purposes are licensed by the DEA.The regulations of the United States Department of Transportation,Public Health Service and Postal Service apply to the surface and air transportation of laboratory specimens.Our laboratories also are subject to
164、International Air Transport Association regulations,which govern international shipments of laboratory specimens.Furthermore,when the materials are sent to a foreign country,the transportation of such materials becomes subject to the laws,rules and regulations of such foreign country.Our laboratorie
165、s outside the United States are subject to applicable national laws governing matters such as licensing,the handling and disposal of medical specimens,genetic material,hazardous waste and radioactive materials,as well as the health and safety of laboratory employees.In addition to its comprehensive
166、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 to blood-borne pathogens such as HIV and the hepatitis B virus.Although we b
167、elieve 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 and other enforcement actions.Further,laboratories that analyze human blood
168、 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 meet these requirements may result in civil penalties and suspension or rev
169、ocation 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 intellectual property in the conduct of our business.We rely upon a combination of le
170、gal,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 trademark and related names,marks and logos to be of material importance to our
171、business,and we have registered or applied for registration for certain of these trademarks including IQVIA,in the United States and other jurisdictions and aggressively seek to protect them.Trademarks and service marks generally may be renewed indefinitely so long as they are in use and/or their re
172、gistrations are properly maintained,and so long as they have not been found to have become generic.The technology and other intellectual property rights owned and licensed by us are of importance to our business,although our management believes that our business,as a whole,is not dependent upon any
173、one intellectual property or group of such properties.Our Employees As of December 31,2019,we have approximately 67,000 employees worldwide.Almost all of these employees are full-time.None of our employees are covered by a collective bargaining agreement or are represented by a labor union.Employees
174、 in certain locations outside of the United States are represented by works councils as required by local laws.Available Information Our website address is ,and our investor relations website is located at http:/.Information on our website is not incorporated by reference herein.Copies of our annual
175、 reports on Form 10-K,quarterly reports on Form 10-Q,current reports on Form 8-K and our Proxy Statements for our annual meetings of stockholders,and any amendments to those reports,as well as Section 16 reports filed by our insiders,are available free of charge on our website as soon as reasonably
176、practicable after we file the reports with,or furnish the reports to,the Securities and Exchange Commission(“SEC”).In addition,the SEC maintains an Internet site(http:/www.sec.gov)containing reports,proxy and information statements,and other information regarding issuers that file electronically wit
177、h 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 Committee and Nominating and Governance Committee,our Corporate G
178、overnance 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 Department.Within the time period required by the SEC and th
179、e New York Stock Exchange(“NYSE”),we will post on our website any amendment to the Code of Conduct or any waiver of such policy applicable to any of our senior financial officers,executive officers or directors.13Item 1A.Risk FactorsRISK FACTORSWe operate in a rapidly changing environment that invol
180、ves a number of risks,some of which are beyond our control.You should consider carefully the risks and uncertainties described below together with the other information included in this Annual Report on Form 10-K,including our consolidated financial statements and related notes included elsewhere in
181、 this Annual Report on Form 10-K,in evaluating our Company.The occurrence of any of the following risks may materially and adversely affect our business,financial condition,results of operations and future prospects.Risks Relating to Our Business The potential loss or delay of our large contracts or
182、 of multiple contracts could adversely affect our results.Most of our Research&Development Solutions clients can terminate our contracts upon 30 to 90 days notice.Our clients may delay,terminate or reduce the scope of our contracts for a variety of reasons beyond our control,including but not limite
183、d to:decisions to forego or terminate a particular clinical trial;lack of available financing,budgetary limits or changing priorities;actions by regulatory authorities;production problems resulting in shortages of the drug being tested;failure of products being tested to satisfy safety requirements
184、or efficacy criteria;unexpected or undesired clinical results for products;insufficient patient enrollment in a clinical trial;insufficient investigator recruitment;shift of business to a competitor or internal resources;product withdrawal following market launch;or shut down of manufacturing facili
185、ties.As a result,contract terminations,delays and alterations are a regular part of our Research&Development Solutions business.In the event of termination,our contracts often provide for fees for winding down the project,but these fees may not be sufficient for us to realize the full amount of reve
186、nues or profits anticipated under the related services contracts,and termination may result in lower resource utilization rates.In addition,we will not realize the full benefits of our backlog of contractually committed services if our clients cancel,delay or reduce their commitments under our contr
