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"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

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Harness the power to transform clinical development

Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.

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Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.

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THE IQVIA INSTITUTE

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.

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"Global Trends in R&D 2024

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"IQVIA thought leadership with a focus on EMEA.

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"DCTs Deliver Big ROI

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"Capturing value at scale: The $4 billion RWE imperative

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Unlock your potential to drive healthcare forward

By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.

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IQVIA AI is Healthcare-grade AI

Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.

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Your healthcare data deserves more than just a cloud.

The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

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Innovations make an impact when bold ideas meet powerful partnerships

The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.

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Proven, faster DCT solutions

IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.

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IQVIA Patient Experience Solutions powered by Apple

Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. IQVIA and Apple are collaborating to bring this exciting future of personalized care directly to devices patients already have and use.

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WHITE PAPER
Regulations and Reimbursement of Software as a Medical Device in Europe- Part1
Jan 13, 2023
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Over the past decades, the development in software used alone or together with a medical device has significantly increased. This is due to the increased adoption of smart technology such as smartphones, wireless connectivity, cheaper and better sensors, cloud computing, big data and Artificial Intelligence (AI) which are alerting healthcare delivery across the world. With the advancement of these technologies leading to a shift in how healthcare is administered and delivered, software has become an essential component of the development of medical devices. Particularly "Stand alone" software or "Software as a Medical Device (SaMD)" has seen fast growth recently as there is no hardware involved, fewer constraints as well as the use of fast feedback loops for improvement.

In Part 1 of this publication series, we explore SaMD definition, it's challenges and the ways the regulatory bodies try to address them, as well as the expected development of regulations related to Artificial Intelligence (AI) and Machine Learning (ML) in SaMD.

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