We’re taking time to reflect on the blog topics we shared in 2021, the experience we gained, and the inspiring work we did to help clients strategize, design, and execute successful clinical studies to meet their goals. These achievements were all made possible by the...
When a clinical study will be used to support an FDA market authorization application, it’s likely the agency will require a Bioresearch Monitoring (BIMO) inspection. Similar to our advice on clinical study design, it’s critical to “begin with the end in mind,”...
It may seem counterintuitive that collecting too much data is a common pitfall in clinical study design. After all, clinical studies are labor-intensive, time-consuming, and expensive, so why wouldn’t you try to get everything you can out of your study? In this blog...
Every medical device clinical study has endpoints, although they may be called something else, such as outcomes or metrics. Regardless of the name, we are talking about the objective, measurable results of a clinical study that are used to evaluate safety,...
As I prepare to retire from my long and rewarding career in clinical research, I’ve reflected on key learnings to share with my amazing BRIGHT team members and fellow study monitors in the medical...
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...