David Novotny, COOThe company specializes in the full product lifecycle and offers an outsourcing (Functional and FSP) support model for manufacturers of all sizes across various geographies. Its focused areas of excellence include science, technology, strategy, operational advisory, and delivery of quality deliverables.
“One of the primary challenges faced by companies in the industry is product adoption of needed lifesaving technology while ensuring that cost remains within the spend curve of development. RQM+ assists its clients in building fit-for-purpose strategies for trials with economic models that deliver valuable, real-time accessible data," says David Novotny, COO.
Another significant challenge is the global economic climate, marked by inflation and the lingering effects of the COVID-19 pandemic, which led to a significant drop in interventional procedures in hospitals and outpatient clinics worldwide. This resulted in delays in studies, market entry, and an economic impact on market share and commercialization efforts.
However, over the past 12 to 15 months, there has been an increase in clinical research activities in areas such as cardiology, infectious disease, digital health, general surgery, robotics, and diagnostics. Recognizing this surge, RQM+ supports its clients with scenario planning, adaptive strategies, and enrollment efforts to expedite clinical studies and reach patients more efficiently.
“As a full-service CRO, RQM+ is a vested partner for clients and offers end-to-end functional services. Unlike approaching multiple partners to run an organized trial, we provide our clients with a single point of contact,” says Novotny.
The company’s services include project management, safety and medical affairs management, data management and biostatistical support, clinical monitoring, medical and scientific writing, regulatory support, quality audits, and biocompatibility and E&L testing for medical products.
RQM+ focuses on four key areas—software as medical devices (SaMD), combination products with device delivery, diagnostics, and medical devices. This holistic, specialized expertise helps the company tailor solutions across a diverse range of medical technologies and regulatory requirements.
RQM+'s full-spectrum support ranges from initial lab testing to regulatory submissions and post-market follow-ups to meet the needs of various types of clients, including small start-ups, mature tier-twos, and large organizations.
RQM+ also has different pricing models based on client types and environments, ensuring cost efficiency in the current economic climate. The company contracts with sponsors in various ways, including early start-up engagements offering clients financial flexibility.
“Our approach and methodology are based on agility, cost-effectiveness, and efficiency. We also operate in a functional service provider (FSP) capacity if a company approaches us for large-scale data management support on a portfolio or staff augmentation for specific functions based on sponsor requests,” says Hans Werner Voss, senior VP of operations.
Our electronic cloud-based system enables us to share information with clients 24/7, ensuring fast and reliable service
Success stories like these are possible because RQM+ goes beyond just delivering results. It focuses on building strong client relationships and ensuring their satisfaction throughout the entire process. This commitment is evident in its high-touch approach, which prioritizes clear communication and active engagement. Its positive customer surveys and track record of success speak volumes about its dedication to adding value and driving real results for clients.
A Medtech-Dedicated Clinical Research Organization
RQM+’s key therapeutic markets include cardiology, orthopedics and spine, gastroenterology, general surgery, women's health, respiratory, and urology.
With an experienced and expert team, the company reduces the commercialization risk by offering a full complement of CRO services to progress medical devices, digital therapeutics, and diagnostics onto the market and keep them there.
"Clinical research is fast-moving, and our sponsors demand efficiency and transparency. Documentation and communication are critical in our business. Our electronic cloud-based system enables us to share information with clients 24/7, ensuring fast and reliable service," says Novotny. "With the expertise of Dr. Voss and our team in Germany, we are automating clinical research processes to ensure we provide top-notch service to our global clients."
Road Ahead
Looking ahead, RQM+ is focused on growth and technological innovation. The demand for R&D is on the rise in Europe and the U.S., and the company is expanding its presence in the Asian market. With a focus on key areas such as software as a medical device (SaMD), combination products, diagnostics, and medical devices, RQM+ plans to support clients across various therapeutic backgrounds.
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"We continue to invest in technology and people, ensuring high customer satisfaction and repeat business," explains Novotny. "Our aim is to maintain and expand our quality services globally."
RQM+ is also exploring the potential of AI to enhance its services further. The company recently launched Fern.ai, the first human-in-the-loop AI platform that standardizes all aspects of clinical evidence literature review for regulatory affairs professionals to deliver audit-ready, exportable results in 60 percent less time than a manual process and 40 percent less time than alternative technology platforms.
The company also plans to expand its AI capabilities into other areas to optimize and speed up clinical trials in the future.
As the company continues to grow and embrace new technologies, it remains committed to meeting the evolving needs of its clients and driving the future of clinical research. It empowers manufacturers to navigate the evolving clinical research landscape with confidence, accelerating life-altering innovations for patients.