187、acts with them,which may occur if,among other things,a client decides to shift its business to a competitor or revoke our status as a preferred provider.Thus,the loss or delay of a large contract or the loss or delay of multiple contracts could adversely affect our revenues and profitability.We beli
188、eve 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.14 We depend on third parties for data and support services.Our suppliers or providers might restrict our use of or refuse
189、to license data or provide services,which could lead to our inability to access certain data or provide certain services and,as a result,materially and adversely affect our operating results and financial condition.Each of our Technology&Analytics Solutions information services is derived from data
190、we collect from third parties.These data suppliers are numerous and diverse,reflecting the broad scope of information that we collect and use in our business.Although we typically enter into long-term contractual arrangements with many of these suppliers of data,at the time of entry into a new contr
191、act or renewal of an existing contract,suppliers may increase restrictions on our use of such data,increase the price they charge us for data or refuse altogether to license the data to us.In addition,during the term of any data supply contract,suppliers may fail to adhere to our data quality contro
192、l standards or fail to deliver data.Further,although no single individual data supplier is material to our business,if a number of suppliers collectively representing a significant amount of data that we use for one or more of our services were to impose additional contractual restrictions on our us
193、e of or access to data,fail to adhere to our quality-control standards,repeatedly fail to deliver data or refuse to provide data,now or in the future,our ability to provide those services to our clients could be materially adversely impacted,which may harm our operating results and financial conditi
194、on.Additionally,we depend on third parties for support services to our business.Such support services include,but are not limited to,third-party transportation providers,suppliers of drugs for patients participating in clinical trials,suppliers of kits for use in our clinical trial laboratories busi
195、ness,suppliers of reagents for use in our testing equipment and providers of maintenance contracts for our equipment.The failure of any of these third parties to adequately provide the critical support services could have a material adverse effect on our business.If we fail to perform our services i
196、n accordance with contractual requirements,regulatory standards and ethical considerations,we could be subject to significant costs or liability and our reputation could be harmed.We contract with biopharmaceutical companies to perform a wide range of services to assist them in bringing new drugs to
197、 market.Our services include monitoring clinical trials,data and laboratory analysis,electronic data capture,patient recruitment and other related services,and we perform these services in a number of ways,including through physical and technology-enabled efforts.Such services are complex and subjec
198、t to contractual requirements,regulatory standards and ethical considerations.For example,we must adhere to regulatory requirements such as the FDA and current GCP and Good Laboratory Practice requirements.If we fail to perform our services in accordance with these requirements,regulatory agencies m
199、ay take action against us for failure to comply with applicable regulations governing clinical trials or sales and marketing practices.Such actions may include sanctions,such as injunctions or failure of such regulatory authorities to grant marketing approval of products,delay,suspension or withdraw
200、al of approvals,license revocation,product seizures or recalls,operational restrictions,civil or criminal penalties or prosecutions,damages or fines.Clients may also bring claims against us for breach of our contractual obligations and patients in the clinical trials and patients taking drugs approv
201、ed on the basis of those clinical trials may bring personal injury claims against us for negligence.Any such action could have a material adverse effect on our results of operations,financial condition and reputation.Such consequences could arise if,among other things,the following occur:Improper pe
202、rformance 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 repor
203、ted improperly.If the clinical trial results are compromised,we could be subject to significant costs or liability,which could have an adverse impact on our ability to perform our services.As examples:non-compliance generally could result in the termination of ongoing clinical trials or sales and ma
204、rketing 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
205、 further cost to our client,but at a substantial cost to us;and breach of a contractual term could result in liability for damages or termination of the contract.Large clinical trials can cost up to hundreds of millions of dollars,and while we endeavor to contractually limit our exposure to such ris
206、ks,improper performance of our services could have an adverse effect on our financial condition,damage our reputation and result in the cancellation of current contracts by or failure to obtain future contracts from the affected client or other clients.15Investigation of clients.From time to time,on
207、e or more of our clients are audited or investigated by regulatory authorities or enforcement agencies with respect to regulatory compliance of their clinical trials,programs or the marketing and sale of their drugs.In these situations,we have often provided services to our clients with respect to t
