When bias creeps into a clinical study, the result can be a dubious reception by regulators and the scientific community. The solution is careful study design to minimize bias. In this blog post – a continuation of our series on common pitfalls in clinical study...
When you partner with experienced and capable investigators and research teams, you’ll be able to execute your clinical study in the most efficient and cost-effective way possible. At the other extreme are studies that get mired in the weeds of site bureaucracy and...
In celebration of Earth Day and the sense of renewal that invigorates us each spring, BRIGHT is thrilled to share an update about our partnership with Neighborhood Forest. This Minnesota-based non-profit provides thousands of...
The randomized controlled trial (RCT) is the gold standard of clinical research, providing the highest level of scientific data for evidence-based medicine, and is often referred to as “Level I” in literature reviews and meta-analyses. RCTs are usually the most...
What did the case report forms say to the research coordinator? You complete me. Valentine’s Day mushiness aside, case report forms (CRFs) are a critical aspect of clinical research. They bring the protocol to...
Most leadership teams would agree that it is better to meet the timeline of a well-thought-out clinical study schedule than repeatedly miss the mark on an over-zealous one, even if the timeline is longer. No matter what your advisors told you, do not commit to your...
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,...