ATTENTION: Read Paragon Global CRS Statement Regarding COVID-19
Paragon Global CRS Announces Investigational Product Delivery Service
March 20, 2020 Wilmington, NC
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.”
Following the above guidance, we are also able to transport medical personnel to and from subjects, with dedicated cars and drivers.
Please contact us for more information on how we can tailor this service to the needs of your trial.
EXCEPTIONAL SERVICE, GLOBAL REACHParagon Global CRS is a clinical research support company specializing in the production of pharmaceutical meetings and provides patient travel and expense reimbursement services.
HOW CAN WE SUPPORT YOUR RESEARCH?
Event & Meeting Planning Services
Clinical Patient Support Services
Since 1995, Paragon Global CRS has dedicated our service to supporting clinical research through the professional production of pharmaceutical meetings and management of patient support services. From Chicago to Tel Aviv, Sydney to Bangalore; whether acquiring international visas or organizing shipping with foreign customs officials, our teams have the expertise and local knowledge to ensure that your program runs seamlessly.