- Why Us
In the rapidly evolving MedTech industry, companies encounter numerous challenges while striving to bring devices to market. Among these, conducting effective clinical trials stands out as a critical step, ensuring both compliance and go-to-market success. This means establishing a plan, selecting sites, collecting high-quality clinical data, meeting milestones, conducting analysis, and executing projects in compliance with regulations.
Developing a new medical device intended to improve the quality of lives requires the highest quality processes possible. For clinical studies, this means the resources involved in planning and executing these projects must be qualified and capable of achieving this outcome.
For many MedTech companies, a contract research organization (CRO) is an essential partner in this process, offering industry expertise, project management, risk mitigation, and trial conduct oversight.
At Greenlight Guru, we recognize how important it is to select the right CRO for your business. That’s why we partner with top CROs across the globe. Our Clinical Electronic Data Capture (EDC) solution is a key ingredient to the overall clinical trial process. It provides a comprehensive package specifically designed for the unique requirements of medical device clinical trials. If you’re a CRO interested in partnering with Greenlight Guru, learn more here.
If you’re a MedTech company looking to simplify your search for the right CRO, we’ve compiled a detailed list below. This list, while not a ranking, is a compilation of providers that highlights each of their strengths and core services to aid in your search.
Location: Marlborough, MA
Avania brings knowledgeable experts together to form a unique CRO that advances the research of medical devices, novel technology, and combination products across a wide range of therapeutic specialties. Their motivated team takes you from feasibility all the way through post-market trials. Avania’s experts in data management and analytics, clinical trial design & execution, strategic consulting, regulatory, reimbursement, and more will provide you with customized, scalable solutions that optimize efficiencies and streamline the advancement of your medical technology.
Location: Washington, DC
MCRA is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client’s industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly clients globally.
Location: Morrisville, North Carolina
Premier Research, the clinical research company that’s Built for Biotech, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. More than just clinical services, they offer unique perspectives, intelligent study designs, and relentless focus on compliance and providing conclusive data. Ongoing investments into innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Location: Durham, North Carolina
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Location: Durham, North Carolina
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients.
Location: Atlanta, Georgia
NAMSA proudly serves the MedTech industry’s premier CRO partner for cost-efficient and efficacious outcomes that lead to accelerated development and marketplace success. NAMSA provides unparalleled medical device testing capabilities, strategic guidance, and tactical support to fast-track market introduction. They are committed to helping clients overcome development hurdles, mitigate concerns, and streamline commercialization efforts.
Location: Helsinki, Finland
Clinical device trial and Medical Regulations specialist Clinius is a device CRO with main focus on clinical trials and regulatory consulting. We support companies in the healthcare and well-being industry in understanding the needs of customers as well as meeting the regulatory requirements (MDR/IVDR). We have more than 20 years experience with supporting device development. Our key services- MDD to MDR transition - Documentation for Medical CE-marking - ISO 13485 quality management systems - Pre-audits - Clinical device trials - Clinical evaluations - Training
Location: Agno, Switzerland
1MED, is the leading European MedTech specialized solutions provider, offering end-to-end development expertise within the medical device, novel technology and combination products fields. Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED's mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR.
Such support may include providing preclinical support, regulatory advice, clinical study management, post-marketing support and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices in the last 2 years
Location: Biel/Bienne, Switzerland
ISS AG, Integrated Scientific Services provides services to medtech companies for the development of medical devices, their introduction into the market and their maintenance. Typical services include medical software development, regulatory affairs and clinical evaluation report writing, clinical research, quality management, qualification and validation. The combination of these services with scientific work methods and project management puts ISS AG into a unique position as a service provider for the medtech industry.
Location: Arnhem, The Netherlands
Qserve CRO is dedicated to driving the advancement of medical technologies and therapies through meticulous and impactful clinical investigations. As a leading Contract Research Organization, they specialize in providing comprehensive services that support the successful design, development, execution, and management of clinical trials. Their team of seasoned experts brings together a wealth of knowledge and experience, ensuring that your clinical trials are conducted with precision, compliance, and a commitment to delivering results that make a difference.
Location: Raleigh, North Carolina
Veranex offers best-in-class clinical and regulatory expertise, helping move your MedTech innovation to market. Veranex can help if you are in the process of moving your device to the market, looking to expand your claims, or working to comply with emerging post-market data collection requirements. Veranex’s in-depth regulatory expertise and clinical trial execution capabilities will ensure you’re checking the right boxes.