208、he clinical trials,programs or activities being audited or investigated,and we are called upon to respond to requests for information by the authorities and agencies.There is a risk that either our clients or regulatory authorities could claim that we performed our services improperly or that we are
209、 responsible for clinical trial or program compliance.If our clients or regulatory authorities make such claims against us and prove them,we could be subject to damages,fines or penalties.In addition,negative publicity regarding regulatory compliance of our clients clinical trials,programs or drugs
210、could have an adverse effect on our business and reputation.Insufficient client funding to complete a clinical trial.As noted above,clinical trials can cost hundreds of millions of dollars.There is a risk that we may initiate a clinical trial for a client,and then the client becomes unwilling or una
211、ble to fund the completion of the clinical trial.In such a situation,notwithstanding the clients ability or willingness to pay for or otherwise facilitate the completion of the clinical trial,we may be ethically bound to complete or wind down the clinical trial at our own expense.Security breaches a
212、nd unauthorized use of our IT systems and information,or the IT systems or information in the possession of our vendors,could expose us,our clients,our data suppliers or others to risk of loss.We rely upon the security of our computer and communications systems infrastructure to protect us from cybe
213、rattacks 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
214、our systems,as cyber threats evolve and become more difficult to detect and successfully defend against,one or more cyber threats might defeat the measures that we or our vendors take to anticipate,detect,avoid or mitigate such threats.Certain techniques used to obtain unauthorized access,introduce
215、malicious software,disable or degrade service,or sabotage systems may be designed to remain dormant until a triggering event and we may be unable to anticipate these techniques or implement adequate preventative measures since techniques change frequently or are not recognized until launched,and bec
216、ause cyberattacks can originate from a wide variety of sources.Although we take steps to manage and avoid these risks and to prevent their recurrence,our preventive and remedial actions may not be successful.Such attacks,whether successful or unsuccessful,could result in our incurring costs related
217、to,for example,rebuilding internal systems,defending against litigation,responding to regulatory inquiries or actions,paying damages or fines,or taking other remedial steps with respect to third parties.Publicity about vulnerabilities and attempted or successful incursions could damage our reputatio
218、n with clients and data suppliers and reduce demand for our services.We also store proprietary and sensitive information in connection with our business,which could be compromised by a cyberattack.To the extent that any disruption or security breach results in a loss or damage to our data,an inappro
219、priate disclosure of proprietary or sensitive information,an inability to access data sources,or an inability to process data or provide our offerings to our clients,it could cause significant damage to our reputation,affect our relationships with our data suppliers and clients(including loss of sup
220、pliers and clients),lead to claims against us and ultimately harm our business.We may be required to incur significant costs to alleviate,remedy or protect against damage caused by these disruptions or security breaches in the future.We may also face inquiry or increased scrutiny from government age
221、ncies as a result of any such disruption or breach.While we have insurance coverage for certain instances of a cyber security breach,our coverage may not be sufficient if we suffer a significant attack or multiple attacks.Any such breach or disruption could have a material adverse effect on our oper
222、ating results and our reputation as a provider of mission-critical services.Some of our vendors have significant responsibility for the security of certain of our data centers and computer-based platforms.Also,our data suppliers have responsibility for security of their own computer and communicatio
223、ns environments.These third parties face risks relating to cyber security similar to ours,which could disrupt their businesses and therefore materially impact ours.Accordingly,we are subject to any flaw in or breaches to their computer and communications systems or those that they operate for us,whi
224、ch could result in a material adverse effect on our business,operations and financial results.Failure to meet productivity objectives under our internal business transformation initiatives could adversely impact our competitiveness and harm our operating results.We are pursuing business transformati
225、on initiatives to update technology,increase innovation and obtain operating efficiencies.As part of these initiatives,we seek to improve our productivity,flexibility,quality,functionality and cost savings by investing in the development and implementation of global platforms and integration of our
226、business processes and functions to achieve economies of scale.For example,we have assessed our site activation processes and are moving forward with implementing organizational and process changes and technology transformations to accelerate site start-up timelines.We are also evaluating the custom
227、er buying experience,implementing technology platforms to streamline the proposal and contracting process and provide greater transparency to clients.These various initiatives may not yield their intended gains,or be completed in timely manner,which 16may impact our competitiveness and our ability t
228、o meet our growth objectives and,as a result,materially and adversely affect our business,operating results and financial condition.If we are unsuccessful at investing in growth opportunities,our business could be materially and adversely affected.We continue to invest significantly in growth opport
