The Burden of Safety Reporting on Sites: An Oncology Site’s Perspective
The map below displays WCG locations. The same locations are listed below the map.
Current safety reporting requirements place a heavy burden on sites. Sponsors and CROs struggle to keep up with changing global regulations and often end up overdistributing, sending duplicate or unnecessary reports. A review of 9 years of safety reports found that 86% of all safety letters received by oncology sites were uninformative or unnecessary, 54% did not meet FDA expectedness criteria and 50% did not meet FDA causality criteria. That applies to thousands of SUSAR distributions a month.
During this webinar, we will hear from Elena Jouravleva, PhD, Director of Regulatory for US Oncology Network, on the site perspective of safety reporting. Some questions we will discuss with her are:
- What is the experience of an oncology site in 2021 in processing SUSARs and other safety reports sent by biopharma and CROs?
- Is there anyone who does it best? If so, what makes this process better for the site?
- Have you required any biopharma companies to pay you more for the burden they place on you to handle safety reporting?
- Are there any biopharma companies you’ve refused to work with because of the onerous burden of their safety reporting?
- What would you want to tell every biopharma company to do differently to improve your site’s experience with processing safety reports?
- Elena Jouravleva, PhD, Director of Regulatory at Oncology Network
- Steven Beales, Senior Vice President, Scientific and Regulatory at WCG
- Jim Bannon, PharmD, President, Scientific and Regulatory Review at WCG