At RQM+, our clinical trials team has a deep understanding of the regulatory landscape and therapeutic-specific requirements for medical devices, in vitro diagnostics (IVD, CDx, LBX), and digital therapeutics (SaMD). From early feasibility, pilot, pivotal to post-market surveillance, we provide a full suite of services to support your product’s journey from development to market across a wide range of therapeutic areas. Our experience spans a wide range of complex, focused therapeutic study designs such as cardiovascular, oncology, general surgery, ophthalmology, orthopedics, respiratory, wound care/surgical closure, urology and gastroenterology.
Therapeutic areas in clinical research focus on understanding diseases and testing interventions. They help categorize medical research efforts, enabling experts to concentrate their skills and resources on specific health challenges. Fields such as oncology, cardiovascular, and neurology are among the most heavily researched areas, reflecting the complexity and prevalence of these conditions. At RQM+, we support a broad spectrum of therapeutic areas, ensuring that each clinical trial is expertly tailored to the needs of the product and patient population.
Find support for various clinical trial therapeutic areas. Book a consultation today.
Our expertise in cardiovascular and interventional cardiology support trials for complex technologies like drug-eluting stents and heart valves. Cardiovascular research is a prominent therapeutic area globally, addressing some of the most common causes of death, such as coronary heart disease and stroke. RQM+ guides you through complex regulatory processes, ensuring your products meet rigorous global standards.
Oncology remains the most researched therapeutic area due to the high incidence and mortality rates of cancer, as well as ongoing technological advancements. Our team supports clinical trials for devices and diagnostics targeting cancer treatment and management, helping you navigate the challenging regulatory environment. We ensure your clinical evaluation plans are built to tackle the unique demands of oncology, where precision medicine and targeted therapies are transforming patient care.
Respiratory diseases like COPD and asthma affect millions worldwide, making respiratory care a crucial therapeutic area. RQM+ supports clinical trials for both invasive and non-invasive respiratory devices, ensuring that your product meets the highest standards for safety and efficacy. We also help you stay compliant with EU and US post-market surveillance regulations.
RQM+ supports innovations in general surgery, from advanced robotic systems to surgical diagnostics. Our team ensures that your products meet international regulatory standards, while our post-market surveillance services ensure their ongoing safety and efficacy. Clinical trials in this space are pivotal in advancing surgical outcomes globally.
RQM+ offers specialized clinical trial services for women’s health products, including reproductive health technologies and surgical devices. Clinical research in women’s health is evolving, focusing on improving diagnostic accuracy and treatment efficacy for various conditions. Our regulatory and clinical evaluation expertise ensures that your products are compliant and effective.
RQM+ supports clinical trials for diagnostics and devices targeting infectious diseases, a therapeutic area that has gained increased attention post-pandemic. Our team helps structure clinical trials to meet both EU and US regulatory standards, ensuring rapid market entry and robust post-market surveillance strategies.
RQM+ provides clinical trial services for orthopedic and spine devices, including joint replacements and spinal implants. Orthopedics continues to be a rapidly growing field, driven by technological advancements in materials and surgical techniques. We guide you through every phase of the regulatory process, ensuring your product meets the required standards.
We offer full support for clinical trials in urology, helping manufacturers navigate the regulatory landscape for medical devices. From clinical trial design to post-market compliance, RQM+ ensures your urological devices reach the market safely and efficiently.
Clinical research in neurology is essential for advancing treatments for central nervous system disorders, including Alzheimer's and Parkinson’s disease. RQM+ provides regulatory and clinical trial expertise, ensuring compliance with both FDA and EU MDR standards. We also assist with post-market surveillance to guarantee long-term device performance.
RQM+ supports clinical trials for advanced wound care products, such as antimicrobial dressings and skin substitutes. We help you navigate complex regulatory submissions and ensure your product meets global standards for safety and efficacy.
RQM+ offers clinical trial expertise in ophthalmology, covering everything from diagnostics to advanced surgical tools. Our team helps ensure your trials meet regulatory standards and provide high-quality clinical evidence to support approval and market success.
RQM+ brings unmatched regulatory, design and clinical trial expertise to a wide range of therapeutic areas. Our services help ensure compliance with global standards like EU MDR, ISO and applicable FDA requirements, supporting you through the global landscape and development lifecycle.
Ready to accelerate your clinical trials? Get in touch.
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