The World Health Organization estimates that there are 2 million different kinds of medical devices worldwide. Recent research indicates that the medical devices market is projected to reach US$964.9 billion by 2030, fuelled by growth in the incidence of chronic diseases and the number of technical innovations that improve quality of life. In turn, there is a growing demand for medical device clinical trials. To support developers who face constraints in conducting clinical trials in-house, medical device contract research organizations (CROs) take on the role of clinical operations and regulatory affairs. To further expand their capabilities, medical device CROs integrate tech and tools, including cloud computing, risk monitoring tools, real-world evidence, and advanced data analytics. The medical device CRO market is projected to grow at a compound annual growth rate (CAGR) of 9.6% to exceed US$15.1 billion by 2030.
A CRO’s Purpose
A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO’s purpose is to provide expertise and resources that allow these industries to outsource their clinical trials, regulatory affairs, and other research-related functions. By doing so, CROs help these industries bring their products to market faster and more efficiently, while maintaining high standards of quality and compliance.
CROs also offer a range of services, such as study management, data management, statistical analysis, and regulatory consulting. These services allow CROs’ clients to focus on their core business activities, while CROs handle the often complex and time-consuming aspects of clinical research. CROs possess a unique combination of scientific, regulatory, and operational expertise, which they bring to bear on behalf of their clients. Their goal is to help their clients achieve their research objectives quickly and efficiently while ensuring that the highest ethical and scientific standards are maintained throughout the research process.
Below, we list the top ten CROs for medical device clinical trials.
CRO 1: Avania
Avania, formerly known as Factory CRO which was founded in 1988, came into being in 2020 as a leading platform in MedTech outsourcing. Avania is an integrated global, full-service CRO specializing in medical devices, novel technology, and combination products. The Medical Device CRO supports products from feasibility to post-approval in analytics, clinical trials, consulting, regulatory, and reimbursement. It has experience across all medical device classifications. Avania has supported over 800 medical device and diagnostic projects, over 350 medical device and diagnostic clinical trials, over 350 regulatory submissions, and over 20 breakthrough designations.
CRO 2: CMIC Holdings Co., Ltd.
CMIC celebrates its 30th anniversary as the first company to offer CRO services in Japan. The CMIC Group Network now comprises 26 companies with 62 sites in Asia, Australia, and the US, supported by 7,735 employees. For medical devices and in vitro diagnostics (IVDs), CMIC provides combination services for products in two domains, e.g., drug-eluting stents, which fall into the drug and medical device categories. CMIC has the experience and expertise in consulting on regulatory issues for medical devices, especially high-risk and state-of-the-art products. These include SaMDs (software as a medical device). Medical device services include registration, business license, exporting outside of Japan, and exporting to Japan.
CRO 3: CTI
CTI started as a small team in transplantation in 1999 and has grown consistently to become a global organization with associates in more than 60 countries. CTI specializes in chronically and critically ill patients and has now worked on more than 10,000 projects and contributed to more than 150 new drug and device approvals through global regulatory agencies. CTI works with over 250 pharma, emerging biotech, and medical device companies. CTI has experience in device and IVD development across multiple therapeutic areas and programs with drug/device combinations or cell and gene therapy/device products. The CTI team provides regulatory strategy consulting, clinical trial design and execution, and Clinical Evaluation Report (CER) development.
CRO 4: Eurofins
Eurofins Scientific is a group of international life sciences companies that provide analytical testing services across multiple industries. It is a global independent market leader in genomics, in support of clinical studies, and in biopharma contract development and manufacturing. The Eurofins network of over 1,000 independent companies operates in 59 countries and is supported by more than 61,000 workers. Eurofins has 30 years of experience testing medical devices and eight research centers providing full CRO services with in-house medical experts dedicated to medical devices. Eurofins supports pre- and post-market clinical investigations, and sponsors have access to in-house clinical trial facilities with expertise in medical device investigations.
