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Our suppliers or providers might restrict our use of or refuse to license data or provide services, which could lead to our inability to access certain data or provide certain services and, as a result, materially and adversely affect our operating results and financial condition.
−Removed: Each of our Technology & Analytics Solutions information services is derived from data we collect from third parties.
+Added: Our Commercial Solutions information services are derived from data we collect from third parties.
These data suppliers are numerous and diverse, reflecting the broad scope of information that we collect and use in our business.
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Third parties may attempt to improperly persuade customers, suppliers, vendors, partners, employees or others to disclose sensitive information such as user names, passwords or other information that can be used to gain unauthorized access to systems or data.
−Removed: Cyber threats are rapidly evolving and are becoming increasingly sophisticated.
+Added: Cyber threats are rapidly evolving and are becoming increasingly sophisticated, including through the use of AI-supported attacks.
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 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 because cyberattacks can originate from a wide variety of sources.
−Removed: Our preventive and remedial actions may not be successful.
+Added: Our preventive and remedial actions, including the activities described in Item 1C Cybersecurity in this Annual Report on Form 10-K, may not be successful.
We have acquired various companies, products, services and technologies over the years.
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Failure to meet productivity objectives under our internal business transformation initiatives could adversely impact our competitiveness and harm our operating results.
−Removed: We are pursuing business transformation initiatives to update technology, increase innovation and obtain operating efficiencies.
+Added: We are pursuing business transformation initiatives to update technology, increase innovation and obtain operating efficiencies, including through the use of AI.
As part of these initiatives, which include accelerating site start-up timelines and improving our customer buying experience, we seek to improve our productivity, flexibility, quality, functionality and cost savings by investing in the development and implementation of global platforms and integration of our business processes and functions to achieve economies of scale.
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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 and clinical operations for life sciences companies (e.g., multi-channel marketing, marketing campaign management, customer relationship management, incentive compensation management, targeting and segmentation, performance management, site engagement payments, trial master file, risk based monitoring, in-home nursing and other services, clinical trial management and decentralized trials and other applications).
+Added: We are also investing significantly in our AI strategy by launching AI-enabled solutions across our business units, developing AI agents for internal use and external offerings, and developing relationships with key strategic partners across the health-tech sector to foster collaboration and facilitate interoperability amongst AI-enabled solutions.
We also continue to invest significantly in growth opportunities in emerging markets, such as the development, launch and enhancement of services in China, India, Turkey, and other countries.
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There is no assurance that our investment plans or growth strategy will be successful or will produce a sufficient or any return on our investments.
−Removed: Further, if we are unable to develop new technologies and services, clients do not purchase our new technologies and services, our new technologies and services do not work as intended or there are delays in the availability or adoption of our new technologies and services, then we may not be able to grow our business or growth may occur slower than anticipated.
+Added: Further, if we are unable to develop new technologies and services or keep up with the rapid pace of change in technological development and innovation, clients do not purchase our new technologies and services, our new technologies and services do not work as intended or there are delays in the availability or adoption of our new technologies and 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 investments in these markets.
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Any of the foregoing could have a material and adverse effect on our operating results and financial condition.
−Removed: Data protection, privacy and similar laws in the United States and around the world restrict access, use and disclosure of personal information, and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.
−Removed: The confidentiality, collection, use, retention, security, transfer 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 (collectively, "Privacy Laws").
−Removed: For example, United States federal regulations under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) create specific requirements for the protection of the privacy and security of individual health information.
−Removed: These provisions apply to both “covered entities” (primarily health care providers and health insurers) and their “business associates” or service providers.
−Removed: 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.
−Removed: Under HIPAA’s enforcement scheme, we can be subject to significant penalties in connection with HIPAA violations, along with the potential for significant other expenditures related to these activities.
−Removed: These rules require individuals’ written authorization in many situations, in addition to any required informed consent, before protected health information may be used for research.
−Removed: 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 and because we obtain identifiable health information from third parties that are subject to such various Privacy Laws.
−Removed: In general, patient health information is among the most sensitive (and highly regulated) of personal information.
−Removed: Privacy Laws in the United States and around the world are designed to ensure that information about an individual’s healthcare is properly protected from inappropriate access, use and disclosure.
−Removed: Privacy Laws also include the European Union’s (“EU”) General Data Protection Regulation, Canada’s Personal Information Protection and Electronic Documents Act and other data protection, privacy, data security, data localization and similar national, state/provincial and local laws.
