Learn More About Our Medical Device Expertise
For your convenience, our white papers, overviews and fact sheets can be accessed here.
An examination of study design, considerations and endpoints Transcatheter aortic valve replacement (TAVR) changed the treatment of high-risk patients with severe aortic stenosis, while also raising concerns of complications, such as increased risk for stroke. The entry of embolic protection … Read More
New Device Technologies Influence Treatment Options and Clinical Trials Choosing valve repair or replacement for most patients relies on the clinical judgement of their cardiologist and cardiac surgeon based on factors including overall health, the valve in question, and the … Read More
Understanding the Key Differences in the Clinical Trial Process Whether developing a new drug or medical device, designing and running clinical trials can be daunting. How drugs and devices are developed differ dramatically. Study design and regulatory pathways differ; requirements … Read More
Seven Tips for More Effective Cardiovascular Device Trials The increasing cardiovascular patient population, regulatory and payer demand for improved and cost-efficient patient outcomes and evolving technologies are driving innovation, especially among small and mid-sized cardiovascular device companies. This paper examines critical … Read More
As a specialty medical device CRO, we have gained a comprehensive understanding of the distinct needs and requirements of clinical device development programs. Our approach provides medtech companies both personalized regulatory consulting – critical early in the development phase – as … Read More
Streamline Combination Product Development The shifting borders among traditional drugs, biologics and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients. But such novel combination products pose numerous … Read More
Four Key Strategies to Manage Interventional Cardio Device Trials While heart disease is the leading cause of death worldwide, thankfully significant advances in technology-based treatments for cardiovascular disease have been made in recent years. Sponsors seeking to bring implantable cardiovascular … Read More
The Roadmap to Outsourcing Medical Device Trials Consider this a roadmap for both large and small medical device companies looking to outsource clinical trials. Utilizing external resources can be attractive to device manufacturers due to both the financial and operational … Read More
Novella Clinical’s core competency and therapeutic specialty is in cardiovascular device trials — comprising more than 50 percent of our medical device portfolio. Our specialized project teams consist of device-industry trained professionals with experience in sponsor, hospital and regulatory agency … Read More
Our specialized project teams consist of device-industry trained professionals. We understand the unique nuances of orthopedic and neurological device development programs. Download this resource to understand why Novella has earned preferred vendor status with several of the world’s largest medical device companies.
Novella Clinical’s rescue team resolves backlogs and gets study timelines back on track A global cardiovascular medical device company approached Novella Clinical to rescue a clinical trial in progress in nearly 20 countries. The clinical operations team was not happy … Read More