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How to Control for Statistical Error in Clinical Studies

How to Control for Statistical Error in Clinical Studies

by Scott Brown, PhD | Oct 11, 2022 | Data Management

The notion of statistical error permeates clinical study design and analysis, forming the basis for regulatory decision-making in evidence-based medicine, where the vaunted p-value is a cornerstone of analysis. In addition, statistical error is a key factor in sample...
Clinical Study Design Pitfall #2: Insufficient Blinding

Clinical Study Design Pitfall #2: Insufficient Blinding

by Scott Brown, PhD | Jun 14, 2022 | Study Execution

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...
Randomized Controlled Trial: The Gold Standard of Study Design

Randomized Controlled Trial: The Gold Standard of Study Design

by Scott Brown, PhD | Mar 8, 2022 | ClinReg Strategy

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...
Five Key Qualities of Clinical Study Primary Endpoints

Five Key Qualities of Clinical Study Primary Endpoints

by Scott Brown, PhD | Sep 14, 2021 | Study Execution

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,...
Clinical Study Design – Begin with the End in Mind

Clinical Study Design – Begin with the End in Mind

by Scott Brown, PhD | Jul 13, 2021 | Study Execution

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...

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