−Removed: In the EU and in many other regions or countries, personal data includes any information that relates to an identifiable natural person.
−Removed: Health information about an identifiable person carries additional obligations under these laws, including obtaining the explicit consent from the individual for collection, use or disclosure of the information.
−Removed: 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).
−Removed: We have established frameworks, models, processes and technologies to manage privacy and security for many data types, from a variety of sources, and under a myriad of Privacy Laws.
−Removed: In addition, we rely on our data suppliers to deliver information to us in a form and in a manner that complies with applicable Privacy Laws.
−Removed: These laws are complex and there is no assurance that the safeguards and controls employed by us or our data suppliers will be sufficient to prevent a breach of these laws, or that claims will not be filed against us or our data suppliers despite such safeguards and controls.
+Added: Data protection, privacy and similar laws and regulations in the United States and around the world restrict access, use and disclosure of personal information, and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.
+Added: The confidentiality, collection, use, retention, security, transfer and disclosure of personal information is subject to governmental regulation in the countries where the personal information was collected or processed.
+Added: For example, United States federal regulations under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) create specific requirements for the protection of the privacy and security of certain individually-identifiable health information, specifically protected health information (PHI).
+Added: These provisions apply to both “covered entities” (health care providers, health care plans, and clearinghouses) and their “business associates” (service providers who process PHI on behalf of the covered entity).
+Added: When acting as a HIPAA covered entity or as a business associate of a covered entity, there can be liability for improper processing of PHI.
+Added: Under HIPAA’s enforcement scheme, overseen by the US Department of Health and Human Services, covered entities and business associates may be subject to significant penalties and fines in connection with HIPAA violations, along with the potential for significant other expenditures related to these activities.
+Added: Privacy laws and regulations in all regions of the world are designed to ensure that information about an individual is properly protected from inappropriate access, use and disclosure.
+Added: Such laws and regulations also include the European Union’s (“EU”) General Data Protection Regulation (GDPR), Canada’s Personal Information Protection and Electronic Documents Act (PIPEDA), Brazil’s General Data Protection Law (LGPR), India’s Digital Personal Data Protection Act (DPDP Act), Japan’s Act on the Protection of Personal Information (APPI), China’s Personal Information Protection Law (PIPL) and many other data protection and privacy laws at the national, state/provincial and local level.
+Added: Under most laws and regulations around the world, any information that relates to an identifiable natural person is considered “personal information”.
+Added: In general, health information related to an identifiable person is considered “sensitive personal information” and is highly regulated.
+Added: Processing health information carries additional obligations under these laws and regulations, often including the need to obtain the explicit consent of the individual for collection, use or disclosure of the information.
+Added: In many countries, there are restrictions related to the cross-border transfer of personal information to other countries, including the need to put measures in place to allow the data transfer to occur.
+Added: For example, registration with the EU-US Data Protection Framework (DPF) allows the transfer of data from the EU to US.
+Added: For companies not registering with the DPF, another means of legalizing the transfer is the use of standard contractual clauses.
+Added: In addition, in several countries around the world there are requirements to maintain personal information or sensitive personal information within that particular country under their data localization laws.
+Added: We have established frameworks, models, processes and technologies to manage privacy, data protection and security for many data types, from a variety of sources, and under a myriad of privacy and data protection laws.
+Added: In addition, we rely on our data suppliers to deliver information to us in a form and in a manner that complies with applicable privacy laws and regulations.
+Added: These laws and regulations 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 regulations, or that claims will not be filed against us or our data suppliers despite such safeguards and controls.
Failure to comply with such laws, certain certification/registration and annual re-certification/registration provisions associated with these data protection and privacy regulations, and similar rules in various jurisdictions, or to resolve any serious privacy complaints, may result in, among other things, regulatory sanctions, criminal prosecution, civil liability, negative publicity, damage to our reputation, or data being blocked from use or liability under contractual provisions.
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Changes to these programs may adversely impact our ability to provide services to our clients or develop new products or services.
−Removed: Federal, state and foreign governments are contemplating or have proposed or adopted new Privacy Laws or modifications to existing Privacy Laws, including by amendment, replacement or interpretation through judicial or administrative decisions.
−Removed: New or modified Privacy Laws might, among other things, require us to implement new security measures and processes or bring within the scope of the Privacy Law other data not currently regulated, each of which may require substantial expenditures or limit our ability to offer some of our services.