229、unities,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 support commercial operation
230、s 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 growth opportunities in em
231、erging markets,such as the development,launch and enhancement of services in China,India,Russia,Turkey,and other countries.We consider our presence in these markets to be an important component of our growth strategy.There is no assurance that our investment plans or growth strategy will be successf
232、ul 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 technologies and services,our new technologies and services do not work as intended or there are delays in the availability or adoption o
233、f 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 growth in healthcare spending in emerging markets,such spending may occur more slowly or not at all,and we may not benefit from our i
234、nvestments 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 available in sufficient amounts to fund future growth opportunities when needed.Any of the foregoing could have a material and adv
235、erse 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 disclosure of personal information,and failure to comply with or adapt to changes in these laws could materially and adversely harm
236、our business.The confidentiality,collection,use and disclosure of personal data,including individually identifiable health information and clinical trial patient-specific information,are subject to governmental regulation generally in the country that the personal data were collected or used.For exa
237、mple,United States federal regulations under the Health Insurance Portability and Accountability Act of 1996(“HIPAA”)create specific requirements for the protection of the privacy and security of individual health information.These provisions apply to both“covered entities”(primarily health care pro
238、viders 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 can be directly liable for mishandling protected health information.Under HIPAAs enforcement scheme,we can be subject to significa
239、nt penalties in connection with HIPAA violations,along with the potential for significant other expenditures related to these activities.These rules require individuals written authorization in many situations,in addition to any required informed consent,before protected health information may be us
240、ed for research.We are both directly and indirectly affected by the privacy provisions surrounding individual authorizations because many investigators with whom we are involved in clinical trials are directly subject to them as a HIPAA“covered entity”and because we obtain identifiable health inform
241、ation from third parties that are subject to such regulations.In general,patient health information is among the most sensitive(and highly regulated)of personal information and laws and regulations around the United States and the world are designed to ensure that information about an individuals he
242、althcare is properly protected from inappropriate access,use and disclosure.Laws restricting access,use and disclosure of patient health information also include the European Unions(“EU”)General Data Protection Regulation,Canadas Personal Information Protection and Electronic Documents Act and other
243、 data protection,privacy,data security and similar national,state/provincial and local laws.In the EU personal data includes any information that relates to an identified or identifiable natural person with health information carrying additional obligations,including obtaining the explicit consent f
244、rom the individual for collection,use or disclosure of the information.In addition,we are subject to EU rules with respect to cross-border transfers of such data out of the EU(along with similar data transfer requirements or data localization requirements in other countries).The United States,the EU
245、 and its member states,and other countries where we have operations,such as Argentina,Brazil,Canada,Chile,China,Japan,Malaysia,Mexico,Philippines,Russia,Singapore,South Korea and Switzerland,continue to consider or have issued new privacy and data protection rules and regulations that relate to pers
246、onal data and health information.17We 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 worldwide.In addition,we rely on our data suppliers to deliver informatio
247、n 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 sufficient to prevent a breach of these laws,or that claims will not be file
248、d 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 protection and privacy regulations,and similar rules in various jurisdictions,or
249、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 contractual provisions.For example,in July 2015,indictments were issued b
250、y 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 3“Legal Proceedings”for additional information.Laws and expectations rela
251、ting 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 regulations are being enacted.In addition,certain long-established programs have bee
252、n(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 programs may adversely impact our ability to provide services to our clients
253、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 personal health information,and personal financial data as well as security
254、 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 other personal data not currently regulated,each of which may require subst
255、antial 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 disclosure,and may require increased expenditures by us or may dictate th
256、at 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,regulators and others regarding data protection and privacy issues,and the
257、 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 information are sufficient,and the risk of re-identification sufficiently small,to a
258、dequately 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 to access and use data or to develop or market current or future services.D
