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
Novella offers device-industry trained team members from clinical research and regulatory associates to data and project managers. Download a list of our core services and therapeutic experience here.
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.
As a specialty medical device CRO, we have gained a comprehensive understanding of the distinct needs and requirements of your program. Learn 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
Understanding Premarket Device Development The global medical device industry is facing strengthening competition, rapid technological innovation and increasing regulatory scrutiny while growing at an impressive rate. This paper provides an overview of the current premarket device development arena and global … 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
Our specialized project teams include board-certified cardiologists as well as a network of cardiovascular-experienced CRAs. Download this resources for an overview of our cardiovascular trial experience, which includes sponsor, hospital and regulatory agency environments.
Strategies on 510(k) Premarket Reform The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) issued draft guidances to revise its 510(k) premarket notification process for medical devices. The revisions aim to bring efficiencies and … Read More
A global cardiovascular medical device company approached Novella Clinical to rescue a clinical trial active in nearly 20 countries. Novella Clinical’s rescue team resolves backlogs and gets study timelines back on track.