Hybrid study designs which aim to result in high quality data, collected in a rapid and time-efficient manner may be an option when more traditional approaches are not suitable. We have developed a strategic and step-wise approach for the development of optimal study designs to address research questions which warrant multiple data sources including primary or secondary sources of real-world data.
peri & postapproval studies
In a recent posting, we provided the Top 10 Reasons to Conduct Late Phase Research. Focused and strategic peri and postapproval research, culminating in definitive evidence of product value, can make a significant impact on market access and product uptake.
As the value demonstration evidence needs in support of a product take shape, important tactical questions begin to surface.