−Removed: Additionally, changes in Privacy Laws may limit our data access, use and disclosure, and may require increased expenditures by us or may dictate that we not offer certain types of services.
+Added: Federal, state and foreign governments are contemplating or have proposed or adopted new privacy laws and regulations or modifications to existing privacy laws and regulations, including by amendment, replacement or interpretation through judicial or administrative decisions.
+Added: New or modified privacy laws or regulations might, among other things, require us to implement new security measures and processes or bring within the scope of the privacy law or regulation other data not currently regulated, each of which may require substantial expenditures or limit our ability to offer some of our services.
+Added: Additionally, changes in privacy laws and regulations may limit our data access, use and disclosure, and may require increased expenditures by us or may dictate that we not offer certain types of services.
Any of the foregoing may have a material adverse impact on our ability to provide services to our clients or maintain our profitability.
−Removed: There is ongoing concern from privacy advocates, regulators and others regarding data protection and privacy issues, and the number of jurisdictions with Privacy Laws has been increasing.
−Removed: 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 adequately protect patient privacy.
+Added: There is ongoing concern from privacy advocates, regulators and others regarding data protection and privacy issues, and the number of jurisdictions with privacy laws and regulations has been increasing.
+Added: Also, there are ongoing public policy discussions and legal challenges regarding whether the standards for de-identified, anonymous or pseudonymized health information are sufficient, and the risk of re-identification sufficiently small, to adequately protect patient privacy.
These discussions may lead to further restrictions 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.
−Removed: Many Privacy 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.
+Added: Many privacy laws and regulations 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 laws may result in, among other things, civil and criminal liability, negative publicity, damage to our reputation and liability under contractual provisions.
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We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our business.
−Removed: 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 other applications and technologies, particularly in our Technology & Analytics Solutions and Research & Development Solutions businesses.
−Removed: We are building artificial intelligence (AI) technologies into internal applications and solutions we use with others, including clients;
−Removed: we expect the use of AI to grow.
+Added: 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 other applications and technologies.
+Added: We are building AI technologies into internal applications and solutions we use with others, including clients;
+Added: we expect the use of AI to continue to grow.
+Added: The development, deployment, and commercialization of certain AI‑enabled offerings and services involve significant uncertainty, including risks that models may not perform as intended, may produce incomplete, misleading, or biased outputs, or may not be adopted by customers at the pace or scale we expect.
We seek to address some of our technology risks by increasing our reliance on the use of innovations by cross-industry technology leaders and adapt these for our biopharmaceutical and healthcare industry clients.
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Significant technological change could render certain of our services obsolete.
+Added: If our investments in AI‑enabled services and offerings do not keep pace with rapid innovation by competitors or technology providers, or if alternative AI solutions evolve more quickly or are more cost‑effective than our offerings, certain of our existing services or platforms could become less competitive or economically viable.
Moreover, the introduction of new services embodying new technologies could render certain of our existing services obsolete.
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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.
−Removed: Regulations relating to the use of AI and the interpretation of those regulations by regulators, courts and others are in the early stages of development and evolving, which may make it difficult to identify adequate compliance requirements or suitable governance practices to meet those requirements.
+Added: Regulations relating to the use of AI and the interpretation of those regulations by regulators, courts and others are in the early stages of development and evolving, which may make it difficult to identify or implement adequate compliance requirements or suitable governance practices to meet those requirements, including the activities described in Item 1.
+Added: Artificial Intelligence in this Annual Report on Form 10-K.
These types of failures could have a material adverse effect on our operating results, financial condition and reputation.
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We may be adversely affected by client or therapeutic concentration.
−Removed: Although we did not have any client that represented 10% or more of our revenues in 2024, 2023 and 2022, we derive the majority of our revenues from a number of large clients.
+Added: Although we did not have any client that represented 10% or more of our revenues in 2025, 2024 or 2023, we derive the majority of our revenues from a number of large clients.
If any large client decreases or terminates its relationship with us, our business, results of operations or financial condition could be materially adversely affected.
