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Medical Device & Diagnostics CRO

A global partner for medical device and diagnostic clinical studies

A global partner for medical device and diagnostic clinical studies

Streamline Your Path to Success

Ensure efficient timelines and budgets in medical device and diagnostic studies by partnering with a global medical device clinical research organization (CRO) that fully understands how to navigate and accelerate clinical research. Our dedicated medical device team of specialized medical, regulatory and operational experts work collaboratively with your team to design and conduct clinical research trials around the world.   

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A Full-Service Approach to Medical Device & Diagnostics Clinical Trials

Benefit from working with our experienced teams, who have the understanding of the potential challenges and obstacles presented in your clinical trial from pre-market through post-approval to post-market. Medpace brings a holistic and integrated approach to clinical research through a unique advantage: a dedicated medical device division combined with the global Medpace CRO.

A Global Partner for Medical Device Clinical Studies

With dedicated device teams in the U.S. and Europe, Medpace Medical Device has the global scope to provide a comprehensive array of services to support the unique needs of your trial. Our specialized model provides therapeutic and scientific leadership throughout your program’s lifecycle. Your program will benefit from:

  • Geographically diverse and multilingual employees who understand the local cultural environment for clinical research and your regulatory pathway, ensuring your program is interpreted and implemented efficiently and appropriately
  • Established relationships with clinical research sites, key opinion leaders, and therapeutic networks experienced in medical device trials allowing Medpace to select the ideal geographies and sites to ensure key milestones are met
  • Regulatory affairs staff provide guidance in selecting the optimal regulatory pathway and have the experience to coordinate and lead meetings with FDA and EU notified bodies
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Case Study

Pre-market case study

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Case study

Post-market case study

Medical Device Specialties

We apply everything we’ve learned throughout our extensive experience conducting pre- and post-marketing medical device clinical studies across many therapeutic areas to your study. You’ll work with teams who specialize in your specific therapeutic area and who understand and have overcome the challenges you face.

Cardiovascular Medical Device and Diagnostic Experience in Nearly Every Cardiac Specialty

Gain a competitive edge for advancing your cardiovascular medical device and diagnostic trials by leveraging our extensive experience and deep understanding of the regulatory, operational, and safety considerations needed to successfully conduct these clinical trials. Our impressive track record of success in cardiovascular clinical research brings you the expertise and resources to advance your medical device or diagnostic.

Our cardiovascular Sponsors benefit from:

  • Board-certified cardiologists with strong backgrounds in academic clinical practice and device development
  • Operational and Regulatory teams with significant global experience in both device and diagnostic studies, making them well-suited for the complexity of cardiovascular trials
  • Cardiovascular Core Lab to provide Sponsors with the most reliable, consistent, and timely electrocardiographic services and manage the rigors of safety studies
  • Medpace is a member of the Scientific Oversight Committee of the Cardiac Safety Research Consortium; a joint collaboration with the FDA, academia, and industry

A Comprehensive Cardiovascular Medical Device Portfolio

  • Coronary Artery Disease (interventional)
  • Congenital Heart Disease
  • Valvular Disease
    • Aortic valve replacement (transcutaneous and surgical)
    • Mitral valve repair (transcutaneous and surgical)
  • Cardiac Surgery
    • Coronary bypass grafts
    • Vessel occluders
  • Heart Failure
    • Left ventricular assist devices
    • Chronic resynchronization therapy
    • Autonomic stimulation
  • Electrophysiology
    • Pacemakers/Implantable cardioverter defibrillators
    • Ablation catheters
    • Mapping systems
  • Endovascular/Interventional
    • Peripheral vascular disease
    • Carotid artery disease
    • Thrombectomy/Embolic protection
    • Aortic aneurysm

Accelerate Your Research With Our Experience

Put 30 years of medical, regulatory, and operational experience to work for your metabolic medical device or diagnostic clinical trial. Founded in 1992 as a specialized CRO for metabolic and endocrine products, Medpace brings unrivaled knowledge and experience to help advance medical device and diagnostic products for diabetes, obesity, and weight loss indications. Our dedicated teams – led by therapeutic and regulatory specialists – ensure your project receives the collective knowledge, talent, and relationships of our seasoned experts.

Medpace’s experience with metabolic and endocrine products spans hundreds of global sites and thousands of patients, including glucose monitoring devices, insulin delivery devices, gastric stimulation, and gastric volume restrictive devices (balloon devices and organic, expandable capsules).

Medpace capabilities for endocrine-metabolic studies include:

  • Medical and regulatory experts who have helped pioneer many preventative metabolic medical devices
  • Close working relationships with investigators, which leads to more accurate feasibility, better recruitment, and improved retention
  • Operational staff with a proven track record of successful retention techniques, lifestyle education, and specific site issues associated with diabetes and obesity trial management
  • Medpace central labs, located in the U.S., Europe, China, and Singapore, offer one of the most extensive selections of metabolic biomarkers for clinical trials

Drug-Device Combination Products – Unparalleled Expertise

With our dedicated Medical Device specialists and our industry-leading experience in metabolic and endocrine drug development, Medpace brings together its medical and regulatory experts into a collaborative team that understands the nuances from both the drug and device perspectives. This provides you with a holistic and integrated path to approval.

