What IQVIA Holdings Inc. told the SEC could break it.

IQVIA's involvement in testing new drugs on patients in clinical trials (and drugs reaching market) creates liability risk for personal injury to or death of patients — particularly those with life-threatening illnesses — from adverse reactions.

“Our involvement in the clinical trials and development process creates a risk of liability for personal injury to or death of patients, particularly those with life-threatening illnesses, resulting from adverse reactions to the drugs administered during testing or after product launch, respectively.”

Advancements in ML/AI (including generative, agentic, and foundation models accessible via third-party/open-source platforms) and Real World Evidence may let IQVIA's clients perform clinical-development and analytics tasks themselves, intensifying price competition and eroding the differentiation of its offerings.

“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.”

IQVIA's CRO (Research & Development Solutions) business must conduct clinical trials under Good Clinical Practice and FDA/EMA/MHLW requirements; non-compliance with GCP/data-integrity rules could jeopardize study results and bring regulatory sanctions.

“The United States Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”), Japan's Ministry of Health, Labor and Welfare and most other global regulatory authorities expect that study results and data submitted to such authorities be based on clinical trials conducted in accordance with GCP provisions.”

IQVIA's information/analytics business depends on third parties for data and support services; suppliers could restrict use, refuse to license data, or stop providing services, leaving IQVIA unable to access certain data or deliver certain offerings.

“We depend on third parties for data and support services. Our suppliers or providers might restrict our use of or refuse to license data or provide services, which could lead to our inability to access certain data or provide certain services and, as a result, materially and adversely affect our operating results and financial condition.”

About 30% of IQVIA's 2025 revenue was denominated in non-USD currencies (~60 currencies), and many R&D contracts are USD/Euro while costs to fulfill them are in local currencies — exposing results to exchange-rate fluctuations.

“In 2025, approximately 30% of our revenues were denominated in currencies other than the United States dollar, which represents approximately 60 currencies. Because a large portion of our revenues and expenses are denominated in foreign currencies and our financial statements are reported in United States dollars, changes in foreign currency exchange rates can significantly affect our results of operations.”