259、ata 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 information relating to identifiable individuals.Failure to comply with these
260、 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 or may dictate that we not offer certain types of services.The occurrence
261、 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 and financial condition.Our success depends on our ability to protect our i
262、ntellectual 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.We rely upon a combination of trade secrets,confidentiality policies,nondisclosure,invention assignment and
263、 other contractual arrangements,and patent,copyright and trademark laws,to protect our intellectual property rights.These laws are subject to change at any time and certain agreements may not be fully enforceable,which could further restrict our ability to protect our innovations.Further,these laws
264、may not provide adequate protection for our intellectual property,particularly in countries in which the legal system provides less protection for intellectual property rights.Our intellectual property rights may not prevent competitors from independently developing services similar to or duplicativ
265、e 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,and we might not be able to detect unauthorized use of,or take appropriate and timel
266、y steps to enforce,our intellectual property rights.18 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 uncertainty as to the scope of protection,registrability,patentability,validity and enforc
267、eability 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 rights.When we seek to enforce our intellectual property rights,we may be subject t
268、o 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 information.Litigation brought to protect and enforce our intellectual property rights cou
269、ld 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 may be met with defenses,counterclaims and countersuits attacking the validity and
270、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 resources,could delay further sales or the implementation of our solutions,impair
271、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 financial condition.The theft or unauthorized use or publication of our trade secrets
272、 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 make claims against us related to losses of their confidential or proprieta
273、ry 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 value of our proprietary rights or reputation.The protection of our intellectu
274、al 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 infringing or misappropriating our proprietary rights.These incidents and clai
275、ms 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 or our clients infringe their intellectual property rights and these claims,w
276、ith 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 that may limit the operation of our business or prevent the marketing and sell
277、ing 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 costly redesigns to the affected services,or pay damages to satisfy contrac
278、tual 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 and financial condition.In addition,certain contracts with our suppliers or
279、 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 data.Claims made under these provisions could be expensive to litigate and could result in signific
280、ant 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 services rely on technology or intellectual property rights owned and controlled by ot
281、hers.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 these licenses on less advantageous terms,could harm our operating results and f
282、inancial condition.Our 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 Research&Development Solutions contracts are either fee for service contracts or
283、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 successfully negotiate a change order.Change orders typically occur when the scope of
284、 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 significant change in timing.Where we are not successful in converting out-of-scope
285、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 our business,results of operations,financial condition or cash flows.19The relati
286、onship 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 contracts.Once work begins on a project,revenue is recognized over the duration of th
287、e 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 event that a client cancels a contract,we typically would be entitled to receive pay
288、ment 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 revenue reflected in our backlog in the event of a contract cancellation.The dura
289、tion 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 business,and we may not realize all the anticipated future revenue reflected in our b
290、acklog.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 scope of work during the course of a project.Although an increase in backlog wil
291、l 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 increase in revenues during a particular period.The extent to which contracts in backl
292、og 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 and phase of the contracts,each of which factors can vary significantly from ti
293、me 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 variety of reasons,including but not limited to an extended period of negotiation
294、 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 trials and the need to enroll precise patient populations could extend the leng
295、th 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 originally expected.Thus,the relationship of backlog to realized revenues may vary ove
296、r time.Our 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 materially limit our operations.Due to the global nature of our business and our re
