What would you/your site do?
Hi everyone. I'm hoping this is a good place to ask for some perspective because I'm struggling to understand how my organization is handling a situation involving study drug/IP management.
For context, I work as a regulatory coordinator for a division of a large research institution that supports clinical trials at community clinics that don't have their own research departments. Our department provides the research infrastructure remotely, while designated nurses at the clinics assist with study procedures under the guidance of our coordinators.
Historically, IP for these community sites was shipped by sponsors to our institution's research pharmacy. The pharmacy received the shipments, maintained IP accountability, dispensed the drug, and shipped pre-dispensed medication to the community clinics for subjects' upcoming visits.
The pharmacy identified several concerns with this process, including that they remained responsible for the drug while it was outside of their control during transit, and there was limited site-level documentation of receipt and dispensing. They also informed us in October 2025 that they would no longer support these community sites because they interpret institutional policy to apply only to studies conducted within our own institution—not at partner clinics that belong to other health systems.
To me, the next step seemed straightforward: transition IP management to the pharmacies at the community sites by onboarding their pharmacy staff as key personnel, training them on study procedures and IP accountability, and updating sponsors with the new shipping locations. The issue with that is that some sponsors would only ship IP to one location, and several of our studies are OTA at more than one location. In this case, we could only have IP shipped to our main office, but that would require our remote coordinators to receive shipments at the office and transport them to the sites, which is a lot of work and travel that would necessarily take away time from other study activities where we needed them.
Its now more than eight months later and no operational changes have been initiated. Rather than developing an alternative workflow, leadership has only said they are trying to convince the research pharmacy to continue supporting these sites. Updates have been infrequent and generally amount to waiting for responses to emails, with little indication that contingency planning is happening.
This feels concerning to me because responsibility for IP is such a fundamental part of study operations, and the uncertainty has continued for months.
Has anyone dealt with a similar situation? Does this timeline seem reasonable, or would you have expected leadership to pursue parallel solutions while discussions with the research pharmacy continued? I'd really appreciate any insight from others, especially anyone who experienced something similar.