Location: Copenhagen; Denmark
Evnia provides the Medical Device, Pharma and Biotech industries with specialised consulting services in the areas of Regulatory Affairs/Compliance, R&D, and Management by transforming data and regulations into measurable actions and tailored solutions.
They promote patient care and quality of life by striving, seeking, and finding solutions that support compliance and R&D decisions in investments, innovation and medical/regulatory communications.
Location: Houston, Texas
Proxima CRO works with emerging biotech and medical device companies across all phases of development. As a contract research organization, Proxima organizes their team in two distinct areas: early-stage advisory consulting and all-inclusive clinical trial services.
Proxima CRO helps innovative companies overcome regulatory and clinical obstacles to get their medical products approved.
Location: Liestal, Switzerland
HEMEX is a global provider of clinical research services to small and medium-sized life sciences companies in diverse therapeutic areas. By combining extensive clinical expertise, commitment to speed, and dedication to patient-centric approaches, HEMEX supports its clients to complete their clinical trials faster. Advancing healthcare and improving patient outcomes, HEMEX’s priority is ensuring patients can have access to lifesaving therapies within a short clinical journey. Through its subsidiaries, Hemex Germany GmbH and Hemex Benelux BV, the company can also secure project funding through different EU funds.
Location: Copenhagen, Denmark
Qmed is a full service Clinical Research Organisation(CRO) specializing in medical devices managing clinical trials and conducting strategic consultancy within regulatory affairs, quality assurance market access and reimbursement. Qmed provides strategic consulting services in connection with medical device approval as well as best-in-class expertise within clinical trial management, regulatory affairs, quality management and reimbursement and market access.
Location: Great Britain, United Kingdom
Clinical Accelerator is a full-service clinical CRO and a patient enrolment organization, with particular expertise in Central & Eastern Europe where they have thorough experience in all services relevant to clinical trials and research. In collaboration with their dedicated partners, they also operate in other countries of the world and are happy to discuss global requirements.
Location: Düdingen, Switzerland
Confinis is a global consulting firm in the field of medical devices, in vitro diagnostics and combination products based in Switzerland and the USA. Confinis services include regulatory affairs, quality management, design control, risk management, usability engineering/human factors, clinical evaluation, labeling, manufacturing, process validation, supply chain, post-market monitoring, auditing, and training. Their experienced and highly motivated team consists of electrical, mechanical, software, and biomedical engineers, as well as physicists, pharmacists, medical doctors, chemists, biochemists, biologists, and biotechnologists.
Location: Orlando, Florida
bioaccess™ is a US-based CRO that bridges the gap between innovative Medtech companies and the untapped potential of conducting clinical research studies in Latin America. They are experts in delivering cost-effective and high-quality CRO services in Latin America. Bioaccess focuses on forward-looking Medtech companies seeking accelerated pilot, first-in-human (FIH), early-feasibility (EFS), pivotal, or post-market clinical study results.
Location: Cambridge, Massachusetts
SerenaGroup® Research (SGR), under the direction of Thomas Serena MD FACS, conducts clinical trials in a range of diseases related to wound healing, surgical site infections and diagnostics. SGR has set the standard in clinical trial design for chronic wounds, such as diabetic foot ulcers. To promote clinical research in the burgeoning field of wound care, SerenaGroup® established a site management organization (SMO) that assists hospitals and clinics in establishing compliant research programs. SGR has conducted more than 100 clinical trials at all phases.
Location: Tubingen, Germany
Novineon CRO GmbH is a consulting and research company in the field of healthcare technology. As a professional service provider, they support international manufacturers of medical devices and in-vitro diagnostics. In close relationships with their clients, they actively manage all aspects of preclinical and clinical research, clinical evaluation, PMS (post-market surveillance) and PMCF (post-market clinical follow-up) strategies as well as performance evaluation. Furthermore, they offer regulatory services in conformity assessment procedures, also in non-European markets.
Location: Basking Ridge, New Jersey
Hopkins MedTech Compliance is a CRO dedicated for IVD Clinical Performance Studies for FDA & EU and regulatory filing. The organization helps medical device companies rapidly access the industry's best consultants, contractors, and candidates. Their resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.