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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 the other countries, resulting in delays or potential cancellation of contracts, which in turn may result in loss of revenues;
−Removed: • the United States or foreign countries have and could continue to enact legislation or impose regulations or other restrictions, including unfavorable labor regulations, tax policies, trade barriers, 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 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;
+Added: • the United States or foreign countries have and could continue to enact legislation or impose regulations or other restrictions, including unfavorable labor regulations, tax policies, trade barriers, tariffs, 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 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 framework 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;
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• clients in foreign jurisdictions may have longer payment cycles, and it may be more difficult to collect receivables in foreign jurisdictions;
−Removed: • natural disasters, public health emergencies and pandemics such as the COVID-19, including any variants, or international conflict, such as the ongoing conflict between Russia and Ukraine, or terrorist acts, could interrupt our services, endanger our personnel, lower patient visits and increase patient drop-out rates, cause delays in recruitment of new patients, decrease the productivity of our clinical research associates, cause other project delays or loss of clinical trial materials or results.
+Added: • natural disasters, public health emergencies and pandemics, or international conflict, such as the ongoing conflict between Russia and Ukraine, or terrorist acts, could interrupt our services, endanger our personnel, lower patient visits and increase patient drop-out rates, cause delays in recruitment of new patients, decrease the productivity of our clinical research associates, cause other project delays or loss of clinical trial materials or results.
These risks and uncertainties could negatively impact our ability to, among other things, perform large, global projects for our clients.
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Any such risks could have an adverse impact on our financial condition and results of operations.
−Removed: Climate change may have an impact on our business.
−Removed: While we have determined that, at this time, climate change does not present a material risk to our business given the nature of our activities, we continue to evaluate and mitigate our business risks associated with climate change, and we recognize that there are inherent climate-related risks wherever business is conducted.
−Removed: Any of our office or IT systems locations may be vulnerable to the adverse effects of climate change.
−Removed: Furthermore, climate change may impact patients in our clinical trials and our employees, particularly where they work remotely.
+Added: Environmental events may have an impact on our business.
+Added: While we have determined that, at this time, environmental events do not present a material risk to our business given the nature of our activities, we continue to evaluate and mitigate our business risks associated with environmental events, and we recognize that there are inherent climate-related risks wherever business is conducted.
+Added: Any of our office or IT systems locations may be vulnerable to the adverse effects of environmental events.
+Added: Furthermore, environmental events may impact patients in our clinical trials and our employees, particularly where they work remotely.
Changing market dynamics, global policy developments, and the increasing frequency and impact of extreme weather events on critical infrastructure have the potential to disrupt our business, the business of our third-party suppliers, and the business of our customers, and may cause us to experience losses and additional costs to maintain or resume operations.
−Removed: Increasing focus on sustainability and other similar initiatives could increase our costs, and inaction could harm our reputation and adversely impact our financial results.
−Removed: There has been increasing public focus by investors, customers, environmental activists, the media, and governmental and nongovernmental organizations on a variety of environmental and sustainability matters.
−Removed: In light of the importance of this to our internal and external stakeholders, if we are not effective in addressing environmental and sustainability matters affecting our business, or setting and meeting relevant sustainability goals, our reputation and financial results may suffer.
−Removed: We may experience increased costs in order to execute upon our sustainability goals and measure achievement of those goals, which could have an adverse impact on our business and financial condition.
−Removed: In addition, this emphasis on environmental and sustainability matters has resulted and may result in the adoption of new laws and regulations, including new reporting requirements (including, but not limited to the EU Corporate Sustainability Reporting Directive, the EU Taxonomy, and the EU Corporate Sustainability Due Diligence Directive).
−Removed: Such rules may require us to incur significant additional costs to comply, including the implementation of significant additional internal controls processes and procedures regarding matters that have not been subject to such controls in the past, and impose increased oversight obligations on our management and Board.
−Removed: If we fail to comply with new laws, regulations, or reporting requirements, our reputation and business could be adversely impacted.
+Added: The expectations and requirements of regulators and other key stakeholders on sustainability-related matters, continue to evolve and diverge, and our ability to meet these expectations and requirements could increase our costs, and inaction could harm our reputation and adversely impact our financial results .
+Added: We are subject to rapidly changing and varied expectations and requirements on sustainability-related issues, from a wide range of stakeholders, such as governmental and self-regulatory organizations, including the Securities and Exchange Commission, U.S.
+Added: federal and state governments, New York Stock Exchange, and the European Union, as well as our investors, customers and suppliers.
+Added: In addition, many of our stakeholders have diverging demands, perspectives and preferences on a variety of sustainability topics.
+Added: We may not be able to meet the diverging expectations and demands of all of our stakeholders, which could result in an adverse impact on our business, financial results, stock price or reputation, and subject us to legal, reputational and operational risks.
+Added: For example, U.S.
