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“Microbiome” has become a consumer product buzzword, found in advertisements for soap and dozens […]
In a statement last August, departing FDA Commissioner Scott Gottlieb outlined several steps the agency had […]
Site selection is one of the most crucial parts of planning a study. Ensuring that sites are performing up to par while a trial is underway is equally important but often neglected. Biorasi was asked to assist in a phase II trial of stem cell therapy for traumatic brain injury (TBI).
Not every study presents a completely new and unique set of challenges. That’s not to say that the trial is generic, or not complex, but rather that Biorasi’s past work covers a large breadth and depth of experience. That experience allows us to see a lot of potential trial-stopping issues before they happen, and account for them in our planning. When we were asked to complete a trial on an acute lower back pain medication, we needed to identify potential pitfalls early in the planning process to make sure they wouldn’t lead to surprises later.
Flexibility and Strong Process-driven Planning Overcomes Regulatory Speed-bumps
CNS trials especially can become mired down and derailed by a too-low enrollment rate, and the culprit is usually poor venue and site planning and selection. Patient Enrollment Needs To Be Strategic, Not Just Tactical. Learn more in this case study