Location: Boulogne-Billancourt, France
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by compassion, care, and excellence. Founded in 2014 and headquartered in Paris, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with specialty focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
Location: Gardanne, France
Centaur Clinical is a CRO that runs clinical operations for Medical devices from pre-clinical trials to post-market up in Europe. The organisation runs your clinical studies with full respect of the regulatory framework for CE marking. Centaur Clinical has also set up partnerships all across the globe to provide the sponsor with an extensive service.
Location: Romainville, France
Oroxcell is an independent research organization (CRO) offering research services assessing the safety, toxicity and efficacy of active ingredients and finished formulations. Specialized in in-vitro testing, particularly in 3D Human Models, Oroxcell is developing its business on two fronts: safety & efficacy testing.
Location: Beverly, Massachusetts
For more than 30 years MDC has helped innovators and entrepreneurs bring In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. MDC’s mission is to continue to support diagnostic makers and innovators by applying our expertise in Regulatory and Clinical Affairs, Quality Systems, and Data Management to help launch new advances that promote and protect the health of our global and local communities.
Location: Toronto, Canada
Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. They serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting client needs.
Location: Wexford, Pennsylvania
Clinical Research Strategies assists new life sciences companies and healthcare IT entrepreneurs with their corporate start-ups. They distill the complexities of regulatory and research disciplines into accessible terms for life science executives, entrepreneurs, and investors alike who play a pivotal role in the development and investment of a new product. Clinical Research Strategies' goal is to improve your chances of clearing performance hurdles toward successful commercialization or exit.
Location: Heidelberg, Germany
Mediri works to make your image-based clinical trials more efficient, quick and safe. This is especially important when it comes to multicentre studies that place high demands on clinical data management.
Mediri provides the reinforcement you need with interdisciplinary services all from one single source. Their capability spans from imaging protocol and central data management to image data analysis with a clear evaluation of results. Mediri’s success is through the ability to put tremendous importance on creating shorter communication channels and providing highly qualified support for customers.
Location: Neuss, Germany
Profil GmbH is a full service CRO based in Germany and certified according to ISO 9001 and 13485. Profil was founded as a spin-off of an academic study group at the Department of Metabolic Diseases and Nutrition at the University of Dusseldorf. Unlike other CROs, they focus their clinical research on diabetes and related diseases.
Location: Grafelfing, Germany
Requalite provides regulatory, quality, and clinical study services for in vitro diagnostic and medical device compliance in the EU. Requalite is located in the heart of Europe, in Munich-Germany. They provide full CRO services for clinical studies as per IVDR/MDR. In addition, they provide Technical and medical writing services to manufacturers of Medical Devices and In-vitro Diagnostic devices to obtain CE-marking as per EU regulations of MDR (2017/745) and IVDR (2017/746) for entering the European market.
Location: Needham, Massachusetts
AlvaMed is a medical device consulting and outsourcing organization. They provide the full breadth of compliance services to their clients: quality assurance, quality system development, regulatory approval and compliance, and CRO/clinical management services. AlvaMed is an industry leader in medical device consulting and is comprised of technically savvy quality, clinical, and regulatory professionals with a broad range of complementary skills. The flexibility within their team allows them to quickly adapt their level of support to your changing needs or shift focus as you hire your own internal resources.
Location: Fort Washington, Pennsylvania
ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. We do this by combining our 25 years of proven quality and results with expertise in 30+ therapeutic areas, a flexible approach, and dedicated teams who enable rapid startups and fast timelines.
Location: Diepenbeek, Belgium
Archer Research is a full-service Contract Research Organization specializing in clinical studies with Medical Devices, located in the heart of Europe with a fast connection between Belgium, France, The Netherlands, The UK and Germany. They are experts in setting up and managing pre-CE as well as post-market medical device clinical studies from A to Z. Whether you are an investigator, an early-stage start-up, or a large organization, Archer Research can help you achieve your strategic goals through sound clinical and regulatory planning and execution.
Location: New York, New York
Meditrial is a leading provider of clinical trial services and digital cloud-based data management solutions for the medical device industry. As a Clinical Research Organization (CRO), Meditrial is renowned as the go-to partner for companies developing breakthrough devices that require a clearly defined path to first-in-man and pivotal clinical studies. Established in 2008, today Meditrial is a trusted European representative for large corporations as well as start-ups requiring support and resources to execute trials in Europe.
