by Andrea Fenton Abbs | Jul 12, 2022 | Study Execution
A well-planned site selection process is essential for the smooth execution of your clinical study. How do you choose the best sites considering all the choices available? Do you need a key opinion leader (KOL) as your national principal investigator? Some sites are...
by Andrea Fenton Abbs | Jan 25, 2022 | ClinReg Strategy
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...
by Andrea Fenton Abbs | Dec 14, 2021 | BRIGHT Culture
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...
by Andrea Fenton Abbs | Nov 9, 2021 | Study Execution
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,”...
by Andrea Fenton Abbs | Oct 12, 2021 | Study Execution
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...