297、liance 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 systems to certain of our clients in connection with the services we provide them.As th
298、e 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:disruption,impairment or failure of data centers,telecommunications facilities or
299、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 deficiencies in systems development and deployment.20The materialization of any of
300、 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,confidential or other data.While we have disaster recovery plans in place,they might n
301、ot 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 in the world to avoid disruption in the receipt,processing and delivery of data i
302、n 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 could result in interruptions in the flow of data to our servers and from our ser
303、vers 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 addition,any failure by our computer environment to provide sufficient processing or ne
304、twork 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 server hosting services.Such a transfer could result in significant delays in our
305、 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 and harm our business.Finally,long-term disruptions in the infrastructure caused b
306、y 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 property and business interruption insurance,our coverage might not be adequate to
307、 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 adapt to new processes designed into new or upgraded systems in a timely and cost-ef
308、fective 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 license to us the IT platform for programs to optimize our business processes.If s
309、uch 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 investments,internally or with third parties,to achieve our objectives.Additionally,our p
310、rogress 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 may not take place as we anticipate,including obtaining adequate technology-enabl
311、ed 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 profitability.We may experience challenges with the acquisition,development,enhancement or
312、 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,statistical projections and forecasting,mobile computing,social media analytics and
313、other applications and technologies,particularly in our Technology&Analytics Solutions and Research&Development Solutions businesses.We seek to address our technology risks by increasing our reliance on the use of innovations by cross-industry technology leaders and adapt these for our biopharmaceut
314、ical 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 clients in forms that are easy to
315、 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 needs or those of our clients needs or achieve expected investment goals,or that we will be
316、 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 will depen
317、d 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 prevent th
318、e successful design,development,testing,introduction or marketing of our services.New services,or enhancements to existing services,may not adequately meet our own requirements or those of current and prospective clients or achieve any degree of significant market acceptance.These types of failures
319、could have a material adverse effect on our operating results,financial condition and reputation.21Consolidation 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 opera
320、ting results and 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 comb
321、ined entity,leading 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 di
322、scontinue or reduce 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
323、 therapeutic concentration.Although we did not have any client that represented 10%or more of our revenues in 2019,2018 and 2017,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 operatio
324、ns or financial 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 o
325、r all of the clinical 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 com
326、panies with similar 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.Our business is subject to intern
327、ational economic,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 operat
328、ions in locations 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 wh
329、ich we are subject in the United States or which may change unexpectedly;for example,conducting a single clinical trial across multiple countries is complex,and issues in one country,such as a failure to comply with local regulations or restrictions,may affect the progress of the clinical trial in t
330、he other countries,for example,by limiting the amount of data necessary for a clinical trial to proceed,resulting in delays or potential cancellation of contracts,which in turn may result in loss of revenue;the United States or foreign countries could enact legislation or impose regulations or other
331、 restrictions,including unfavorable labor regulations,tax policies or economic sanctions,which could have an adverse effect on our ability to conduct business in or expatriate profits from the countries in which we operate,including hiring,retaining and overseeing qualified management personnel for
332、managing operations in multiple countries,differing employment practices and labor issues,and tax-related risks,including the imposition of taxes and the lack of beneficial treaties,that result in a higher effective tax rate for us;foreign countries are expanding or may expand their regulatory frame
333、work with respect to patient informed consent,protection and compensation in clinical trials,which could delay or inhibit our ability to conduct clinical trials in such jurisdictions;the regulatory or judicial authorities of foreign countries may not enforce legal rights and recognize business procedures in a manner in which we are accustomed or would reasonably expect;local,economic,political and
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