Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...
An estimated 300 million people globally suffer from a rare disease. Further still, 25 million people in the U.S. alone are living with an undiagnosed rare disease. Limitations in disease understanding and lack of approved treatments can mean countless challenges and diminished quality of life for many battling a rare disease. For all those looking...
Decentralized clinical trials (DCTs) have emerged as a promising solution to address the unique challenges of pediatric rare disease research. In this blog, we discuss the intricate landscape of conducting clinical research in pediatric rare diseases, identify the unique challenges, discuss the potential of decentralized trial strategies, and underscore relevant risks and considerations. Navigating the...
In the business of pharmaceutical and MedTech clinical development, the significance of robust data cannot be overstated. It serves as the cornerstone for informed decision-making and cultivates an environment where innovation thrives. However, when confronted with the task of comparing ethnicity data across diverse countries, a myriad of challenges and intricacies surface, warranting a thorough...
“You have cancer.” It’s something you hope to never hear. For so many of us at Premier Research, we’ve watched loved ones fight for their lives — or fought for our own. That’s why we choose to work at Premier, where our focus is bringing new treatments to patients so that we can help make...
Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those investigational devices might be covered not only to offset the cost of development, but also...
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often, clinical studies are conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions...
The increasing complexity of clinical trials requires a re-assessment of the functions of site management and monitoring. Both roles have traditionally been the purview of clinical research associates (CRAs), who have typically spent 60%-80% of their time on monitoring and only 20%-40% on site management. Traditionally, CRAs have a range of monitoring and site management...
Welcome to part two of our blog series focused on the integration of diversity, equity, and inclusion (DEI) into clinical research. If you missed part one of the series that highlights recent FDA initiatives and legislative changes behind these developments, click here. In today’s clinical research environment, sponsors face the challenge of comprehensively incorporating DEI...
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study for the purpose of collecting safety and effectiveness data.1 However, many in vitro diagnostic (IVD) devices are released from IDE regulations if certain criteria are met. In this blog post, we discuss how device studies are classified and explore...