Location: Marly, Switzerland
AGINKO Research is the premiere CRO for preclinical work in osteoarticular pathologies. They offer a wide range of contract research services to support Drug and established Medical Device companies as well as start-ups and academia. From industry-standard protocols to customized research design, their animal models and assays, both on an in vivo or in vitro basis, provide key tools for compound discovery and product development. Given their expertise, know-how, and network in the field of osteoarticular pathologies, AGINKO today also offers a full range of histology services for your preclinical and clinical trials as well as general consulting services (e.g, regulatory, strategy, financing) devoted to osteoarticular pathologies.
Location: Roswell, Georgia
From protocol inception to trial execution and site management, all the way through to regulatory submissions, ClinTrialSolutions can help you with your clinical trial needs. With more than 30 years of experience in all aspects of clinical trials, including Investigator Initiated Trials (ISS) and Patient Reported Outcomes (PRO) Trials, ClinTrial Solutions is here to help you meet your clinical trial objectives on time and within budget.
Location: Berlin, Germany
OSMUNDA Medical Device Service Group, established in 2004, is a third-party service provider for medical devices and in-vitro diagnostic (IVDs), offering the medical device industry with global registrations, regulatory support, clinical trials (CRO), contract manufacturing (CDMO), as well as platforms for medical device management cloud (MDAC), medical-engineering cooperation & incubation, and industrial investment services. OSMUNDA Group has 12 wholly-owned branches with nearly 300 medical device experts worldwide (China, Germany, US, etc).
Location: Winterthur, Switzerland
Appletree CI Group is an expert niche CRO and global regulatory affairs service provider with track records in ophthalmology and medical device investigations. They are present in 11 European countries and have over 30 employees. By having an in-depth understanding of local cultures and customs, as well as experience with national regulations, they are able to facilitate your clinical development and regulatory projects.
Location: Los Angeles, California
MedQIA is a full-service global contract research organization specializing in Quantitative Image Analysis for clinical trials. It is their mission to deliver high-quality, innovative, computer-aided image interpretation and analysis for both clinical trials and radiological decision support. Biomarker Science MedQIA is a leader in bringing imaging biomarker science to clinical trials. The biomarker R&D program is a multidisciplinary, collaborative effort encompassing imaging physics, computer vision, pattern classification, biostatistics, and radiological sciences. Medqioa specializes in delivering cutting-edge quantitative imaging biomarkers in Phase I through IV studies for drugs and in medical devices.
Location: Bremen, Germany
AICROS, the Association of International CROs, is an official operative network of small to midsize CROs which provide clinical research services for the medical device, pharmaceutical, and biotech industries. They understand the challenges sponsors can face in every step of their clinical development process. They overcome these constraints by quickly adapting to changing environments, adhering to specific client requirements, and applying proactive problem-solving approaches throughout the whole project. AICROS combines the advantages of large and small to midsize CROs, while offering the reliability of a global CRO.
Location: Nanterre, France
Axonal-Biostatem is a full-service European CRO specializing in Real World Evidence, providing solutions and expertise in conducting post-approval studies with high knowledge of regulatory particularities across Europe. Axonal-Biostatem provides project support to pharmaceutical, biotech companies and medical device manufacturers in the management of Phase II to IV clinical trials, pharmacoepidemiological studies, surveys, and observational studies. Throughout the years, Axonal-Biostatem has acquired an elite team of experienced scientists capable of conducting international studies and delivering accurate results on time.
While our list of top 40 CROs that service medical devices ends here – the possibilities for you and your device are just beginning. We hope this list of the top contract research organizations will help you choose a partner to develop a safe and reliable medical device that achieves regulatory compliance, surpasses your company goals, and ultimately improves the lives of the patients who use it.
When companies combine the expert services of a Contract Research Organizations (CROs) with Greenlight Guru Clinical, the leading Electronic Data Capture (EDC) platform purpose-built for MedTech, it’s a winning combination for enabling product to market.
So if you’re looking for a partner who will be with you every step of the way, then get your free demo of Greenlight Guru Clinical and learn how we can help you make the switch from your old EDC or paper to a purpose-built solution as smooth and efficient as possible.
Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.