Our experience with large-scale multinational trial programs, including emerging markets, and our broad compound experience for Type 1 and Type 2 diabetes, major obesity programs, hypercholesterolemia, mixed dyslipidemia, and/or with very high triglycerides, provides a strong backdrop for sponsors with drug-device combination

The Medpace Difference for Neuroscience Medical Device

The inherent complexities of neurological clinical research require a full-service CRO partner who has the internal resources, KOL and site relationships, global reach, and regulatory know-how to design and execute for success for neuroscience medical devices. As a therapeutically-specialized CRO with a focus on neuroscience, our medical, regulatory, and operational experts can help accelerate the approval of your medical device or diagnostic. 

Our experience includes diagnostic devices utilized to guide treatment in subjects with Major Depressive Disorder, nerve stimulators for neurodegenerative disorders and foot drop as well as neurostimulation devices for various indications.

Gain a competitive edge in your neuroscience medical device trials through:

  • Neurologists and psychiatrists who provide the strategic direction of study design and planning, train operational staff, work with Primary Investigators (PIs), provide medical monitoring services, and meet with regulatory agencies for neuroscience projects
  • Well-profiled network of sites with neuroscience experience to support effective enrollment and data quality
  • Global regulatory experts ensure that your studies are carried out in a fully-compliant manner to meet your objectives as efficiently as possible
  • Ability to navigate the nuances of drug-device combination products
  • Medpace Imaging Core Lab  with neuroimaging experts to ensure the highest quality imaging acquisition and interpretation
  • Our proven unique clinical trial management model ensures each milestone is met as efficiently, rapidly and effectively as possible
  • Real-time data review model provides accurate metrics and data efficiency

Work with an Experienced Surgical & Wound Care Medical Device CRO

Finding the best partner to execute the study of a surgical device requires a CRO who understands the necessary resources and relationships in working with sites around the world. Medpace has conducted hundreds of studies — from single-center, first-in-human, and feasibility trials to multi-center, full-service pivotal trials, and large-scale, post-market outcomes studies. Over 75% of these have been hospital-based and over one-third of those have been in the operating room. Our global footprint and well-profiled network of sites with surgical capabilities drive timely enrollment and data quality.

Our work in surgical device and diagnostics covers numerous therapeutic areas including:

Medical Devices for Wound Care

Medpace has a wide array of experience in medical devices that diagnose/treat wounds and promote healing. From allografts and membranes to gaseous and surgical treatments, we have the management experience and regulatory expertise to navigate the often confusing and complex regulatory and clinical pathway of getting your wound care product on the market.

Helping Your Diagnostic Clinical Trial Reach Its Full Potential

Medpace helps accelerate the advancement of in-vitro diagnostics (IVD) and other diagnostic tools with a comprehensive offering of services and expertise:

  • Strategic regulatory affairs leadership provides early guidance and execution for developing diagnostics
  • Specialized medical expertise in key areas of development including hematology and oncology, infectious diseases, and gene and cell therapies
  • Protocol development, and high-volume site and investigator selection sets the stage for enrolling large patient populations
  • Experience with varied medical settings including bed-side, laboratory or other healthcare professional settings
  • Wholly-owned Central Laboratories and Bioanalytical Laboratories provide integrated biomarker research support
    • Development and validation of diagnostic assays for use in clinical trials
    • Sample management
  • Relationships with specialized genomics labs

Precision Medicine – Companion Diagnostics

Matching the right drug to the patient based on each person’s biological makeup is the foundation of precision or personalized medicine. A companion diagnostic – defined as “an in vitro device that is essential for the safe and effective use of a drug” is the backbone of identifying those matches. Typically classified as Class III devices, companion diagnostics require more rigorous regulatory controls that can increase complexity, extend timelines, and add costs. Given these added complexities, it is critical to partner with a CRO with the medical and regulatory leadership who can help navigate to success with your diagnostic clinical trial.

The Medpace Combo: Drug-Medical Device Combination Products

Our dedicated medical device division is embedded within the global Medpace CRO providing greater knowledge, better coordination, and a holistic approach to your clinical development for drug-device combination products. We combine medical, regulatory, and operational experts from both drug and device perspectives into a collaborative team that understands the nuances and global landscape of each side. With this specialized combination of expertise, we can help you determine the best regulatory pathway to accelerate the approval of your drug-medical device combination or drug delivery product.

Related Medical Device and Diagnostic Insights

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On-Demand Webinar

Drivers and Trends in Cardiovascular Device Development: Insights from Key Opinion Leaders