Outsourcing Clinical Trials for Medical Device Companies
White Paper
Dec 11, 2019

Whether your organization is a large manufacturer or a small new venture, clinical trial outsourcing is a complex process. A successful procurement can be managed with good planning and careful selection of the right partner.

  • Will the CRO build positive relationships with my investigators?
  • Are the monitors therapeutically aligned?
  • Can the CRO effectively work with my field engineering and clinical staff?
  • Is the cost-value of partnering the choice for my business?

Based on over 20 years of experience leading more than 200 medical device and in vitro diagnostics trials across the globe, this paper guides you through a successful contract research organization (CRO) outsourcing process and helps you select the best CRO partner.

This paper addresses best practices for medical device and diagnostics clinical trials outsourcing, based on over 20 years of experience leading more than 200 medical device and in vitro diagnostics trials across the globe. IQVIA MedTech considers finding a provider that is aligned not just therapeutically, but also with your technology and culture, to be critical in a successful partnership. Our dedicated device trials team is aligned to your therapy, your technology, and your team.

As a medical device manufacturer, you and your business leaders are looking for smarter ways to get trials done more efficiently and on budget. Trusting a CRO with your trial can drive results, but also raise risks – will the CRO build positive relationships with my investigators? Are the monitors therapeutically aligned? Can the CRO effectively work with my field engineering and clinical staff? And perhaps most importantly, is the cost-value of partnering the choice for my business? This paper is geared to answer these important questions and help you select the best CRO partner.


CROs and device sponsors go global

Modern medical device and diagnostics sponsors and CROs are increasingly global. In 2019 there are more than 3,000 contract research organizations (CROs) operating worldwide with total combined market revenues exceeding $21 billion, operating 83% of trials in high-income countries. A decade ago, the top 5 CROs employed fewer than 30,000 people, and now there are over 100,000 employees worldwide.

Globalization adds a new aspect to clinical trial outsourcing, with more than 80% of manufacturers executing trials in more than one country, compared to less than half that a decade ago. While the United States remains the largest market for medical devices, in part due to the friendly regulatory environment for novel MedTech ventures, Asia-Pacific (APAC) is growing by more than 20% each year – making it one of the fastest growing markets in the world.

Selected in 2019 as one of FORTUNE’s “World’s Most Admired Companies®,” IQVIA has feet on the ground in more than 100 countries. This enables us to ensure your medical device trials are executed compliantly and effectively, no matter where in the world your technology is heading.


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