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Risk Factors (continued)
Risks related to the general economic and financial market conditions and the industries in which we operate
1.
The effects of the COVID-19 pandemic could adversely affect our business, results of operations, and financial condition.
2.
We depend entirely on the clinical trial market, and a downturn in this market could cause our revenues to decrease.
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Risks related to technology and intellectual property
2.
1. 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.
A failure or breach of our IT systems or technology could result in sensitive client information being compromised or otherwise significantly disrupt our business operations, which would negatively materially affect our reputation and/or results of
operations.
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Consolidation among our clients could cause us to lose clients, decrease the market for our products and result in a reduction of our revenues.
Our estimate of the market size for our services may prove to be inaccurate, and even if the market size is accurate, we cannot assure you that our business will serve a significant portion of the market.
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Computer malware, viruses, ransomware, hacking, phishing attacks and other network disruptions could result in security and privacy breaches and interruption in service, which would harm our business.
Our services are subject to evolving industry standards and rapid technological changes. If we do not keep pace with rapid technological changes, our services may become less competitive or obsolete, which could have a material adverse effect on our
business, results of operations and financial condition.
We rely on third parties to provide certain data and other information to us. Our suppliers or providers might increase our cost to obtain, restrict our use of, or refuse to license data, 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.
Risks related to political, legal and regulatory environment
1.
We may face political, legal and compliance, operational, regulatory, economic and other risks associated with the international expansion of our operations that we do not currently face or that are more significant than in our domestic operations.
Due to the global nature of our business, we may be exposed to liabilities under anti-corruption laws, including the United States Foreign Corrupt Practices Act, the United Kingdom Bribery Act and various international anti-corruption laws, and any
allegation or determination that we violated these laws could have a material adverse effect on our business.
2.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
If we fail to comply with certain healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, results of operations, financial condition, and prospects could be adversely affected.
Extensive governmental regulation of the clinical trial process and our products and services could require significant compliance costs and have a material adverse effect on the demand for our solutions.
We rely on third parties for important products, services and licenses to certain technology and intellectual property rights and we might not be able to continue to obtain such products, services and licenses.
We have only a limited ability to protect our intellectual property rights, both domestically and internationally, and these rights are important to our success.
Our cloud-based solutions and services utilize open source software, and any failure to comply with the terms of one or more of these open source licenses could adversely affect our business.
Data protection laws and regulations may limit the use of our platform and give rise to operational interruption, liabilities, and reputational harm, which could have a materially adverse impact on our business.
The enactment of legislation implementing changes in the U.S. taxation of international business activities, the adoption of other tax reform policies or changes in tax legislation or policies in jurisdictions outside of the United States could materially impact
our results of operations and financial condition.
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