As an integral part of IVD clinical research, a sound biostatistical strategy is essential to achieving commercialization. Regardless of the intended market, end user or purpose of your product, there is one design element that needs to be the center of your strategy. Learn how to understand your assay’s precision profile and how to apply it to your clinical research, data management and biostatistical reports to facilitate market approval.
Topics to be covered during this webinar include:
- What precision profiles are and how they need to be a part of clinical study design.
- How precision profiles determine limits of B, D and Q.
- How accuracy/bias tie into precision profiles.