Ashley Herrick, Ph.D.
Executive Director Oncology Strategy
In recent years, we have seen a shift toward decentralized and hybrid clinical studies that help bring clinical trials to patients and reduce the burden of study participation. COVID-19 accelerated this shift, increasing emphasis on patient access, safety, and engagement. Now, proactively incorporating community clinicians and sites into clinical research is the next step in broadening the reach and diversity of oncology studies while still generating high-quality data.
In this episode, Premier Research’s Dr. Ashley Herrick, Executive Director, Oncology Strategy; joins us in a conversation about:
Abie Ekangaki, Ph.D.
Vice President Statistical Consulting
Shari Medendorp, MPH
President Premier Consulting
COVID-19 has dramatically changed the way we conduct clinical trials and left many sponsors without answers when it comes to the future of their studies. Recognizing the issues is one thing, but figuring out where we go from here demands a new way of looking at some common challenges. In this episode, Premier Research’s Shari Medendorp, Senior Vice President of Biometrics, and Abie Ekangaki, Vice President of Statistical Consulting, join us to discuss:
As we continue to face the ongoing COVID-19 health emergency, the medical community is tasked with bringing solutions to patients in an expedited and safe manner. One such opportunity is to partner with the US FDA by submitting an Emergency Use Authorization (EUA) for any products that could immediately and effectively address a health emergency.
In this episode, Nach Dave, Premier Research’s Vice President of Development Strategy, discusses key considerations for sponsors interested in applying for an EUA, including:
• How it allows the FDA to help strengthen the nation’s public health options
• How to know if your product is a good fit
• Actionable steps you can take toward seeking an EUA
Read our blog at https://premier-research.com/perspectives/what-is-fda-emergency-use-authorization-eua/.
Contact our COVID-19 Task Force at [email protected].
