peri & postapproval studies

Hybrid Study Designs for Demonstrating Real-World Product Safety, Effectiveness and Value

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.


Top Study Designs for Late Phase Research

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. 

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