EXCEPTIONAL SERVICE, GLOBAL REACH

With the Coronavirus COVID-19 health emergency, we have been contacted by several customers who are concerned with possibility of clinical trial participants coming off study medication due to their concerns with traveling to their study site. In an effort to address these concerns, Paragon Global CRS has made arrangements with its ground transportation providers to provide secure private delivery services of investigational product to trial participants.

In accordance with FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic:

“If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods. For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended. In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented.”