The Syneos Health Podcast

A Regulatory Roadmap for Real World Evidence

August 28, 2019 Jeffrey Stewart / Stuart McCully / Tara Isherwood Episode 42
The Syneos Health Podcast
A Regulatory Roadmap for Real World Evidence
Chapters
The Syneos Health Podcast
A Regulatory Roadmap for Real World Evidence
Aug 28, 2019 Episode 42
Jeffrey Stewart / Stuart McCully / Tara Isherwood

The need for real world evidence is growing beyond its original footprint of post-market intelligence, with uses now including regulatory approval, proof of value, maximized access and more.  However, without a true understanding of the regulatory requirements around real world evidence, there is a risk of a “Goldilocks effect”— gathering either not enough information, the wrong information, or far more information than they need. 

Stuart McCully, PhD, Vice President and Tara Isherwood, Senior Director, Real World Clinical Consulting, discuss the key information developers need in order to plan studies that will get them the intel that they need, the right way.

For more on real world evidence from across Syneos Health, check out our interviews with Alastair MacDonald in Episode 31, and Dave Thompson in Episode 1.

Like what you’re hearing?  Be sure to rate and review us!  

We want to hear from you!  If there’s a topic you’d like us to cover on a future episode, contact us at [email protected]

Show Notes

The need for real world evidence is growing beyond its original footprint of post-market intelligence, with uses now including regulatory approval, proof of value, maximized access and more.  However, without a true understanding of the regulatory requirements around real world evidence, there is a risk of a “Goldilocks effect”— gathering either not enough information, the wrong information, or far more information than they need. 

Stuart McCully, PhD, Vice President and Tara Isherwood, Senior Director, Real World Clinical Consulting, discuss the key information developers need in order to plan studies that will get them the intel that they need, the right way.

For more on real world evidence from across Syneos Health, check out our interviews with Alastair MacDonald in Episode 31, and Dave Thompson in Episode 1.

Like what you’re hearing?  Be sure to rate and review us!  

We want to hear from you!  If there’s a topic you’d like us to cover on a future episode, contact us at [email protected]