CRO 5: Labcorp
Laboratory Corporation of America Holdings (LabCorp), founded in 1969, is a global life science and healthcare company with diagnostics and drug development capabilities. Labcorp has over 75,000 employees operating in more than 100 countries. Labcorp has 150 device development specialists for medical device and diagnostic development and offers sponsors support throughout the development journey, from preclinical testing to regulatory approvals, market launch, and post-market studies. In the past five years, the Labcorp team has supported 500 device trials.
CRO 6: Medelis
Founded in 2003 as a full-service oncology CRO, Medelis offers a partner-like approach with dedicated trial project managers. The Medelis Medical Device and Diagnostics CRO has expertise in navigating strategy pathways, classifications, and registration requirements. With its experience in clinical program execution, product development, expansive site relationships, and knowledge of processes and systems, Medelis is well-positioned to manage the unique demands of medical device and diagnostics clinical trials and submissions. The team has covered Class I to III devices, including drug delivery and drug-device combination products, companion diagnostics and IVDs, medical devices and software, surgical tools and systems, over-the-counter (OTC) products, and consumer products.
CRO 7: NAMSA
NAMSA is a MedTech CRO that provides the entire continuum of development solutions, including regulatory, reimbursement, quality consulting, and clinical research services, to clients in all major global markets. NAMSA has 1,500 international associates operating in 18 locations worldwide. Every year, NAMSA has 2,000 medical devices and diagnostic client partnerships, whereby 90% of clients recommend NAMSA. Since its inception in 1967, it has assisted thousands of MedTech sponsors and supported 10,000 devices in gaining approval. In the last few years, NAMSA has played a role in developing domestic and international standards for testing medical devices, materials, and IVDs.
CRO 8: Parexel
Parexel is a global CRO that supports the development of innovative interventions through its clinical development capabilities and integrated consulting expertise. It has more than 19,000 international professionals around the world. The Parexel Medical Devices CRO regulatory consultants, some former regulators, are well-equipped to work on regulatory strategies, manage meetings with regulatory bodies, and assist with device exemptions. Compliance experts support sponsors at all stages of development to meet US Food and Drug Administration (FDA), European Union (EU), and ISO 13485 requirements.
CRO 9: ProTrials
ProTrials is a woman-owned full-service CRO that works with the medical device, diagnostics, pharma, and biotech industries. Founded in 1996, ProTrials is based in the US, with clinical operations worldwide. Recognizing that the clinical trial and approval process for devices and diagnostics differ from that for drug development, the ProTrials Medical Device and Diagnostics CRO has a device team with the experience and expertise to navigate the terrain. The device team understands the regulatory requirements, operational guidelines, and safety considerations well. In addition, more than half of all ProTrials staff have medical device experience. More than 35 medical device and diagnostics projects have been conducted across over 20 indications.
CRO 10: Qserve Group
Qserve has its beginnings as a group of regulatory experts coming together in the Netherlands and is now a global medical device consulting group about to celebrate its 25th anniversary. Since 1998, Qserve has grown and expanded its services and footprint, establishing a presence in the US, China, Germany, and the UK. It provides support in regulatory compliance, clinical trials, quality assurance, and training to enable registration, approval, and market access of medical devices in global markets. Qserve Medical Device CRO services began in 2016. Its expertise includes feasibility, pre-CE, and post-market studies for Class I to Class III medical devices. Qserve has experience in multiple indications, including urology, neurology, dental, cardiovascular, orthopedics, and ophthalmology.
The Vial CRO
Vial is a global, full-service CRO building towards a more efficient future for clinical trials. As a tech-powered medical device CRO, our innovative approach merges cutting-edge technology with clinical expertise to reshape the landscape of medical device research. With a commitment to efficiency and excellence, we harness the power of our advanced platforms, TrialOS, to seamlessly integrate Electronic Data Capture (EDC), eSource, ePRO, eTMF, and more into one cohesive system.
This tech-driven foundation enables us to accelerate the development of medical device solutions while ensuring precision and regulatory compliance. By deploying technology in every step of a trial, we are driving efficiencies in speed and cost that we pass on to innovative biotech startups.
Connect with our team to dive deeper into what sets the Vial CRO apart from the rest.