+Added: federal, state and local governmental authorities, as well as governmental authorities in various jurisdictions, have proposed or implemented and are likely to continue to propose or implement, legislative and regulatory initiatives around corporate governance and environmental and social practices and disclosures.
+Added: Compliance with such evolving expectations, rules and regulations, including any that may emerge in the future as well as customer expectations and requirements, could increase the cost and complexity of operating our business, and could adversely impact us.
+Added: In addition, various jurisdictions have adopted or proposed laws, regulations and policies that diverge from, or potentially conflict with, those adopted or proposed in other jurisdictions, making compliance more difficult and uncertain.
+Added: Failure to comply with any law, regulation or policy, including as a result of making good faith interpretations that may differ from those taken by authorities in relevant jurisdictions, could potentially result in legal, reputational and operational risks.
In addition, compliance with new laws, regulations, and reporting requirements may increase our costs, result in disclosures of potentially competitively sensitive information, or may cause us to be targeted by activists, regulators, or others who want us to take a different approach to such matters or increase our disclosures or commitments.
+Added: Furthermore, any actual or perceived failure to achieve our current and future sustainability goals, including those which result from customer expectations or requirements, or to act responsibly with respect to such matters or to effectively respond to new or additional sustainability-related legal or regulatory requirements, could result in adverse publicity and adversely affect our business and reputation.
+Added: There is no assurance that we will be able to successfully achieve any sustainability-related goal or execute on any sustainability-related strategy, or adequately meet stakeholder expectations with respect to such matters.
In addition, certain environmental and sustainability disclosures and commitments we make may be reliant in part or in whole on third party information, which we cannot verify the quality of, and third party performance, which we cannot guarantee.
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Some of our services involve direct interaction with clinical trial subjects or volunteers and subcontracting into a network of Phase I clinical facilities, which could create potential liability that may adversely affect our results of operations, financial condition and reputation.
−Removed: We subcontract into a network of facilities where Phase I clinical trials are conducted, which ordinarily involve testing an investigational drug on a limited number of healthy individuals, typically 20 to 80 persons, to determine such drug’s basic safety.
+Added: We both own a facility and subcontract into a network of facilities where Phase I clinical trials are conducted, which ordinarily involve testing an investigational drug on a limited number of healthy individuals, typically 20 to 80 persons, to determine such drug’s basic safety.
Failure to operate such a facility in accordance with applicable regulations could result in that facility being shut down, which could disrupt our operations.
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This liability, particularly if it were to exceed the limits of any indemnification agreements and insurance coverage we may have, may adversely affect our financial condition, results of operations and reputation.
−Removed: Our Contract Sales & Medical Solutions business could result in liability to us if a drug causes harm to a patient.
+Added: Our Commercial Solutions business could result in liability to us if a drug causes harm to a patient.
While we are generally indemnified and insured against such risks, we may still suffer financial losses.
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There is significant and increasing competition for qualified personnel, particularly those with higher educational degrees, such as a medical degree, a Ph.D.
−Removed: or an equivalent degree, or relevant experience in the industry, including highly technical specialties such as clinical research associates, project managers and technology developers, and in the locations in which we operate.
+Added: or an equivalent degree, cutting-edge skillsets, such as AI and machine learning, or relevant experience in the industry, including highly technical specialties such as clinical research associates, project managers and technology developers, and in the locations in which we operate.
Increases in inflation, competition and shortages of qualified personnel in certain specialty areas may make it more difficult to hire and retain our key employees and could result in substantial increased costs, such as increased wage rates to attract and retain employees.
+Added: Our efforts to attract, develop and retain highly skilled employees may be compounded by intensified restrictions on immigration particularly if fees are increased significantly on the transfer, renewal or extension of work visas.
The departure of our key employees, or our inability to continue to identify, attract and retain qualified personnel or replace departed personnel in a timely fashion, may impact our ability to grow our business and compete effectively in our industry and may negatively affect our ability to meet financial and operational goals.
+Added: We continue to hire personnel in countries where exceptional technical knowledge and other expertise are offered at lower costs, which increases the efficiency of our global workforce structure and reduces our personnel-related expenditures.
+Added: Nonetheless, as globalization continues, competition for talent in those countries has increased, which may impact our ability to retain these employees and increase our compensation-related expenses.
Disruptions in the credit and capital markets and unfavorable general economic conditions could negatively affect our business, results of operations and financial condition.
