Skip to main content

Regulatory & Access Resources

Browse our regulatory & access resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Beyond Borders: Achieving Global Value From Local Observational Research

Find out more about balanced observational research strategies here!

Download PDF

A balanced observational research strategy that integrates local expertise and data requirements with a global research infrastructure can become the critical foundation for the collection of high-quality clinical and patient-reported data necessary to enhance a sponsor’s competitive positioning in each of its major markets.

In this paper we will discuss the five requirements for local affiliates to conduct credible observational

research, utilizing a centralized research infrastructure, to demonstrate product value in support of both local
and global commercial objectives: 

1.  Define and design the strategy and communications plan: begin with the end in mind

2.  Embrace local stakeholders’ needs at the global level

3.  Provide ongoing scientific oversight and operational leadership to the observational research

4.  Integrate local and global resources to optimize operational efficiencies

5.  Implement a multifaceted communications plan