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RWE and Phase IV: Operationalizing Enrollment and Engagement

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"RWE and Phase IV: Operationalizing Enrollment and Engagement"

This playbook explores how to enhance enrollment and engagement for larger RWD-dependent studies

Given that functions such as data capture and storage are necessary to turn RWD into RWE, sponsors generally know they need to operationalize trial functions. And many have already done so on the backend through electronic data capture (EDC) within clinical data management systems (CDMS). 

But while steps like EDC adoption help studies function at a Phase IV scale, they’re not the only processes worth operationalizing. Enrollment and engagement are important to operationalize, too, even though they are often overlooked.

In this playbook, we’ll discuss how to enhance enrollment and engagement for larger RWD-dependent studies—and why using the right tools and processes can support quality, compliant Phase IV RWE generation. You’ll learn:

  • Best practices for RWD capture of a Phase IV trial
  • How to integrate backend data management with a seamless upfront experience
  • How to manage costs when collecting patient-reported outcomes 
  • What to look for in a partner for your Phase IV study


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