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From time to time, we have adopted restructuring plans to improve our operating efficiency through various means such as reduction of overcapacity, elimination of non-billable support roles or other realignment of resources.
+Added: For example, starting in the first quarter of 2026, we have restructured our operations to reduce our reportable segments from three to two.
Restructuring presents significant potential risks of events occurring that could adversely affect us, including:
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Because of their size and focus, these companies might compete effectively against us, which could have a material adverse impact on our business.
−Removed: In addition, the emergence of the use of Real World Evidence and new approaches such as machine learning and artificial intelligence that capitalize on the availability of large data sets may reduce the time and costs of the discovery and development process, may allow our clients to more readily perform for themselves clinical development tasks and services that we have typically provided, may cause even greater price competition or may render certain data offerings less valuable or relevant.
+Added: In addition, the emergence of the use of Real World Evidence and the advancements in new approaches such as machine learning and artificial intelligence (AI), including generative, agentic and foundation models that are increasingly accessible through third‑party or open‑source platforms, that capitalize on the availability of large data sets may reduce the time and costs of the discovery and development process, may allow our clients to more readily perform for themselves clinical development tasks and services that we have typically provided, may cause even greater price competition and/or reduce the perceived differentiation of certain of our information, analytics and insight‑based offerings.
+Added: If customers are able to obtain comparable insights through alternative AI‑enabled solutions, develop such capabilities internally, or shift spending toward lower‑cost providers, demand for certain of our services and offerings could decline, pricing pressure could increase, and our margins and growth prospects could be adversely affected.
More broadly, our current competitors or other businesses might develop technologies or services that are more effective or commercially attractive than, or render obsolete, our current or future technologies and services.
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If regulatory cost containment efforts limit the profitability of new drugs by, for example, continuing to place downward pressure on pharmaceutical pricing and/or increasing regulatory burdens and operating costs of the biopharmaceutical industry, our clients may reduce their research and development spending or promotional, marketing and sales expenditures, which could reduce the business they outsource to us.
−Removed: For example, in August 2022, the Inflation Reduction Act was signed into law in the United States, which, among other things, requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
+Added: Any significant change in regulations, such as the Inflation Reduction Act of 2022 (IRA), which contains drug price negotiation provisions, or change in the interpretation of existing regulations, could reduce demand for our offerings or increase our expenses.
+Added: For example, in May 2025, the Trump administration issued an executive order entitled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” which, among other things, directs the HHS and other agencies to communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for U.S.
+Added: patients in line with comparably developed nations and to facilitate direct-to-consumer purchasing programs.
+Added: It is currently unclear whether and to what extent these measures will be implemented and what impact any such implementation would have on our business.
In addition, changes to the Medicaid program or the federal 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities, could have a material impact on our customers, which could reduce demand for our services.
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Interest rate fluctuations and our ability to deduct interest expense may affect our results of operations and financial condition.
−Removed: In 2024, financial regulators in various jurisdictions, including where we have variable-rate indebtedness outstanding, cut interest rates modestly while signaling that interest rates could remain higher compared to recent years for an extended period of time in an effort to lower inflation.
+Added: In 2025, financial regulators in various jurisdictions, including where we have variable-rate indebtedness outstanding, cut interest rates modestly while signaling that interest rates could remain higher compared to the pre-2022 period for an extended period of time in an effort to lower inflation.
Because we have variable rate debt, increases in interest rates will lead to increases in our borrowing costs and may adversely affect our results of operations and financial condition.
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Our certificate of incorporation and Delaware bylaws and the General Corporation Law of Delaware (the “DGCL”) contain provisions that could make it difficult for a third party to acquire IQVIA even if doing so might be beneficial to its stockholders, including:
−Removed: • the division of the board of directors into three classes (subject to gradual declassification which began at the 2023 annual meeting of stockholders, such that our board of directors will be fully declassified and each director will be elected to a one-year term beginning at the 2025 annual meeting of stockholders);
• the sole ability of the board of directors to fill a vacancy created by the death or resignation of a director or the expansion of the board of directors;
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• introduction of new services by us or our competitors;
+Added: • changes in investor perception regarding the role, effectiveness, risks or regulatory implications of artificial intelligence in our business or in the healthcare and life sciences industries more broadly;
+Added: • concerns, whether or not substantiated, regarding the accuracy, reliability, ethical use, governance, or regulatory compliance of AI-enabled solutions;
• issuance of new or changed securities analysts’ reports or recommendations;
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.