When designing a medical device clinical study, if you don’t begin with the end in mind, you’re likely to encounter costly surprises during the study or in the subsequent regulatory application process. With patient safety, product success, and business objectives...
Work-life balance. Mindfulness. Self-care. Is there a fly in here, or just the sound of buzzwords? Work-life balance isn’t a buzzword for us. It’s a cornerstone value in our human-first approach to doing business as a full-service clinical research organization. In...
You are developing a medical device that addresses a clinical need, but how do you get it into the hands of physicians to improve the lives of patients? In this article, we discuss the most common FDA pathways to market clearance and share a few insights to help you...
The voluntary FDA Q-Submission Program, specifically the pre-sub meeting process, can serve as a powerful tool to streamline and optimize your medical device product development strategies, timelines, and budget, especially if you need to conduct a clinical study. In...
The medical device product development cycle can take several years and cost millions of dollars, especially when a clinical study is required. With an investment that large, it’s smart strategy to ensure your study design is locked-in well before you submit an...
Welcome to our new blog! I founded BRIGHT Research Partners in 2008 with the dream of creating a full-service clinical research organization that placed high value on beautiful deliverables, exceptional customer service, smart strategies, and a human-first philosophy...